Neil Osterweil

A diagnosis of diabetes mellitus does not disqualify a person from driving, but symptoms such as peripheral neuropathy and retinopathy, as well as treatment consequences such as hypoglycemia, can increase the risk of driving impairment, said Dr. Daniel Lorber, a specialist in diabetes and the law.

The ADA recommends that when considering the fitness for driving of a patient with diabetes controlled with insulin, the physician should evaluate patients’ hypoglycemia history and risk, ability to detect early hypoglycemia, their ability to self-monitor blood glucose and manage their disease, and whether they have diabetes-related complications that may impair their ability to drive safely, Dr. Lorber, director of endocrinology at New York Hospital, Queens, said at the annual advanced postgraduate course held by the American Diabetes Association.

"There really is a whole variety of variables in diabetes, not merely aging, and not merely hypoglycemia, that affect how people drive, but we do know that moderate hypoglycemia does impair driving safety," said Dr. Lorber, who also serves on the ADA’s legal advocacy subcommittee.

"You can’t make driving safe. Frankly, you can’t make crossing the street safe; you can just make diabetic driving less dangerous," he said.

Fifty-one licensing authorities

There is great variability among patients with diabetes, he noted, and decisions about driving ability have to be made on a case-by-case basis. The clinician’s task is made harder by the jumble of state licensing authorities (51, including the District of Columbia), and, for commercial drivers, federal licensing regulations from the U.S. Department of Transportation and the Federal Motor Carrier Safety Administration (FMCSA).

Regulations vary from one state to the next, but most require evaluation of patients with diabetes following a motor vehicle accident, and a few states, such as Pennsylvania, have specific referral requirements to the department of motor vehicles after a severe hypoglycemic event, with or without a motor vehicle. State mandatory reporting laws may put physicians who care for diabetes patients in a bind, caught between state requirements and the Health Insurance Portability and Accountability Act of 1996 (HIPAA) privacy mandates, Dr. Lorber said.

For commercial drivers who engage in interstate commerce, the federal government bans commercial licensure of people with insulin-treated diabetes, except those who meet stringent requirements that include being on insulin for a minimum of 1-2 months, no severe hypoglycemia in the past 12 months and no more than two severe episodes over the preceding 5 years, and no unstable retinopathy or other disqualifying condition. Additionally, commercial drivers must demonstrate diabetes education and willingness to manage their condition, maintain a driving and blood glucose log, check their blood sugars every 2-4 hours and only drive if their levels are between 100 and 400 mg/dL, submit quarterly and annual reports to the U.S. Department of Transportation, and report all motor vehicle accidents and adverse driving events.

A systematic review of the data on diabetes and driving risk prepared for the FMCSA had equivocal results, finding on the one hand that there was no evidence for a higher risk of crashes among people on insulin, but on the other hand that "hypoglycemia has a significant deleterious effect on the driving ability of some individuals with type 1 DM when measured using a driving simulator."

The review authors noted that in three small studies, there was a suggestion of a deleterious relationship between hypoglycemia and simulated driving tasks, but they saw no consistent pattern of impairment or the sensitivity of task impairments associated with specific levels of hypoglycemia.

Relatively low risk

Based on data from the systematic review, Dr. Lorber estimated the relative risk for motor vehicle accidents in persons with any type of diabetes to be 1.12 to 1.19 times higher than that of controls, and for patients with type 1 DM and a history of severe hypoglycemia within the prior 2 years: 1.5 to 2 times higher.

Both compare favorably to the accident risk for 16-year-old males compared with 35- to 45-year-old females (42-fold), rural vs. urban highways (9.2-fold more accidents on rural highways), and 1 a.m. Sunday vs. 11 a.m. Sunday (142 times higher at 1 am).

Dr. Lorber also pointed out that nondiabetic drivers are also exposed to risks from sedating over-the-counter medications sold in convenience stores and gas station mini marts, such as diphenhydramine (Benadryl)-containing products, Tylenol Allergy (acetaminophen with chlorpheniramine), or NyQuil, a cold medicine that contains the antihistamine doxylamine.

To make driving safer for those at risk for hypoglycemia, he recommends measuring blood glucose before driving and never driving with values from 70 to 90 mg/dL without first having prophylactic carbohydrates, never driving with a blood glucose below 70 mg/dL, and treating prophylactically during long drives,

Additionally, if the driver detects hypoglycemia while driving, he or she should immediately pull off the road and consume a fast-acting carbohydrate with dextrose, and not resume driving until the blood glucose is above 90 mg/dL.

"Have something readily available in the car – not in the trunk, not even in the glove compartment. It ought to be in the little pocket in the seat next to you or where the ashtray used to be," he advised.

The driver should also have a medical alert bracelet to alert police or passersby that they are not intoxicated but instead have diabetes should they lose consciousness, he added.

Dr. Lorber reported having no financial disclosures.

A diagnosis of diabetes mellitus does not disqualify a person from driving, but symptoms such as peripheral neuropathy and retinopathy, as well as treatment consequences such as hypoglycemia, can increase the risk of driving impairment, said Dr. Daniel Lorber, a specialist in diabetes and the law.

The ADA recommends that when considering the fitness for driving of a patient with diabetes controlled with insulin, the physician should evaluate patients’ hypoglycemia history and risk, ability to detect early hypoglycemia, their ability to self-monitor blood glucose and manage their disease, and whether they have diabetes-related complications that may impair their ability to drive safely, Dr. Lorber, director of endocrinology at New York Hospital, Queens, said at the annual advanced postgraduate course held by the American Diabetes Association.

"There really is a whole variety of variables in diabetes, not merely aging, and not merely hypoglycemia, that affect how people drive, but we do know that moderate hypoglycemia does impair driving safety," said Dr. Lorber, who also serves on the ADA’s legal advocacy subcommittee.

"You can’t make driving safe. Frankly, you can’t make crossing the street safe; you can just make diabetic driving less dangerous," he said.

Fifty-one licensing authorities

There is great variability among patients with diabetes, he noted, and decisions about driving ability have to be made on a case-by-case basis. The clinician’s task is made harder by the jumble of state licensing authorities (51, including the District of Columbia), and, for commercial drivers, federal licensing regulations from the U.S. Department of Transportation and the Federal Motor Carrier Safety Administration (FMCSA).

Regulations vary from one state to the next, but most require evaluation of patients with diabetes following a motor vehicle accident, and a few states, such as Pennsylvania, have specific referral requirements to the department of motor vehicles after a severe hypoglycemic event, with or without a motor vehicle. State mandatory reporting laws may put physicians who care for diabetes patients in a bind, caught between state requirements and the Health Insurance Portability and Accountability Act of 1996 (HIPAA) privacy mandates, Dr. Lorber said.

For commercial drivers who engage in interstate commerce, the federal government bans commercial licensure of people with insulin-treated diabetes, except those who meet stringent requirements that include being on insulin for a minimum of 1-2 months, no severe hypoglycemia in the past 12 months and no more than two severe episodes over the preceding 5 years, and no unstable retinopathy or other disqualifying condition. Additionally, commercial drivers must demonstrate diabetes education and willingness to manage their condition, maintain a driving and blood glucose log, check their blood sugars every 2-4 hours and only drive if their levels are between 100 and 400 mg/dL, submit quarterly and annual reports to the U.S. Department of Transportation, and report all motor vehicle accidents and adverse driving events.

A systematic review of the data on diabetes and driving risk prepared for the FMCSA had equivocal results, finding on the one hand that there was no evidence for a higher risk of crashes among people on insulin, but on the other hand that "hypoglycemia has a significant deleterious effect on the driving ability of some individuals with type 1 DM when measured using a driving simulator."

The review authors noted that in three small studies, there was a suggestion of a deleterious relationship between hypoglycemia and simulated driving tasks, but they saw no consistent pattern of impairment or the sensitivity of task impairments associated with specific levels of hypoglycemia.

Relatively low risk

Based on data from the systematic review, Dr. Lorber estimated the relative risk for motor vehicle accidents in persons with any type of diabetes to be 1.12 to 1.19 times higher than that of controls, and for patients with type 1 DM and a history of severe hypoglycemia within the prior 2 years: 1.5 to 2 times higher.

Both compare favorably to the accident risk for 16-year-old males compared with 35- to 45-year-old females (42-fold), rural vs. urban highways (9.2-fold more accidents on rural highways), and 1 a.m. Sunday vs. 11 a.m. Sunday (142 times higher at 1 am).

Dr. Lorber also pointed out that nondiabetic drivers are also exposed to risks from sedating over-the-counter medications sold in convenience stores and gas station mini marts, such as diphenhydramine (Benadryl)-containing products, Tylenol Allergy (acetaminophen with chlorpheniramine), or NyQuil, a cold medicine that contains the antihistamine doxylamine.

To make driving safer for those at risk for hypoglycemia, he recommends measuring blood glucose before driving and never driving with values from 70 to 90 mg/dL without first having prophylactic carbohydrates, never driving with a blood glucose below 70 mg/dL, and treating prophylactically during long drives,

Additionally, if the driver detects hypoglycemia while driving, he or she should immediately pull off the road and consume a fast-acting carbohydrate with dextrose, and not resume driving until the blood glucose is above 90 mg/dL.

"Have something readily available in the car – not in the trunk, not even in the glove compartment. It ought to be in the little pocket in the seat next to you or where the ashtray used to be," he advised.

The driver should also have a medical alert bracelet to alert police or passersby that they are not intoxicated but instead have diabetes should they lose consciousness, he added.

Dr. Lorber reported having no financial disclosures.

A diagnosis of diabetes mellitus does not disqualify a person from driving, but symptoms such as peripheral neuropathy and retinopathy, as well as treatment consequences such as hypoglycemia, can increase the risk of driving impairment, said Dr. Daniel Lorber, a specialist in diabetes and the law.

The ADA recommends that when considering the fitness for driving of a patient with diabetes controlled with insulin, the physician should evaluate patients’ hypoglycemia history and risk, ability to detect early hypoglycemia, their ability to self-monitor blood glucose and manage their disease, and whether they have diabetes-related complications that may impair their ability to drive safely, Dr. Lorber, director of endocrinology at New York Hospital, Queens, said at the annual advanced postgraduate course held by the American Diabetes Association.

"There really is a whole variety of variables in diabetes, not merely aging, and not merely hypoglycemia, that affect how people drive, but we do know that moderate hypoglycemia does impair driving safety," said Dr. Lorber, who also serves on the ADA’s legal advocacy subcommittee.

"You can’t make driving safe. Frankly, you can’t make crossing the street safe; you can just make diabetic driving less dangerous," he said.

Fifty-one licensing authorities

There is great variability among patients with diabetes, he noted, and decisions about driving ability have to be made on a case-by-case basis. The clinician’s task is made harder by the jumble of state licensing authorities (51, including the District of Columbia), and, for commercial drivers, federal licensing regulations from the U.S. Department of Transportation and the Federal Motor Carrier Safety Administration (FMCSA).

Regulations vary from one state to the next, but most require evaluation of patients with diabetes following a motor vehicle accident, and a few states, such as Pennsylvania, have specific referral requirements to the department of motor vehicles after a severe hypoglycemic event, with or without a motor vehicle. State mandatory reporting laws may put physicians who care for diabetes patients in a bind, caught between state requirements and the Health Insurance Portability and Accountability Act of 1996 (HIPAA) privacy mandates, Dr. Lorber said.

For commercial drivers who engage in interstate commerce, the federal government bans commercial licensure of people with insulin-treated diabetes, except those who meet stringent requirements that include being on insulin for a minimum of 1-2 months, no severe hypoglycemia in the past 12 months and no more than two severe episodes over the preceding 5 years, and no unstable retinopathy or other disqualifying condition. Additionally, commercial drivers must demonstrate diabetes education and willingness to manage their condition, maintain a driving and blood glucose log, check their blood sugars every 2-4 hours and only drive if their levels are between 100 and 400 mg/dL, submit quarterly and annual reports to the U.S. Department of Transportation, and report all motor vehicle accidents and adverse driving events.

A systematic review of the data on diabetes and driving risk prepared for the FMCSA had equivocal results, finding on the one hand that there was no evidence for a higher risk of crashes among people on insulin, but on the other hand that "hypoglycemia has a significant deleterious effect on the driving ability of some individuals with type 1 DM when measured using a driving simulator."

The review authors noted that in three small studies, there was a suggestion of a deleterious relationship between hypoglycemia and simulated driving tasks, but they saw no consistent pattern of impairment or the sensitivity of task impairments associated with specific levels of hypoglycemia.

Relatively low risk

Based on data from the systematic review, Dr. Lorber estimated the relative risk for motor vehicle accidents in persons with any type of diabetes to be 1.12 to 1.19 times higher than that of controls, and for patients with type 1 DM and a history of severe hypoglycemia within the prior 2 years: 1.5 to 2 times higher.

Both compare favorably to the accident risk for 16-year-old males compared with 35- to 45-year-old females (42-fold), rural vs. urban highways (9.2-fold more accidents on rural highways), and 1 a.m. Sunday vs. 11 a.m. Sunday (142 times higher at 1 am).

Dr. Lorber also pointed out that nondiabetic drivers are also exposed to risks from sedating over-the-counter medications sold in convenience stores and gas station mini marts, such as diphenhydramine (Benadryl)-containing products, Tylenol Allergy (acetaminophen with chlorpheniramine), or NyQuil, a cold medicine that contains the antihistamine doxylamine.

To make driving safer for those at risk for hypoglycemia, he recommends measuring blood glucose before driving and never driving with values from 70 to 90 mg/dL without first having prophylactic carbohydrates, never driving with a blood glucose below 70 mg/dL, and treating prophylactically during long drives,

Additionally, if the driver detects hypoglycemia while driving, he or she should immediately pull off the road and consume a fast-acting carbohydrate with dextrose, and not resume driving until the blood glucose is above 90 mg/dL.

"Have something readily available in the car – not in the trunk, not even in the glove compartment. It ought to be in the little pocket in the seat next to you or where the ashtray used to be," he advised.

The driver should also have a medical alert bracelet to alert police or passersby that they are not intoxicated but instead have diabetes should they lose consciousness, he added.

Dr. Lorber reported having no financial disclosures.

Bariatric surgery can significantly reduce the need for insulin and can even induce complete remission of type 2 diabetes mellitus, but some forms of the procedure pose too much risk and should be shunned, said a diabetes specialist at the annual advanced postgraduate course held by the American Diabetes Association.

Depending on the type of procedure, weight loss in the first year following bariatric surgery can range from about 30 kg to more than 50 kg, and the surgery can reduce the risk of mortality for formerly obese patients by about 25%, said Dr. John Bantle, professor of medicine and director of the division of endocrinology and diabetes at the University of Minnesota in Minneapolis.

Bariatric surgery should be considered in type 2 diabetic patients with a body mass index greater than 35 kg/m², and may also benefit patients with a BMI of 30-35, although there is not enough evidence to support the latter assertion, Dr. Bantle said.

"I would choose laparoscopic gastric bypass as the procedure to recommend. I think laparoscopic gastric banding doesn’t have enough efficacy, and duodenal switch has too many complications," he said.

Looking back at Look AHEAD

The most recent follow-up data from the Action for Health in Diabetes (Look AHEAD) study compared cardiovascular event rates among patients randomized to either an intensive lifestyle intervention or a diabetes support and education program. Analysis showed that the lifestyle intervention was associated with significantly more weight loss (–4.7% vs. –1.1% at 4 years, P less than .001), and with a more favorable change in fitness levels, hemoglobin A_1c, systolic blood pressure, high-density lipoprotein cholesterol levels, and triglyceride levels (P less than .001 for all comparisons) (Arch. Intern. Med. 2010;170:1566-75).

However, in September 2012, the National Institutes of Health, acting on the advice of the trial’s data and safety monitoring team, halted the lifestyle intervention because the primary endpoint of reduction in cardiovascular events had not been reached and would be unlikely to do so in the 2 years remaining in the study.

Although the trial failed to meet the cardiovascular endpoint, there was no evidence of harm, and patients who were randomized to the intervention had reduced need for diabetes medications, less sleep apnea, and increases in both physical mobility and quality of life.

"In data that are still under analysis and not yet published, I think we are going to see that there was some benefit on microvascular complications," Dr. Bantle said.

Choose procedures wisely

If lifestyle interventions are not sufficient, bariatric surgery may be helpful, Dr. Bantle said. Procedures commonly used in the United States include laparoscopic gastric banding, Roux-en-Y gastric bypass, and increasingly, sleeve gastrectomy and biliopancreatic diversion with duodenal switch.

The latter procedure is similar to a jejunoileal bypass, an early type of bariatric surgery that is no longer performed due to the high complication rate. Biliopancreatic diversion with duodenal switch involves division of the stomach and creation of a small gastric pouch that is drained with a loop of intestine attached downward to the ileum toward its head, so that biliary and pancreatic drainage occurs through the small intestine before the digestive juices meet up with food for digestion and absorption toward the end of the intestinal tract.

"I think this procedure is a really bad idea; it’s too much like a jejunoileal bypass with anastomosis, and I advise all my patients who are considering bariatric surgery to decline the option to pursue this procedure," he said.

Evidence favors surgery

Reviewing the evidence, Dr. Bantle pointed to a 2005 meta-analysis of 147 studies of bariatric surgery for obesity, which showed a mean 30.2-kg weight loss at 12 months and 34.8-kg loss after 36 months in patients who had a gastric banding procedure, compared with 43.5 kg and 41.5 kg, respectively, for gastric bypass, and 51.9 kg and 53.1 kg for those who had surgery with a duodenal switch procedure (Ann. Intern. Med. 2005;142:547-59).

The study also showed, however, that the rate of adverse events, including reflux, vomiting, dysphagia, and dumping syndrome, was markedly higher for patients who underwent a duodenal switch, at 37.7%, compared with 7.0% for gastric banding and 16.9% for gastric bypass.

A 2007 Swedish study also saw a reduction in mortality at a mean of 10.9 years of follow-up among 2,010 obese patients who underwent bariatric surgery compared with 2,037 patients who received standard medical management. The hazard ratio for death in the surgical patients was 0.76 (P = .04). The most common causes of death were myocardial infarction, which occurred in 13 surgical patients and 25 controls, and cancer, which occurred in 29 surgical patients and 47 controls (N. Engl. J. Med. 2007;357:741-52).

Similarly, a retrospective cohort study comparing 7,925 obese people who underwent gastric bypass surgery with the same number of obese controls matched by age, gender, and BMI showed that after a mean follow-up of 7.1 years, adjusted mortality for surgical patients was 37.6 per 10,000 person-years, compared with 57.1 per 10,000 for controls, a relative difference of 40%. Additionally, diabetes-specific mortality declined by 92% in the gastric bypass patients (N. Engl. J. Med. 2007;357:753-61).

Following surgery, it is important to ensure that patients have a protein intake of 60-120 g daily, and if they have undergone gastric bypass or duodenal switch procedures their diet should be supplemented with a multivitamin containing folate, thiamine, iron, vitamin B₁₂, calcium, and vitamin D, Dr. Bantle said.

"I would suggest that the earlier the surgery is done, the better. Remission of diabetes is predicted by short duration of diabetes, need for few diabetes medications, and high postprandial C-peptide, so if a patient is considering [bariatric surgery], I typically get a postprandial C-peptide and use that to counsel them about whether or not they’re likely to have remission of diabetes after the procedure," he concluded.

Dr. Bantle reported having no financial disclosures.

Bariatric surgery can significantly reduce the need for insulin and can even induce complete remission of type 2 diabetes mellitus, but some forms of the procedure pose too much risk and should be shunned, said a diabetes specialist at the annual advanced postgraduate course held by the American Diabetes Association.

Depending on the type of procedure, weight loss in the first year following bariatric surgery can range from about 30 kg to more than 50 kg, and the surgery can reduce the risk of mortality for formerly obese patients by about 25%, said Dr. John Bantle, professor of medicine and director of the division of endocrinology and diabetes at the University of Minnesota in Minneapolis.

Bariatric surgery should be considered in type 2 diabetic patients with a body mass index greater than 35 kg/m², and may also benefit patients with a BMI of 30-35, although there is not enough evidence to support the latter assertion, Dr. Bantle said.

"I would choose laparoscopic gastric bypass as the procedure to recommend. I think laparoscopic gastric banding doesn’t have enough efficacy, and duodenal switch has too many complications," he said.

Looking back at Look AHEAD

The most recent follow-up data from the Action for Health in Diabetes (Look AHEAD) study compared cardiovascular event rates among patients randomized to either an intensive lifestyle intervention or a diabetes support and education program. Analysis showed that the lifestyle intervention was associated with significantly more weight loss (–4.7% vs. –1.1% at 4 years, P less than .001), and with a more favorable change in fitness levels, hemoglobin A_1c, systolic blood pressure, high-density lipoprotein cholesterol levels, and triglyceride levels (P less than .001 for all comparisons) (Arch. Intern. Med. 2010;170:1566-75).

However, in September 2012, the National Institutes of Health, acting on the advice of the trial’s data and safety monitoring team, halted the lifestyle intervention because the primary endpoint of reduction in cardiovascular events had not been reached and would be unlikely to do so in the 2 years remaining in the study.

Although the trial failed to meet the cardiovascular endpoint, there was no evidence of harm, and patients who were randomized to the intervention had reduced need for diabetes medications, less sleep apnea, and increases in both physical mobility and quality of life.

"In data that are still under analysis and not yet published, I think we are going to see that there was some benefit on microvascular complications," Dr. Bantle said.

Choose procedures wisely

If lifestyle interventions are not sufficient, bariatric surgery may be helpful, Dr. Bantle said. Procedures commonly used in the United States include laparoscopic gastric banding, Roux-en-Y gastric bypass, and increasingly, sleeve gastrectomy and biliopancreatic diversion with duodenal switch.

The latter procedure is similar to a jejunoileal bypass, an early type of bariatric surgery that is no longer performed due to the high complication rate. Biliopancreatic diversion with duodenal switch involves division of the stomach and creation of a small gastric pouch that is drained with a loop of intestine attached downward to the ileum toward its head, so that biliary and pancreatic drainage occurs through the small intestine before the digestive juices meet up with food for digestion and absorption toward the end of the intestinal tract.

"I think this procedure is a really bad idea; it’s too much like a jejunoileal bypass with anastomosis, and I advise all my patients who are considering bariatric surgery to decline the option to pursue this procedure," he said.

Evidence favors surgery

Reviewing the evidence, Dr. Bantle pointed to a 2005 meta-analysis of 147 studies of bariatric surgery for obesity, which showed a mean 30.2-kg weight loss at 12 months and 34.8-kg loss after 36 months in patients who had a gastric banding procedure, compared with 43.5 kg and 41.5 kg, respectively, for gastric bypass, and 51.9 kg and 53.1 kg for those who had surgery with a duodenal switch procedure (Ann. Intern. Med. 2005;142:547-59).

The study also showed, however, that the rate of adverse events, including reflux, vomiting, dysphagia, and dumping syndrome, was markedly higher for patients who underwent a duodenal switch, at 37.7%, compared with 7.0% for gastric banding and 16.9% for gastric bypass.

A 2007 Swedish study also saw a reduction in mortality at a mean of 10.9 years of follow-up among 2,010 obese patients who underwent bariatric surgery compared with 2,037 patients who received standard medical management. The hazard ratio for death in the surgical patients was 0.76 (P = .04). The most common causes of death were myocardial infarction, which occurred in 13 surgical patients and 25 controls, and cancer, which occurred in 29 surgical patients and 47 controls (N. Engl. J. Med. 2007;357:741-52).

Similarly, a retrospective cohort study comparing 7,925 obese people who underwent gastric bypass surgery with the same number of obese controls matched by age, gender, and BMI showed that after a mean follow-up of 7.1 years, adjusted mortality for surgical patients was 37.6 per 10,000 person-years, compared with 57.1 per 10,000 for controls, a relative difference of 40%. Additionally, diabetes-specific mortality declined by 92% in the gastric bypass patients (N. Engl. J. Med. 2007;357:753-61).

Following surgery, it is important to ensure that patients have a protein intake of 60-120 g daily, and if they have undergone gastric bypass or duodenal switch procedures their diet should be supplemented with a multivitamin containing folate, thiamine, iron, vitamin B₁₂, calcium, and vitamin D, Dr. Bantle said.

"I would suggest that the earlier the surgery is done, the better. Remission of diabetes is predicted by short duration of diabetes, need for few diabetes medications, and high postprandial C-peptide, so if a patient is considering [bariatric surgery], I typically get a postprandial C-peptide and use that to counsel them about whether or not they’re likely to have remission of diabetes after the procedure," he concluded.

Dr. Bantle reported having no financial disclosures.

Bariatric surgery can significantly reduce the need for insulin and can even induce complete remission of type 2 diabetes mellitus, but some forms of the procedure pose too much risk and should be shunned, said a diabetes specialist at the annual advanced postgraduate course held by the American Diabetes Association.

Depending on the type of procedure, weight loss in the first year following bariatric surgery can range from about 30 kg to more than 50 kg, and the surgery can reduce the risk of mortality for formerly obese patients by about 25%, said Dr. John Bantle, professor of medicine and director of the division of endocrinology and diabetes at the University of Minnesota in Minneapolis.

Bariatric surgery should be considered in type 2 diabetic patients with a body mass index greater than 35 kg/m², and may also benefit patients with a BMI of 30-35, although there is not enough evidence to support the latter assertion, Dr. Bantle said.

"I would choose laparoscopic gastric bypass as the procedure to recommend. I think laparoscopic gastric banding doesn’t have enough efficacy, and duodenal switch has too many complications," he said.

Looking back at Look AHEAD

The most recent follow-up data from the Action for Health in Diabetes (Look AHEAD) study compared cardiovascular event rates among patients randomized to either an intensive lifestyle intervention or a diabetes support and education program. Analysis showed that the lifestyle intervention was associated with significantly more weight loss (–4.7% vs. –1.1% at 4 years, P less than .001), and with a more favorable change in fitness levels, hemoglobin A_1c, systolic blood pressure, high-density lipoprotein cholesterol levels, and triglyceride levels (P less than .001 for all comparisons) (Arch. Intern. Med. 2010;170:1566-75).

However, in September 2012, the National Institutes of Health, acting on the advice of the trial’s data and safety monitoring team, halted the lifestyle intervention because the primary endpoint of reduction in cardiovascular events had not been reached and would be unlikely to do so in the 2 years remaining in the study.

Although the trial failed to meet the cardiovascular endpoint, there was no evidence of harm, and patients who were randomized to the intervention had reduced need for diabetes medications, less sleep apnea, and increases in both physical mobility and quality of life.

"In data that are still under analysis and not yet published, I think we are going to see that there was some benefit on microvascular complications," Dr. Bantle said.

Choose procedures wisely

If lifestyle interventions are not sufficient, bariatric surgery may be helpful, Dr. Bantle said. Procedures commonly used in the United States include laparoscopic gastric banding, Roux-en-Y gastric bypass, and increasingly, sleeve gastrectomy and biliopancreatic diversion with duodenal switch.

The latter procedure is similar to a jejunoileal bypass, an early type of bariatric surgery that is no longer performed due to the high complication rate. Biliopancreatic diversion with duodenal switch involves division of the stomach and creation of a small gastric pouch that is drained with a loop of intestine attached downward to the ileum toward its head, so that biliary and pancreatic drainage occurs through the small intestine before the digestive juices meet up with food for digestion and absorption toward the end of the intestinal tract.

"I think this procedure is a really bad idea; it’s too much like a jejunoileal bypass with anastomosis, and I advise all my patients who are considering bariatric surgery to decline the option to pursue this procedure," he said.

Evidence favors surgery

Reviewing the evidence, Dr. Bantle pointed to a 2005 meta-analysis of 147 studies of bariatric surgery for obesity, which showed a mean 30.2-kg weight loss at 12 months and 34.8-kg loss after 36 months in patients who had a gastric banding procedure, compared with 43.5 kg and 41.5 kg, respectively, for gastric bypass, and 51.9 kg and 53.1 kg for those who had surgery with a duodenal switch procedure (Ann. Intern. Med. 2005;142:547-59).

The study also showed, however, that the rate of adverse events, including reflux, vomiting, dysphagia, and dumping syndrome, was markedly higher for patients who underwent a duodenal switch, at 37.7%, compared with 7.0% for gastric banding and 16.9% for gastric bypass.

A 2007 Swedish study also saw a reduction in mortality at a mean of 10.9 years of follow-up among 2,010 obese patients who underwent bariatric surgery compared with 2,037 patients who received standard medical management. The hazard ratio for death in the surgical patients was 0.76 (P = .04). The most common causes of death were myocardial infarction, which occurred in 13 surgical patients and 25 controls, and cancer, which occurred in 29 surgical patients and 47 controls (N. Engl. J. Med. 2007;357:741-52).

Similarly, a retrospective cohort study comparing 7,925 obese people who underwent gastric bypass surgery with the same number of obese controls matched by age, gender, and BMI showed that after a mean follow-up of 7.1 years, adjusted mortality for surgical patients was 37.6 per 10,000 person-years, compared with 57.1 per 10,000 for controls, a relative difference of 40%. Additionally, diabetes-specific mortality declined by 92% in the gastric bypass patients (N. Engl. J. Med. 2007;357:753-61).

Following surgery, it is important to ensure that patients have a protein intake of 60-120 g daily, and if they have undergone gastric bypass or duodenal switch procedures their diet should be supplemented with a multivitamin containing folate, thiamine, iron, vitamin B₁₂, calcium, and vitamin D, Dr. Bantle said.

"I would suggest that the earlier the surgery is done, the better. Remission of diabetes is predicted by short duration of diabetes, need for few diabetes medications, and high postprandial C-peptide, so if a patient is considering [bariatric surgery], I typically get a postprandial C-peptide and use that to counsel them about whether or not they’re likely to have remission of diabetes after the procedure," he concluded.

Dr. Bantle reported having no financial disclosures.

SAN JUAN, P.R.  – Noninvasive ventilation can be safely initiated and monitored on a general medical ward, taking some of the pressure off intensive care units, investigators reported at the Critical Care Congress, sponsored by the Society for Critical Care Medicine.

A retrospective study comparing outcomes for patients started on noninvasive ventilation (NIV) on general floors with those of patients put on NIV in the ICU showed that patients on the general wards were less likely to need intubation and had a shorter length of stay, but with mortality similar to that of ICU-treated patients, reported Dr. Edison Gavilanes, a resident in internal medicine at New York Hospital Queens.

If the patients started on noninvasive ventilation have community-acquired pneumonia (CAP), however, there is a high likelihood that they will eventually need to be intubated, cautioned Dr. Anwar Murad, an internal medicine resident at McGill University Health Centre, Montreal.

"Even though current evidence does not support NIV use in CAP, our data demonstrate that it is commonly employed in critical care units," Dr. Murad said in a poster presentation.

NIV in general

The New York researchers noted that, although current guidelines recommend that patients be started on NIV in the ICU and transferred to a step-down unit when they are stable, there are "little data to suggest that NIV on general wards is unsafe or that it could have an effect on mortality."

To see whether it was safe to start patients on NIV in general wards, they took a retrospective look at the records of 647 patients treated with NIV in 2011, collecting both clinical and demographic parameters as well as physiologic measures, including pH levels, carbon dioxide partial pressure (pCO₂), oxygen partial pressure (pO₂), and serum bicarbonate.

They found that, compared with the 184 patients in whom NIV was initiated in the ICU, the group of 463 patients started on NIV on the general wards had a higher mean age (77.8 vs. 73.1 years), more females than males (56.6% vs. 41.8%), higher mean pCO₂ (51.4 vs. 42.9 mm Hg; P less than .0001), and was more likely to have respiratory failure from pulmonary causes rather than heart failure (69.8% vs. 51.1%; P less than .007).

Patients in the general wards had a significantly lower incidence of intubation (14.5% vs. 47.3%; P less than .0001) and shorter length of stay (11.6 vs. 15.9 days; P = .0001), Dr. Gavilanes reported.

There was no significant difference in mortality.

Variables associated with failure of an NIV trial on the floor and transfer to the ICU included the presence of metabolic acidosis, vasopressor requirement, and need for intubation. Patients who required transfer to the ICU had a higher mortality rate than did those who did not require it (62.9% vs. 27.6%; P less than .0001).

The investigators noted that "93% of the patients in whom NIV was started on the general medical wards did not require eventual ICU transfer or have increased mortality. However, patients with hemodynamic instability and metabolic acidosis can fail NIV and might benefit from ICU level monitoring."

NIV common for CAP

The Canadian researchers examined whether NIV was safe in patients with community-acquired pneumonia.

"Despite a lack of data supporting its use, NIV is commonly used in the management of patients with CAP. It is unclear which patients benefit from NIV and avoid endotracheal intubation," Dr. Murad said.

He and his associates conducted a retrospective cohort study of records on patients admitted to three critical care units from 2007 to 2012 with a diagnosis of CAP who were started on either noninvasive or invasive ventilation.

They identified 229 patients – 93 were intubated and 136 were started on NIV. Patients on NIV tended to be older (median age, 73 vs. 68 years), but there were no significant differences in baseline characteristics.

There were no significant differences in mortality for the overall cohort (46% vs. 33%), cardiac care unit length of stay (9 days in each group), or hospital length of stay (20 days vs. 17 days).

However, 101 (74%) patients failed NIV and required endotracheal intubation. Of the 101 patients in the NIV failure group, 50 (49.5%) required vasopressors, compared with 4 of the 35 patients (11.4%) who were successfully maintained on NIV.

As in the study by Dr. Gavilanes and his colleagues, there were significantly more deaths among patients who failed NIV (53 vs. 8; P = .002), as well as hemodynamic instability (54 vs. 8; P less than .001), and lactic acidosis (31 vs. 2; P =.003).

"Patients with CAP treated with NIV have a high likelihood of requiring intubation and developing significant complications. Patients started on NIV for severe CAP should be considered for early intubation if found to require vasopressor or have persistent hypoxemia/acidosis," Dr. Murad said.

Both studies were internally funded. Dr. Gavilanes and Dr. Murad each reported having no financial disclosures.

imnews@elsevier.com

SAN JUAN, P.R.  – Noninvasive ventilation can be safely initiated and monitored on a general medical ward, taking some of the pressure off intensive care units, investigators reported at the Critical Care Congress, sponsored by the Society for Critical Care Medicine.

A retrospective study comparing outcomes for patients started on noninvasive ventilation (NIV) on general floors with those of patients put on NIV in the ICU showed that patients on the general wards were less likely to need intubation and had a shorter length of stay, but with mortality similar to that of ICU-treated patients, reported Dr. Edison Gavilanes, a resident in internal medicine at New York Hospital Queens.

If the patients started on noninvasive ventilation have community-acquired pneumonia (CAP), however, there is a high likelihood that they will eventually need to be intubated, cautioned Dr. Anwar Murad, an internal medicine resident at McGill University Health Centre, Montreal.

"Even though current evidence does not support NIV use in CAP, our data demonstrate that it is commonly employed in critical care units," Dr. Murad said in a poster presentation.

NIV in general

The New York researchers noted that, although current guidelines recommend that patients be started on NIV in the ICU and transferred to a step-down unit when they are stable, there are "little data to suggest that NIV on general wards is unsafe or that it could have an effect on mortality."

To see whether it was safe to start patients on NIV in general wards, they took a retrospective look at the records of 647 patients treated with NIV in 2011, collecting both clinical and demographic parameters as well as physiologic measures, including pH levels, carbon dioxide partial pressure (pCO₂), oxygen partial pressure (pO₂), and serum bicarbonate.

They found that, compared with the 184 patients in whom NIV was initiated in the ICU, the group of 463 patients started on NIV on the general wards had a higher mean age (77.8 vs. 73.1 years), more females than males (56.6% vs. 41.8%), higher mean pCO₂ (51.4 vs. 42.9 mm Hg; P less than .0001), and was more likely to have respiratory failure from pulmonary causes rather than heart failure (69.8% vs. 51.1%; P less than .007).

Patients in the general wards had a significantly lower incidence of intubation (14.5% vs. 47.3%; P less than .0001) and shorter length of stay (11.6 vs. 15.9 days; P = .0001), Dr. Gavilanes reported.

There was no significant difference in mortality.

Variables associated with failure of an NIV trial on the floor and transfer to the ICU included the presence of metabolic acidosis, vasopressor requirement, and need for intubation. Patients who required transfer to the ICU had a higher mortality rate than did those who did not require it (62.9% vs. 27.6%; P less than .0001).

The investigators noted that "93% of the patients in whom NIV was started on the general medical wards did not require eventual ICU transfer or have increased mortality. However, patients with hemodynamic instability and metabolic acidosis can fail NIV and might benefit from ICU level monitoring."

NIV common for CAP

The Canadian researchers examined whether NIV was safe in patients with community-acquired pneumonia.

"Despite a lack of data supporting its use, NIV is commonly used in the management of patients with CAP. It is unclear which patients benefit from NIV and avoid endotracheal intubation," Dr. Murad said.

He and his associates conducted a retrospective cohort study of records on patients admitted to three critical care units from 2007 to 2012 with a diagnosis of CAP who were started on either noninvasive or invasive ventilation.

They identified 229 patients – 93 were intubated and 136 were started on NIV. Patients on NIV tended to be older (median age, 73 vs. 68 years), but there were no significant differences in baseline characteristics.

There were no significant differences in mortality for the overall cohort (46% vs. 33%), cardiac care unit length of stay (9 days in each group), or hospital length of stay (20 days vs. 17 days).

However, 101 (74%) patients failed NIV and required endotracheal intubation. Of the 101 patients in the NIV failure group, 50 (49.5%) required vasopressors, compared with 4 of the 35 patients (11.4%) who were successfully maintained on NIV.

As in the study by Dr. Gavilanes and his colleagues, there were significantly more deaths among patients who failed NIV (53 vs. 8; P = .002), as well as hemodynamic instability (54 vs. 8; P less than .001), and lactic acidosis (31 vs. 2; P =.003).

"Patients with CAP treated with NIV have a high likelihood of requiring intubation and developing significant complications. Patients started on NIV for severe CAP should be considered for early intubation if found to require vasopressor or have persistent hypoxemia/acidosis," Dr. Murad said.

Both studies were internally funded. Dr. Gavilanes and Dr. Murad each reported having no financial disclosures.

imnews@elsevier.com

SAN JUAN, P.R.  – Noninvasive ventilation can be safely initiated and monitored on a general medical ward, taking some of the pressure off intensive care units, investigators reported at the Critical Care Congress, sponsored by the Society for Critical Care Medicine.

A retrospective study comparing outcomes for patients started on noninvasive ventilation (NIV) on general floors with those of patients put on NIV in the ICU showed that patients on the general wards were less likely to need intubation and had a shorter length of stay, but with mortality similar to that of ICU-treated patients, reported Dr. Edison Gavilanes, a resident in internal medicine at New York Hospital Queens.

If the patients started on noninvasive ventilation have community-acquired pneumonia (CAP), however, there is a high likelihood that they will eventually need to be intubated, cautioned Dr. Anwar Murad, an internal medicine resident at McGill University Health Centre, Montreal.

"Even though current evidence does not support NIV use in CAP, our data demonstrate that it is commonly employed in critical care units," Dr. Murad said in a poster presentation.

NIV in general

The New York researchers noted that, although current guidelines recommend that patients be started on NIV in the ICU and transferred to a step-down unit when they are stable, there are "little data to suggest that NIV on general wards is unsafe or that it could have an effect on mortality."

To see whether it was safe to start patients on NIV in general wards, they took a retrospective look at the records of 647 patients treated with NIV in 2011, collecting both clinical and demographic parameters as well as physiologic measures, including pH levels, carbon dioxide partial pressure (pCO₂), oxygen partial pressure (pO₂), and serum bicarbonate.

They found that, compared with the 184 patients in whom NIV was initiated in the ICU, the group of 463 patients started on NIV on the general wards had a higher mean age (77.8 vs. 73.1 years), more females than males (56.6% vs. 41.8%), higher mean pCO₂ (51.4 vs. 42.9 mm Hg; P less than .0001), and was more likely to have respiratory failure from pulmonary causes rather than heart failure (69.8% vs. 51.1%; P less than .007).

Patients in the general wards had a significantly lower incidence of intubation (14.5% vs. 47.3%; P less than .0001) and shorter length of stay (11.6 vs. 15.9 days; P = .0001), Dr. Gavilanes reported.

There was no significant difference in mortality.

Variables associated with failure of an NIV trial on the floor and transfer to the ICU included the presence of metabolic acidosis, vasopressor requirement, and need for intubation. Patients who required transfer to the ICU had a higher mortality rate than did those who did not require it (62.9% vs. 27.6%; P less than .0001).

The investigators noted that "93% of the patients in whom NIV was started on the general medical wards did not require eventual ICU transfer or have increased mortality. However, patients with hemodynamic instability and metabolic acidosis can fail NIV and might benefit from ICU level monitoring."

NIV common for CAP

The Canadian researchers examined whether NIV was safe in patients with community-acquired pneumonia.

"Despite a lack of data supporting its use, NIV is commonly used in the management of patients with CAP. It is unclear which patients benefit from NIV and avoid endotracheal intubation," Dr. Murad said.

He and his associates conducted a retrospective cohort study of records on patients admitted to three critical care units from 2007 to 2012 with a diagnosis of CAP who were started on either noninvasive or invasive ventilation.

They identified 229 patients – 93 were intubated and 136 were started on NIV. Patients on NIV tended to be older (median age, 73 vs. 68 years), but there were no significant differences in baseline characteristics.

There were no significant differences in mortality for the overall cohort (46% vs. 33%), cardiac care unit length of stay (9 days in each group), or hospital length of stay (20 days vs. 17 days).

However, 101 (74%) patients failed NIV and required endotracheal intubation. Of the 101 patients in the NIV failure group, 50 (49.5%) required vasopressors, compared with 4 of the 35 patients (11.4%) who were successfully maintained on NIV.

As in the study by Dr. Gavilanes and his colleagues, there were significantly more deaths among patients who failed NIV (53 vs. 8; P = .002), as well as hemodynamic instability (54 vs. 8; P less than .001), and lactic acidosis (31 vs. 2; P =.003).

"Patients with CAP treated with NIV have a high likelihood of requiring intubation and developing significant complications. Patients started on NIV for severe CAP should be considered for early intubation if found to require vasopressor or have persistent hypoxemia/acidosis," Dr. Murad said.

Both studies were internally funded. Dr. Gavilanes and Dr. Murad each reported having no financial disclosures.

imnews@elsevier.com

SAN JUAN, P.R. – Beta-2 agonists neither reduce mortality nor shorten hospital stays for patients with acute lung injury or acute respiratory distress syndrome, investigators reported at the Critical Care Congress.

A systematic review and meta-analysis showed that in randomized controlled trials, patients with acute lung injury (ALI) or acute respiratory distress syndrome (ARDS) who received either intravenous or aerosolized beta-2 agonists did not have significantly lower in-hospital or 28-day mortality than that of similar patients who did not receive the drugs.

"The current evidence discourages the use of beta-2 agonists among ALI/ARDS patients," Dr. Balwinder Singh, a research fellow in pulmonary and critical care medicine at the Mayo Clinic in Rochester, Minn., and his colleagues wrote in a poster.

In one of the studies included in the meta-analysis – the Beta-Agonist Lung Injury Trial (BALTI), published in 2006 – investigators in the United Kingdom found that patients randomly assigned to receive intravenous albuterol (salbutamol in the United Kingdom) had significantly lower amounts of lung water and plateau airway pressures than did controls (Am. J. Respir. Crit. Care Med. 173;3:281-7). This finding, plus evidence from preclinical studies, prompted other researchers to investigate whether beta-2 agonists could improve survival and other important outcomes.

In a 2011 study, investigators from the ARDS Clinical Trials Network noted that the rationale for the use of beta-2 adrenergic receptor agonists in patients with ALI/ARDS is that they had been shown to accelerate the resolution of pulmonary edema in preclinical studies and in a single controlled trial, and that "decreased resolution of alveolar edema is associated with increased mortality" (Am. J. Respir. Crit. Care Med. 2011;184:561-68).

To see whether those ideas hold water, Dr. Singh and his colleagues trolled the medical literature for randomized controlled trials that used a beta-2 agonist for ALI.

They reviewed 204 total studies, settling on three randomized controlled trials, including the two aforementioned studies and the BALTI-2 trial (Lancet 2012;379:229-35). The studies showed either mortality rates or ventilator-free days for patients on beta-2 agonists, or both. The studies followed a total of 646 patients, of whom 334 (51.7%) were prescribed a beta-2 agonist.

The beta-2 agonists were not associated with a significant decrease in 28-day mortality (relative risk, 1.04; 95% confidence interval, 0.50-2.16) or in-hospital mortality (RR, 1.22; CI, 0.95-1.56).

In addition, patients who received a beta-2 agonist had markedly fewer ventilator-free days, with a mean difference of –2.20 days (CI, –2.41 to –1.99).

The conclusion of Dr. Singh and his colleagues – that the evidence weighs against the use of beta-2 agonists in ALI/ARDS – echoes that of the BALTI-2 researchers, who wrote, "Findings from this multicentre trial provide evidence that intravenous salbutamol in the early course of ARDS was poorly tolerated, is unlikely to be beneficial, and could worsen outcomes. Routine use of beta-2 agonist therapy in mechanically ventilated patients with ARDS cannot be recommended."

The Critical Care Congress was sponsored by the Society for Critical Care Medicine.

The study was internally funded. Dr. Singh reported having no financial disclosures.

SAN JUAN, P.R. – Beta-2 agonists neither reduce mortality nor shorten hospital stays for patients with acute lung injury or acute respiratory distress syndrome, investigators reported at the Critical Care Congress.

A systematic review and meta-analysis showed that in randomized controlled trials, patients with acute lung injury (ALI) or acute respiratory distress syndrome (ARDS) who received either intravenous or aerosolized beta-2 agonists did not have significantly lower in-hospital or 28-day mortality than that of similar patients who did not receive the drugs.

"The current evidence discourages the use of beta-2 agonists among ALI/ARDS patients," Dr. Balwinder Singh, a research fellow in pulmonary and critical care medicine at the Mayo Clinic in Rochester, Minn., and his colleagues wrote in a poster.

In one of the studies included in the meta-analysis – the Beta-Agonist Lung Injury Trial (BALTI), published in 2006 – investigators in the United Kingdom found that patients randomly assigned to receive intravenous albuterol (salbutamol in the United Kingdom) had significantly lower amounts of lung water and plateau airway pressures than did controls (Am. J. Respir. Crit. Care Med. 173;3:281-7). This finding, plus evidence from preclinical studies, prompted other researchers to investigate whether beta-2 agonists could improve survival and other important outcomes.

In a 2011 study, investigators from the ARDS Clinical Trials Network noted that the rationale for the use of beta-2 adrenergic receptor agonists in patients with ALI/ARDS is that they had been shown to accelerate the resolution of pulmonary edema in preclinical studies and in a single controlled trial, and that "decreased resolution of alveolar edema is associated with increased mortality" (Am. J. Respir. Crit. Care Med. 2011;184:561-68).

To see whether those ideas hold water, Dr. Singh and his colleagues trolled the medical literature for randomized controlled trials that used a beta-2 agonist for ALI.

They reviewed 204 total studies, settling on three randomized controlled trials, including the two aforementioned studies and the BALTI-2 trial (Lancet 2012;379:229-35). The studies showed either mortality rates or ventilator-free days for patients on beta-2 agonists, or both. The studies followed a total of 646 patients, of whom 334 (51.7%) were prescribed a beta-2 agonist.

The beta-2 agonists were not associated with a significant decrease in 28-day mortality (relative risk, 1.04; 95% confidence interval, 0.50-2.16) or in-hospital mortality (RR, 1.22; CI, 0.95-1.56).

In addition, patients who received a beta-2 agonist had markedly fewer ventilator-free days, with a mean difference of –2.20 days (CI, –2.41 to –1.99).

The conclusion of Dr. Singh and his colleagues – that the evidence weighs against the use of beta-2 agonists in ALI/ARDS – echoes that of the BALTI-2 researchers, who wrote, "Findings from this multicentre trial provide evidence that intravenous salbutamol in the early course of ARDS was poorly tolerated, is unlikely to be beneficial, and could worsen outcomes. Routine use of beta-2 agonist therapy in mechanically ventilated patients with ARDS cannot be recommended."

The Critical Care Congress was sponsored by the Society for Critical Care Medicine.

The study was internally funded. Dr. Singh reported having no financial disclosures.

SAN JUAN, P.R. – Beta-2 agonists neither reduce mortality nor shorten hospital stays for patients with acute lung injury or acute respiratory distress syndrome, investigators reported at the Critical Care Congress.

A systematic review and meta-analysis showed that in randomized controlled trials, patients with acute lung injury (ALI) or acute respiratory distress syndrome (ARDS) who received either intravenous or aerosolized beta-2 agonists did not have significantly lower in-hospital or 28-day mortality than that of similar patients who did not receive the drugs.

"The current evidence discourages the use of beta-2 agonists among ALI/ARDS patients," Dr. Balwinder Singh, a research fellow in pulmonary and critical care medicine at the Mayo Clinic in Rochester, Minn., and his colleagues wrote in a poster.

In one of the studies included in the meta-analysis – the Beta-Agonist Lung Injury Trial (BALTI), published in 2006 – investigators in the United Kingdom found that patients randomly assigned to receive intravenous albuterol (salbutamol in the United Kingdom) had significantly lower amounts of lung water and plateau airway pressures than did controls (Am. J. Respir. Crit. Care Med. 173;3:281-7). This finding, plus evidence from preclinical studies, prompted other researchers to investigate whether beta-2 agonists could improve survival and other important outcomes.

In a 2011 study, investigators from the ARDS Clinical Trials Network noted that the rationale for the use of beta-2 adrenergic receptor agonists in patients with ALI/ARDS is that they had been shown to accelerate the resolution of pulmonary edema in preclinical studies and in a single controlled trial, and that "decreased resolution of alveolar edema is associated with increased mortality" (Am. J. Respir. Crit. Care Med. 2011;184:561-68).

To see whether those ideas hold water, Dr. Singh and his colleagues trolled the medical literature for randomized controlled trials that used a beta-2 agonist for ALI.

They reviewed 204 total studies, settling on three randomized controlled trials, including the two aforementioned studies and the BALTI-2 trial (Lancet 2012;379:229-35). The studies showed either mortality rates or ventilator-free days for patients on beta-2 agonists, or both. The studies followed a total of 646 patients, of whom 334 (51.7%) were prescribed a beta-2 agonist.

The beta-2 agonists were not associated with a significant decrease in 28-day mortality (relative risk, 1.04; 95% confidence interval, 0.50-2.16) or in-hospital mortality (RR, 1.22; CI, 0.95-1.56).

In addition, patients who received a beta-2 agonist had markedly fewer ventilator-free days, with a mean difference of –2.20 days (CI, –2.41 to –1.99).

The conclusion of Dr. Singh and his colleagues – that the evidence weighs against the use of beta-2 agonists in ALI/ARDS – echoes that of the BALTI-2 researchers, who wrote, "Findings from this multicentre trial provide evidence that intravenous salbutamol in the early course of ARDS was poorly tolerated, is unlikely to be beneficial, and could worsen outcomes. Routine use of beta-2 agonist therapy in mechanically ventilated patients with ARDS cannot be recommended."

The Critical Care Congress was sponsored by the Society for Critical Care Medicine.

The study was internally funded. Dr. Singh reported having no financial disclosures.

ATLANTA – It doesn’t get more personal than this: genetic studies of individual patients can predict who is at increased risk for treatment-related toxicity or death, reported investigators at the annual meeting of the American Society of Hematology.

For example, a single nucleotide polymorphism (SNP) in the Wilms tumor gene (WT1) appears to predict lower risk for treatment-related mortality in children of African American and Asian ancestry with acute myeloid leukemia, reported Dr. Phoenix A. Ho from the University of Washington and Fred Hutchinson Cancer Center, both in Seattle.

Other recently identified polymorphisms appear to increase the risk of cardiotoxicity from exposure to anthracyclines in chemotherapy regimens, reported Dr. Smita Bhatia from the City of Hope Comprehensive Cancer Center in Duarte, Calif.

Protection from toxicity

Dr. Ho and his colleagues had previously identified mutations in the exon 7 region of WT1, a tumor suppressor and transcription factor gene that is over-expressed in an estimated 81% of AML cells compared with normal hematopoietic cells. Mutations in WT1 found in about 8% of children with AML are associated with worse prognosis, Dr. Ho said.

But during their investigation of mutations, the researchers also found apparently favorable single-nucleotide polymorphisms (SNPs), specifically a normal variant labeled rs16754, in cancer samples from children with AML or myelodysplastic syndrome enrolled in the Children’s Oncology Group CCG-2961 trial comparing combination chemotherapy with or without bone marrow transplantation.

"Normally, in our work looking at changes in leukemia DNA, we ignore these polymorphisms, but we were surprised to find that patients that carry this SNP, which is present in about one-third of the American population, had a significantly improved overall survival," Dr. Ho said at a media briefing.

They found that the SNP was present in 25% of white patients, 21% of African Americans, 34% of Hispanics, and 53% of Asians in CCG-2961.

When they then looked at differences in toxicity-related deaths by ethnic group and SNP status, they found that the African American patients who were positive for rs16754 had no toxicity-related deaths, compared with 25% of African American patients who were SNP negative. Among patients of Asian background, the difference was even more pronounced, with none of the SNP-positive patients dying from treatment toxicity, compared with 43% of Asians who were SNP-negative.

Although the numbers of patients were small, there was evidence hinting that treatment-related mortality was higher among SNP-negative patients assigned to an experimental arm with a consolidation regimen containing the then-investigational agent fludarabine, Dr. Ho said.

He and his colleagues plan to validate the ethnicity-specific associations they found, and explore biologic mechanisms for the association of WT1 SNPs and patient outcomes, Dr. Ho said.

Heart failure markers

Dr. Bhatia presented data from a study led by Dr. Saro Armenian, a researcher in her laboratory. The investigators looked at polymorphisms that may contribute to anthracycline-related heart failure 1 or more years after a hematopoietic cell transplant (HCT).

They investigated candidate genes for anthracycline metabolism, iron homeostasis, antioxidant defense, and myocardial remodeling in a nested case-control study of all transplant patients at City of Hope from 1988 through 2008, including 77 HCT survivors with heart failure, and 178 without it.

They found that in addition to risk factors known to be associated with heart failure in transplant survivors such as female gender (odds ratio [OR], 3.0; P less than .01), radiation to the chest (OR, 5.6; P less than .05), and hypertension (OR, 3.5; P less than .05), three SNPs were significantly associated with risk. The suspect SNPs were in genes for the multidrug resistant protein (MRP2 –rs8187710; OR, 3.7; P less than .05), nicotinamide adenine dinucleotide phosphate (NADPH) oxidase subunit (RAC2 –rs13058338; OR, 3.0; P less than .01), and hemochromatosis (HFE2-rs1799945; OR, 2.4; P less than .05).

In multivariate analysis controlling for age at transplant, ethnicity, donor source, anthracycline dose, and follow-up time, the investigators saw that combinations of the risk factors increased the likelihood that survivors would develop heart failure. For example, females with two or more of the SNPs had a 17-fold greater risk (P less than .01), and males with two or more SNPs had a fivefold higher risk (P less than .05).

"There is biological plausibility to the genes that we have identified, and we are pretty certain this conglomeration of genes, along with the clinical factors, can predict a patient developing congestive heart failure," Dr. Bhatia said.

Dr. Ho’s and Dr. Bhatia’s studies were supported by the National Institutes of Health. Dr. Ho and Dr. Bhatia declared no relevant conflicts of interest.

ATLANTA – It doesn’t get more personal than this: genetic studies of individual patients can predict who is at increased risk for treatment-related toxicity or death, reported investigators at the annual meeting of the American Society of Hematology.

For example, a single nucleotide polymorphism (SNP) in the Wilms tumor gene (WT1) appears to predict lower risk for treatment-related mortality in children of African American and Asian ancestry with acute myeloid leukemia, reported Dr. Phoenix A. Ho from the University of Washington and Fred Hutchinson Cancer Center, both in Seattle.

Other recently identified polymorphisms appear to increase the risk of cardiotoxicity from exposure to anthracyclines in chemotherapy regimens, reported Dr. Smita Bhatia from the City of Hope Comprehensive Cancer Center in Duarte, Calif.

Protection from toxicity

Dr. Ho and his colleagues had previously identified mutations in the exon 7 region of WT1, a tumor suppressor and transcription factor gene that is over-expressed in an estimated 81% of AML cells compared with normal hematopoietic cells. Mutations in WT1 found in about 8% of children with AML are associated with worse prognosis, Dr. Ho said.

But during their investigation of mutations, the researchers also found apparently favorable single-nucleotide polymorphisms (SNPs), specifically a normal variant labeled rs16754, in cancer samples from children with AML or myelodysplastic syndrome enrolled in the Children’s Oncology Group CCG-2961 trial comparing combination chemotherapy with or without bone marrow transplantation.

"Normally, in our work looking at changes in leukemia DNA, we ignore these polymorphisms, but we were surprised to find that patients that carry this SNP, which is present in about one-third of the American population, had a significantly improved overall survival," Dr. Ho said at a media briefing.

They found that the SNP was present in 25% of white patients, 21% of African Americans, 34% of Hispanics, and 53% of Asians in CCG-2961.

When they then looked at differences in toxicity-related deaths by ethnic group and SNP status, they found that the African American patients who were positive for rs16754 had no toxicity-related deaths, compared with 25% of African American patients who were SNP negative. Among patients of Asian background, the difference was even more pronounced, with none of the SNP-positive patients dying from treatment toxicity, compared with 43% of Asians who were SNP-negative.

Although the numbers of patients were small, there was evidence hinting that treatment-related mortality was higher among SNP-negative patients assigned to an experimental arm with a consolidation regimen containing the then-investigational agent fludarabine, Dr. Ho said.

He and his colleagues plan to validate the ethnicity-specific associations they found, and explore biologic mechanisms for the association of WT1 SNPs and patient outcomes, Dr. Ho said.

Heart failure markers

Dr. Bhatia presented data from a study led by Dr. Saro Armenian, a researcher in her laboratory. The investigators looked at polymorphisms that may contribute to anthracycline-related heart failure 1 or more years after a hematopoietic cell transplant (HCT).

They investigated candidate genes for anthracycline metabolism, iron homeostasis, antioxidant defense, and myocardial remodeling in a nested case-control study of all transplant patients at City of Hope from 1988 through 2008, including 77 HCT survivors with heart failure, and 178 without it.

They found that in addition to risk factors known to be associated with heart failure in transplant survivors such as female gender (odds ratio [OR], 3.0; P less than .01), radiation to the chest (OR, 5.6; P less than .05), and hypertension (OR, 3.5; P less than .05), three SNPs were significantly associated with risk. The suspect SNPs were in genes for the multidrug resistant protein (MRP2 –rs8187710; OR, 3.7; P less than .05), nicotinamide adenine dinucleotide phosphate (NADPH) oxidase subunit (RAC2 –rs13058338; OR, 3.0; P less than .01), and hemochromatosis (HFE2-rs1799945; OR, 2.4; P less than .05).

In multivariate analysis controlling for age at transplant, ethnicity, donor source, anthracycline dose, and follow-up time, the investigators saw that combinations of the risk factors increased the likelihood that survivors would develop heart failure. For example, females with two or more of the SNPs had a 17-fold greater risk (P less than .01), and males with two or more SNPs had a fivefold higher risk (P less than .05).

"There is biological plausibility to the genes that we have identified, and we are pretty certain this conglomeration of genes, along with the clinical factors, can predict a patient developing congestive heart failure," Dr. Bhatia said.

Dr. Ho’s and Dr. Bhatia’s studies were supported by the National Institutes of Health. Dr. Ho and Dr. Bhatia declared no relevant conflicts of interest.

ATLANTA – It doesn’t get more personal than this: genetic studies of individual patients can predict who is at increased risk for treatment-related toxicity or death, reported investigators at the annual meeting of the American Society of Hematology.

For example, a single nucleotide polymorphism (SNP) in the Wilms tumor gene (WT1) appears to predict lower risk for treatment-related mortality in children of African American and Asian ancestry with acute myeloid leukemia, reported Dr. Phoenix A. Ho from the University of Washington and Fred Hutchinson Cancer Center, both in Seattle.

Other recently identified polymorphisms appear to increase the risk of cardiotoxicity from exposure to anthracyclines in chemotherapy regimens, reported Dr. Smita Bhatia from the City of Hope Comprehensive Cancer Center in Duarte, Calif.

Protection from toxicity

Dr. Ho and his colleagues had previously identified mutations in the exon 7 region of WT1, a tumor suppressor and transcription factor gene that is over-expressed in an estimated 81% of AML cells compared with normal hematopoietic cells. Mutations in WT1 found in about 8% of children with AML are associated with worse prognosis, Dr. Ho said.

But during their investigation of mutations, the researchers also found apparently favorable single-nucleotide polymorphisms (SNPs), specifically a normal variant labeled rs16754, in cancer samples from children with AML or myelodysplastic syndrome enrolled in the Children’s Oncology Group CCG-2961 trial comparing combination chemotherapy with or without bone marrow transplantation.

"Normally, in our work looking at changes in leukemia DNA, we ignore these polymorphisms, but we were surprised to find that patients that carry this SNP, which is present in about one-third of the American population, had a significantly improved overall survival," Dr. Ho said at a media briefing.

They found that the SNP was present in 25% of white patients, 21% of African Americans, 34% of Hispanics, and 53% of Asians in CCG-2961.

When they then looked at differences in toxicity-related deaths by ethnic group and SNP status, they found that the African American patients who were positive for rs16754 had no toxicity-related deaths, compared with 25% of African American patients who were SNP negative. Among patients of Asian background, the difference was even more pronounced, with none of the SNP-positive patients dying from treatment toxicity, compared with 43% of Asians who were SNP-negative.

Although the numbers of patients were small, there was evidence hinting that treatment-related mortality was higher among SNP-negative patients assigned to an experimental arm with a consolidation regimen containing the then-investigational agent fludarabine, Dr. Ho said.

He and his colleagues plan to validate the ethnicity-specific associations they found, and explore biologic mechanisms for the association of WT1 SNPs and patient outcomes, Dr. Ho said.

Heart failure markers

Dr. Bhatia presented data from a study led by Dr. Saro Armenian, a researcher in her laboratory. The investigators looked at polymorphisms that may contribute to anthracycline-related heart failure 1 or more years after a hematopoietic cell transplant (HCT).

They investigated candidate genes for anthracycline metabolism, iron homeostasis, antioxidant defense, and myocardial remodeling in a nested case-control study of all transplant patients at City of Hope from 1988 through 2008, including 77 HCT survivors with heart failure, and 178 without it.

They found that in addition to risk factors known to be associated with heart failure in transplant survivors such as female gender (odds ratio [OR], 3.0; P less than .01), radiation to the chest (OR, 5.6; P less than .05), and hypertension (OR, 3.5; P less than .05), three SNPs were significantly associated with risk. The suspect SNPs were in genes for the multidrug resistant protein (MRP2 –rs8187710; OR, 3.7; P less than .05), nicotinamide adenine dinucleotide phosphate (NADPH) oxidase subunit (RAC2 –rs13058338; OR, 3.0; P less than .01), and hemochromatosis (HFE2-rs1799945; OR, 2.4; P less than .05).

In multivariate analysis controlling for age at transplant, ethnicity, donor source, anthracycline dose, and follow-up time, the investigators saw that combinations of the risk factors increased the likelihood that survivors would develop heart failure. For example, females with two or more of the SNPs had a 17-fold greater risk (P less than .01), and males with two or more SNPs had a fivefold higher risk (P less than .05).

"There is biological plausibility to the genes that we have identified, and we are pretty certain this conglomeration of genes, along with the clinical factors, can predict a patient developing congestive heart failure," Dr. Bhatia said.

Dr. Ho’s and Dr. Bhatia’s studies were supported by the National Institutes of Health. Dr. Ho and Dr. Bhatia declared no relevant conflicts of interest.

SAN JUAN, P.R.  – Measure twice, intubate once – good thinking alongside a pilot study that suggests a simple formula based on the length of a child’s ulna can accurately predict the optimal depth for endotracheal tube insertion. The formula could save time and spare children from unnecessary radiation, investigators said at the annual congress of the Society of Critical Care Medicine.

A study of 121 orally intubated children (median age, 35.7 months) in a pediatric and a cardiothoracic intensive care unit showed that the ulna could be accurately measured with digital calipers in children with varying body habitus, as well as those with neuromuscular disease, and that a simple formula based on the measurement provides a good estimate of the best tube insertion depth, said Dr. Anne Camerlengo, a fellow in pediatric critical care at Children’s Hospital Los Angeles, and her colleagues.

"While the chest radiograph is the gold standard for determining tube placement, several nonradiographic techniques have been described, including formulas based on the patient’s weight, height, or gestational age, or the endotracheal tube diameter. However, these formulas may be less accurate for our patients with scoliosis or neuromuscular diseases that affect their height, while ulnar length is a measure that’s preserved in this population," she said in a poster session.

To see whether they could derive an accurate predictive equation for determining optimal endotracheal tube depth – 2 cm above the carina of the trachea – the investigators used chest radiographs to measure the distance from the endotracheal tube to the carina in intubated children, and recorded their ulnar length, height, and depth of endotracheal tube insertion.

They determined the optimal tube depth to be the depth of insertion plus the distance from the tube to the carina, minus 2 cm. They then plotted the optimal tube position against ulnar length, and used linear regression to calculate the following predictive equation:

Depth of endotracheal tube insertion in centimeters equals 0.75 times the ulnar length in centimeters plus 4.4.

Dr. Camerlengo said that ulnar measurements are relatively easy to make, and that the only significant difficulty occurs with children who may be frightened by the appearance of the calipers with their pointed ends.

However, "given that most of these children are reasonably well sedated, there’s not usually an issue with cooperation or finding the bony landmarks. The ulnar length is particularly useful because the bony landmarks, even in our chubbier children, we are able to palpate deeply," she said.

The investigators need to collect additional data on nasally intubated patients before they can determine whether the formula can be applied to this population.

She said that they hope to expand the analysis to include subgroups based on patient age and the presence of neuromuscular disease, and emphasized that the formulas to determine the optimal depth for both oral and nasal endotracheal tubes will need to be confirmed in a validation study.

Dr. Alexandre T. Rotta, professor of pediatrics at Case Western Reserve University and chief of pediatric critical care at Rainbow Babies and Children’s Hospital, both in Cleveland, commented that the work is promising but needs to be put to the test.

"There has been a lot of work trying to look for the magic formula of how to place an endotracheal tube. I think that key now is to see whether this will be validated in real time. They validated the formula mathematically, so the question now is does it work for various patients under various conditions, and is it reproducible with my measurement versus her measurement," Dr. Rotta said in an interview.

He was not involved in the study, but comoderated the poster discussion session at which it was presented.

The study was internally funded. Dr. Camerlengo and Dr. Rotta each reported having no disclosures.

imnews@elsevier.com

SAN JUAN, P.R.  – Measure twice, intubate once – good thinking alongside a pilot study that suggests a simple formula based on the length of a child’s ulna can accurately predict the optimal depth for endotracheal tube insertion. The formula could save time and spare children from unnecessary radiation, investigators said at the annual congress of the Society of Critical Care Medicine.

A study of 121 orally intubated children (median age, 35.7 months) in a pediatric and a cardiothoracic intensive care unit showed that the ulna could be accurately measured with digital calipers in children with varying body habitus, as well as those with neuromuscular disease, and that a simple formula based on the measurement provides a good estimate of the best tube insertion depth, said Dr. Anne Camerlengo, a fellow in pediatric critical care at Children’s Hospital Los Angeles, and her colleagues.

"While the chest radiograph is the gold standard for determining tube placement, several nonradiographic techniques have been described, including formulas based on the patient’s weight, height, or gestational age, or the endotracheal tube diameter. However, these formulas may be less accurate for our patients with scoliosis or neuromuscular diseases that affect their height, while ulnar length is a measure that’s preserved in this population," she said in a poster session.

To see whether they could derive an accurate predictive equation for determining optimal endotracheal tube depth – 2 cm above the carina of the trachea – the investigators used chest radiographs to measure the distance from the endotracheal tube to the carina in intubated children, and recorded their ulnar length, height, and depth of endotracheal tube insertion.

They determined the optimal tube depth to be the depth of insertion plus the distance from the tube to the carina, minus 2 cm. They then plotted the optimal tube position against ulnar length, and used linear regression to calculate the following predictive equation:

Depth of endotracheal tube insertion in centimeters equals 0.75 times the ulnar length in centimeters plus 4.4.

Dr. Camerlengo said that ulnar measurements are relatively easy to make, and that the only significant difficulty occurs with children who may be frightened by the appearance of the calipers with their pointed ends.

However, "given that most of these children are reasonably well sedated, there’s not usually an issue with cooperation or finding the bony landmarks. The ulnar length is particularly useful because the bony landmarks, even in our chubbier children, we are able to palpate deeply," she said.

The investigators need to collect additional data on nasally intubated patients before they can determine whether the formula can be applied to this population.

She said that they hope to expand the analysis to include subgroups based on patient age and the presence of neuromuscular disease, and emphasized that the formulas to determine the optimal depth for both oral and nasal endotracheal tubes will need to be confirmed in a validation study.

Dr. Alexandre T. Rotta, professor of pediatrics at Case Western Reserve University and chief of pediatric critical care at Rainbow Babies and Children’s Hospital, both in Cleveland, commented that the work is promising but needs to be put to the test.

"There has been a lot of work trying to look for the magic formula of how to place an endotracheal tube. I think that key now is to see whether this will be validated in real time. They validated the formula mathematically, so the question now is does it work for various patients under various conditions, and is it reproducible with my measurement versus her measurement," Dr. Rotta said in an interview.

He was not involved in the study, but comoderated the poster discussion session at which it was presented.

The study was internally funded. Dr. Camerlengo and Dr. Rotta each reported having no disclosures.

imnews@elsevier.com

SAN JUAN, P.R.  – Measure twice, intubate once – good thinking alongside a pilot study that suggests a simple formula based on the length of a child’s ulna can accurately predict the optimal depth for endotracheal tube insertion. The formula could save time and spare children from unnecessary radiation, investigators said at the annual congress of the Society of Critical Care Medicine.

A study of 121 orally intubated children (median age, 35.7 months) in a pediatric and a cardiothoracic intensive care unit showed that the ulna could be accurately measured with digital calipers in children with varying body habitus, as well as those with neuromuscular disease, and that a simple formula based on the measurement provides a good estimate of the best tube insertion depth, said Dr. Anne Camerlengo, a fellow in pediatric critical care at Children’s Hospital Los Angeles, and her colleagues.

"While the chest radiograph is the gold standard for determining tube placement, several nonradiographic techniques have been described, including formulas based on the patient’s weight, height, or gestational age, or the endotracheal tube diameter. However, these formulas may be less accurate for our patients with scoliosis or neuromuscular diseases that affect their height, while ulnar length is a measure that’s preserved in this population," she said in a poster session.

To see whether they could derive an accurate predictive equation for determining optimal endotracheal tube depth – 2 cm above the carina of the trachea – the investigators used chest radiographs to measure the distance from the endotracheal tube to the carina in intubated children, and recorded their ulnar length, height, and depth of endotracheal tube insertion.

They determined the optimal tube depth to be the depth of insertion plus the distance from the tube to the carina, minus 2 cm. They then plotted the optimal tube position against ulnar length, and used linear regression to calculate the following predictive equation:

Depth of endotracheal tube insertion in centimeters equals 0.75 times the ulnar length in centimeters plus 4.4.

Dr. Camerlengo said that ulnar measurements are relatively easy to make, and that the only significant difficulty occurs with children who may be frightened by the appearance of the calipers with their pointed ends.

However, "given that most of these children are reasonably well sedated, there’s not usually an issue with cooperation or finding the bony landmarks. The ulnar length is particularly useful because the bony landmarks, even in our chubbier children, we are able to palpate deeply," she said.

The investigators need to collect additional data on nasally intubated patients before they can determine whether the formula can be applied to this population.

She said that they hope to expand the analysis to include subgroups based on patient age and the presence of neuromuscular disease, and emphasized that the formulas to determine the optimal depth for both oral and nasal endotracheal tubes will need to be confirmed in a validation study.

Dr. Alexandre T. Rotta, professor of pediatrics at Case Western Reserve University and chief of pediatric critical care at Rainbow Babies and Children’s Hospital, both in Cleveland, commented that the work is promising but needs to be put to the test.

"There has been a lot of work trying to look for the magic formula of how to place an endotracheal tube. I think that key now is to see whether this will be validated in real time. They validated the formula mathematically, so the question now is does it work for various patients under various conditions, and is it reproducible with my measurement versus her measurement," Dr. Rotta said in an interview.

He was not involved in the study, but comoderated the poster discussion session at which it was presented.

The study was internally funded. Dr. Camerlengo and Dr. Rotta each reported having no disclosures.

imnews@elsevier.com

The incidence of acute lung injury in patients started on mechanical ventilation in the emergency department could be reduced if ED staff paid a little more attention to ventilator settings and patient monitoring, said investigators at the annual congress of the Society of Critical Care Medicine.

A retrospective study of 251 mechanically ventilated patients with severe sepsis found that tidal volumes delivered to patients were highly variable, and the high tidal volumes and other preventable causes of acute lung injury (ALI) were common in the treatment of intubated patients in the ED, reported Dr. Brian M. Fuller of the departments of emergency medicine and anesthesiology – critical care at Washington University in St. Louis, Missouri, and his colleagues.

"Inspiratory plateau pressure is monitored infrequently in the ED. Ventilator settings seem to be static, with relatively little titration, and this appears to extend to care beyond the ED as well," they wrote in a poster presentation.

"These are things you can absolutely easily intervene on with some education," Dr. Rahul Nanchal of the department of medicine at the Medical College of Wisconsin, Waukesha, said in an interview. Dr. Nanchal comoderated a poster session at which the study was presented, but was not involved in the research.

Dr. Fuller and his colleagues noted that although mechanical ventilation is commonly used in the emergency department, how it is used has not been well studied.

"Acute lung injury typically occurs early after intensive care unit admission and remains difficult to treat after onset, suggesting that prevention may be the best current therapy," they wrote.

To see just what was going on, they retrospectively reviewed records on a cohort of 251 mechanically ventilated patients with severe sepsis who presented to an urban academic emergency department with more than 95,000 annual visits.

They defined lung-protective ventilation as tidal volume (V_t) less than 8 mL/kg of ideal body weight (IBW), which had previously been established in studies of low V_t in ALI as the upper limit of V_t allowed.

They found that the median tidal volume was 8.8 mL/kg per IBW (range 7.8-10.0). Inspiratory plateau pressures were recorded for only 76 (30.3%) of patients.

In 236 patients (94%), the first tidal volume delivered was the highest, and non–lung-protective ventilation was used for a median of 230 minutes (range 0 to 354.0).

Patients were exposed to a fraction of inspired oxygen of 100%, for a median of 251 (range 148-373) minutes. In addition, 60 patients (24.8%) were exposed to the same V_t for more than 24 hours.

"High tidal volume is common in intubated ED patients, as well as other potentially injurious settings, such as prolonged exposure to high levels of oxygen," the investigators wrote.

They noted that acute lung injury occurs in about 8.8%, and progression to acute injury occurs in more than one-fourth of patients (27.5%) early after admission, at a mean of 2.1 days.

"Future trials aimed at ALI prevention should consider targeting ED mechanical ventilation in patients at high risk for ALI," they wrote.

Dr. Nanchal said that pulmonary specialists can intervene by recommending that respiratory therapists lower tidal volumes delivered to acceptable rates, monitor plateau pressures more frequently, and inform physicians if the plateau pressures are too high.

chestphysician@elsevier.com

The incidence of acute lung injury in patients started on mechanical ventilation in the emergency department could be reduced if ED staff paid a little more attention to ventilator settings and patient monitoring, said investigators at the annual congress of the Society of Critical Care Medicine.

A retrospective study of 251 mechanically ventilated patients with severe sepsis found that tidal volumes delivered to patients were highly variable, and the high tidal volumes and other preventable causes of acute lung injury (ALI) were common in the treatment of intubated patients in the ED, reported Dr. Brian M. Fuller of the departments of emergency medicine and anesthesiology – critical care at Washington University in St. Louis, Missouri, and his colleagues.

"Inspiratory plateau pressure is monitored infrequently in the ED. Ventilator settings seem to be static, with relatively little titration, and this appears to extend to care beyond the ED as well," they wrote in a poster presentation.

"These are things you can absolutely easily intervene on with some education," Dr. Rahul Nanchal of the department of medicine at the Medical College of Wisconsin, Waukesha, said in an interview. Dr. Nanchal comoderated a poster session at which the study was presented, but was not involved in the research.

Dr. Fuller and his colleagues noted that although mechanical ventilation is commonly used in the emergency department, how it is used has not been well studied.

"Acute lung injury typically occurs early after intensive care unit admission and remains difficult to treat after onset, suggesting that prevention may be the best current therapy," they wrote.

To see just what was going on, they retrospectively reviewed records on a cohort of 251 mechanically ventilated patients with severe sepsis who presented to an urban academic emergency department with more than 95,000 annual visits.

They defined lung-protective ventilation as tidal volume (V_t) less than 8 mL/kg of ideal body weight (IBW), which had previously been established in studies of low V_t in ALI as the upper limit of V_t allowed.

They found that the median tidal volume was 8.8 mL/kg per IBW (range 7.8-10.0). Inspiratory plateau pressures were recorded for only 76 (30.3%) of patients.

In 236 patients (94%), the first tidal volume delivered was the highest, and non–lung-protective ventilation was used for a median of 230 minutes (range 0 to 354.0).

Patients were exposed to a fraction of inspired oxygen of 100%, for a median of 251 (range 148-373) minutes. In addition, 60 patients (24.8%) were exposed to the same V_t for more than 24 hours.

"High tidal volume is common in intubated ED patients, as well as other potentially injurious settings, such as prolonged exposure to high levels of oxygen," the investigators wrote.

They noted that acute lung injury occurs in about 8.8%, and progression to acute injury occurs in more than one-fourth of patients (27.5%) early after admission, at a mean of 2.1 days.

"Future trials aimed at ALI prevention should consider targeting ED mechanical ventilation in patients at high risk for ALI," they wrote.

Dr. Nanchal said that pulmonary specialists can intervene by recommending that respiratory therapists lower tidal volumes delivered to acceptable rates, monitor plateau pressures more frequently, and inform physicians if the plateau pressures are too high.

chestphysician@elsevier.com

The incidence of acute lung injury in patients started on mechanical ventilation in the emergency department could be reduced if ED staff paid a little more attention to ventilator settings and patient monitoring, said investigators at the annual congress of the Society of Critical Care Medicine.

A retrospective study of 251 mechanically ventilated patients with severe sepsis found that tidal volumes delivered to patients were highly variable, and the high tidal volumes and other preventable causes of acute lung injury (ALI) were common in the treatment of intubated patients in the ED, reported Dr. Brian M. Fuller of the departments of emergency medicine and anesthesiology – critical care at Washington University in St. Louis, Missouri, and his colleagues.

"Inspiratory plateau pressure is monitored infrequently in the ED. Ventilator settings seem to be static, with relatively little titration, and this appears to extend to care beyond the ED as well," they wrote in a poster presentation.

"These are things you can absolutely easily intervene on with some education," Dr. Rahul Nanchal of the department of medicine at the Medical College of Wisconsin, Waukesha, said in an interview. Dr. Nanchal comoderated a poster session at which the study was presented, but was not involved in the research.

Dr. Fuller and his colleagues noted that although mechanical ventilation is commonly used in the emergency department, how it is used has not been well studied.

"Acute lung injury typically occurs early after intensive care unit admission and remains difficult to treat after onset, suggesting that prevention may be the best current therapy," they wrote.

To see just what was going on, they retrospectively reviewed records on a cohort of 251 mechanically ventilated patients with severe sepsis who presented to an urban academic emergency department with more than 95,000 annual visits.

They defined lung-protective ventilation as tidal volume (V_t) less than 8 mL/kg of ideal body weight (IBW), which had previously been established in studies of low V_t in ALI as the upper limit of V_t allowed.

They found that the median tidal volume was 8.8 mL/kg per IBW (range 7.8-10.0). Inspiratory plateau pressures were recorded for only 76 (30.3%) of patients.

In 236 patients (94%), the first tidal volume delivered was the highest, and non–lung-protective ventilation was used for a median of 230 minutes (range 0 to 354.0).

Patients were exposed to a fraction of inspired oxygen of 100%, for a median of 251 (range 148-373) minutes. In addition, 60 patients (24.8%) were exposed to the same V_t for more than 24 hours.

"High tidal volume is common in intubated ED patients, as well as other potentially injurious settings, such as prolonged exposure to high levels of oxygen," the investigators wrote.

They noted that acute lung injury occurs in about 8.8%, and progression to acute injury occurs in more than one-fourth of patients (27.5%) early after admission, at a mean of 2.1 days.

"Future trials aimed at ALI prevention should consider targeting ED mechanical ventilation in patients at high risk for ALI," they wrote.

Dr. Nanchal said that pulmonary specialists can intervene by recommending that respiratory therapists lower tidal volumes delivered to acceptable rates, monitor plateau pressures more frequently, and inform physicians if the plateau pressures are too high.

chestphysician@elsevier.com

One of the great ironies of our age is that many of us carry in our pockets a portal to the collected wisdom of mankind, but use it mainly to look at adorable kitten videos. For clinicians, the smartphone is a godsend, a handheld wonder that crams wheelbarrows full of manuals and even some simple diagnostic tools into a small package measuring about 7 cm x 13 cm. Whether it’s an Android, Blackberry, or iwhatever, that phone or tablet you carry around with you grants you nearly instant access to the National Library of Medicine, Food and Drug Administration, National Cancer Institute, US Pharmacopeia, and hundreds of other sites of direct and indirect relevance to your practice. Even better, there are thousands of apps, both paid-for and free, that have been designed to make challenging work lives a little easier...

*Click on the link to the left of this introduction for a PDF of the full article.

One of the great ironies of our age is that many of us carry in our pockets a portal to the collected wisdom of mankind, but use it mainly to look at adorable kitten videos. For clinicians, the smartphone is a godsend, a handheld wonder that crams wheelbarrows full of manuals and even some simple diagnostic tools into a small package measuring about 7 cm x 13 cm. Whether it’s an Android, Blackberry, or iwhatever, that phone or tablet you carry around with you grants you nearly instant access to the National Library of Medicine, Food and Drug Administration, National Cancer Institute, US Pharmacopeia, and hundreds of other sites of direct and indirect relevance to your practice. Even better, there are thousands of apps, both paid-for and free, that have been designed to make challenging work lives a little easier...

*Click on the link to the left of this introduction for a PDF of the full article.

One of the great ironies of our age is that many of us carry in our pockets a portal to the collected wisdom of mankind, but use it mainly to look at adorable kitten videos. For clinicians, the smartphone is a godsend, a handheld wonder that crams wheelbarrows full of manuals and even some simple diagnostic tools into a small package measuring about 7 cm x 13 cm. Whether it’s an Android, Blackberry, or iwhatever, that phone or tablet you carry around with you grants you nearly instant access to the National Library of Medicine, Food and Drug Administration, National Cancer Institute, US Pharmacopeia, and hundreds of other sites of direct and indirect relevance to your practice. Even better, there are thousands of apps, both paid-for and free, that have been designed to make challenging work lives a little easier...

*Click on the link to the left of this introduction for a PDF of the full article.

SAN JUAN, P.R. – The new oral anticoagulant dabigatran is the cardiologist’s darling but the intensivist’s headache and the trauma surgeon’s nightmare, suggested investigators here.

Dabigatran (Pradaxa) is a direct thrombin inhibitor approved in the United States for the reduction of risk from stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Unlike Coumadin/warfarin, dabigatran’s effects are not reversible.

Neil Osterweil/IMNG Medical Media

Pharmacists at the Scripps Mercy Hospital in San Diego evaluated prescribing patterns for dabigatran among patients in their hospital and found that 13% received it for off-label indications, a practice that has the potential for patient harm, they said at the annual meeting of the Society of Critical Care Medicine.

Of 38 patients prescribed dabigatran during their hospital stay, 33 received it for the Food and Drug Administration–approved indication but 5 (13%) received it for other, unspecified indications, reported Dr. Trevor Perry and Dr. Harminder Sikand, both clinical pharmacists at Scripps. "Prescribing was equally divided between house staff, hospitalists, and cardiologists," researchers reported (Crit. Care Med. 2012 [doi:10.1097/01.ccm.0000424500.73199.04]).

The incidence of gastrointestinal bleeding with the drug in their study was 10.5%, higher than the 6.1% rate for any gastrointestinal bleeding stated in the package insert, Dr. Perry said in an interview.

In addition, pharmacists needed to correct the dabigatran dose in 24% of patients, and dabigatran had noticeable effects on clotting parameters, with 74% of patients having an activated partial thromboplastin time (aPTT) above the upper limit of normal, and 64% of patients having an international normalized ratio (INR) above the upper limit.

This finding suggests that in these patients, the clotting assays "may be useful to determine medication adherence but not to determine the level of anticoagulation," the authors wrote in a poster presentation.

"Clinicians need to be aware of the appropriate indication for use and renal dosing of dabigatran to prevent patient harm, as only 87% of patients were prescribed dabigatran for the FDA-labeled indication," they noted.

Major heparin boost needed

In a separate study, Dr. Thomas Edrich from the department of anesthesiology, perioperative and pain medicine at Brigham & Women’s Hospital in Boston and his colleagues found that for patients scheduled for catheter-based atrial ablation procedures, those who were on dabigatran required an approximately 50% greater dose of heparin to achieve full anticoagulation for the procedure than did patients on warfarin (Crit. Care Med. 2012 [doi:10.1097/01.ccm.0000425177.10736.a4]).

Patients who had been on warfarin until 12 hours before the procedure required about 3,000-4,000 IU of heparin/hr to achieve an activated clotting time of 350 seconds, compared with about 6,500-9,000 IU/hr in patients on dabigatran, Dr. Edrich said. They studied retrospective data for 36 patients on dabigatran, 100 patients on warfarin (53 with an INR above 2.0), and 29 patients on no anticoagulation.

"The interesting finding here is that if you’ve been on dabigatran, you’re going to need twice as much heparin," he said in a poster discussion session.

Patients like it, surgeons don’t

Although patients like the convenience of oral dosing without the need for regular INR monitoring with the new anticoagulants, often they are not told that convenience may come at a very high price if there is no effective therapy to reverse the anticoagulation effect, commented Dr. Christine Toevs, a critical care surgeon at the West Penn Allegheny Health System in Pittsburgh.

"The problem is that patients aren\'t informed enough to make that choice. They understand that they’re not getting their labs drawn once a week or twice a week, and they understand that’s not a cost that they are paying. But if they fall and they have a head injury, that is a life lost, and we cannot stop it," she said during a debate on the costs of new medications.

Dr. Perry’s and Dr. Edrich’s studies were internally funded; they reported having no financial disclosures. Dr. Toevs reported having no financial disclosures.

SAN JUAN, P.R. – The new oral anticoagulant dabigatran is the cardiologist’s darling but the intensivist’s headache and the trauma surgeon’s nightmare, suggested investigators here.

Dabigatran (Pradaxa) is a direct thrombin inhibitor approved in the United States for the reduction of risk from stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Unlike Coumadin/warfarin, dabigatran’s effects are not reversible.

Neil Osterweil/IMNG Medical Media

Pharmacists at the Scripps Mercy Hospital in San Diego evaluated prescribing patterns for dabigatran among patients in their hospital and found that 13% received it for off-label indications, a practice that has the potential for patient harm, they said at the annual meeting of the Society of Critical Care Medicine.

Of 38 patients prescribed dabigatran during their hospital stay, 33 received it for the Food and Drug Administration–approved indication but 5 (13%) received it for other, unspecified indications, reported Dr. Trevor Perry and Dr. Harminder Sikand, both clinical pharmacists at Scripps. "Prescribing was equally divided between house staff, hospitalists, and cardiologists," researchers reported (Crit. Care Med. 2012 [doi:10.1097/01.ccm.0000424500.73199.04]).

The incidence of gastrointestinal bleeding with the drug in their study was 10.5%, higher than the 6.1% rate for any gastrointestinal bleeding stated in the package insert, Dr. Perry said in an interview.

In addition, pharmacists needed to correct the dabigatran dose in 24% of patients, and dabigatran had noticeable effects on clotting parameters, with 74% of patients having an activated partial thromboplastin time (aPTT) above the upper limit of normal, and 64% of patients having an international normalized ratio (INR) above the upper limit.

This finding suggests that in these patients, the clotting assays "may be useful to determine medication adherence but not to determine the level of anticoagulation," the authors wrote in a poster presentation.

"Clinicians need to be aware of the appropriate indication for use and renal dosing of dabigatran to prevent patient harm, as only 87% of patients were prescribed dabigatran for the FDA-labeled indication," they noted.

Major heparin boost needed

In a separate study, Dr. Thomas Edrich from the department of anesthesiology, perioperative and pain medicine at Brigham & Women’s Hospital in Boston and his colleagues found that for patients scheduled for catheter-based atrial ablation procedures, those who were on dabigatran required an approximately 50% greater dose of heparin to achieve full anticoagulation for the procedure than did patients on warfarin (Crit. Care Med. 2012 [doi:10.1097/01.ccm.0000425177.10736.a4]).

Patients who had been on warfarin until 12 hours before the procedure required about 3,000-4,000 IU of heparin/hr to achieve an activated clotting time of 350 seconds, compared with about 6,500-9,000 IU/hr in patients on dabigatran, Dr. Edrich said. They studied retrospective data for 36 patients on dabigatran, 100 patients on warfarin (53 with an INR above 2.0), and 29 patients on no anticoagulation.

"The interesting finding here is that if you’ve been on dabigatran, you’re going to need twice as much heparin," he said in a poster discussion session.

Patients like it, surgeons don’t

Although patients like the convenience of oral dosing without the need for regular INR monitoring with the new anticoagulants, often they are not told that convenience may come at a very high price if there is no effective therapy to reverse the anticoagulation effect, commented Dr. Christine Toevs, a critical care surgeon at the West Penn Allegheny Health System in Pittsburgh.

"The problem is that patients aren\'t informed enough to make that choice. They understand that they’re not getting their labs drawn once a week or twice a week, and they understand that’s not a cost that they are paying. But if they fall and they have a head injury, that is a life lost, and we cannot stop it," she said during a debate on the costs of new medications.

Dr. Perry’s and Dr. Edrich’s studies were internally funded; they reported having no financial disclosures. Dr. Toevs reported having no financial disclosures.

SAN JUAN, P.R. – The new oral anticoagulant dabigatran is the cardiologist’s darling but the intensivist’s headache and the trauma surgeon’s nightmare, suggested investigators here.

Dabigatran (Pradaxa) is a direct thrombin inhibitor approved in the United States for the reduction of risk from stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Unlike Coumadin/warfarin, dabigatran’s effects are not reversible.

Neil Osterweil/IMNG Medical Media

Pharmacists at the Scripps Mercy Hospital in San Diego evaluated prescribing patterns for dabigatran among patients in their hospital and found that 13% received it for off-label indications, a practice that has the potential for patient harm, they said at the annual meeting of the Society of Critical Care Medicine.

Of 38 patients prescribed dabigatran during their hospital stay, 33 received it for the Food and Drug Administration–approved indication but 5 (13%) received it for other, unspecified indications, reported Dr. Trevor Perry and Dr. Harminder Sikand, both clinical pharmacists at Scripps. "Prescribing was equally divided between house staff, hospitalists, and cardiologists," researchers reported (Crit. Care Med. 2012 [doi:10.1097/01.ccm.0000424500.73199.04]).

The incidence of gastrointestinal bleeding with the drug in their study was 10.5%, higher than the 6.1% rate for any gastrointestinal bleeding stated in the package insert, Dr. Perry said in an interview.

In addition, pharmacists needed to correct the dabigatran dose in 24% of patients, and dabigatran had noticeable effects on clotting parameters, with 74% of patients having an activated partial thromboplastin time (aPTT) above the upper limit of normal, and 64% of patients having an international normalized ratio (INR) above the upper limit.

This finding suggests that in these patients, the clotting assays "may be useful to determine medication adherence but not to determine the level of anticoagulation," the authors wrote in a poster presentation.

"Clinicians need to be aware of the appropriate indication for use and renal dosing of dabigatran to prevent patient harm, as only 87% of patients were prescribed dabigatran for the FDA-labeled indication," they noted.

Major heparin boost needed

In a separate study, Dr. Thomas Edrich from the department of anesthesiology, perioperative and pain medicine at Brigham & Women’s Hospital in Boston and his colleagues found that for patients scheduled for catheter-based atrial ablation procedures, those who were on dabigatran required an approximately 50% greater dose of heparin to achieve full anticoagulation for the procedure than did patients on warfarin (Crit. Care Med. 2012 [doi:10.1097/01.ccm.0000425177.10736.a4]).

Patients who had been on warfarin until 12 hours before the procedure required about 3,000-4,000 IU of heparin/hr to achieve an activated clotting time of 350 seconds, compared with about 6,500-9,000 IU/hr in patients on dabigatran, Dr. Edrich said. They studied retrospective data for 36 patients on dabigatran, 100 patients on warfarin (53 with an INR above 2.0), and 29 patients on no anticoagulation.

"The interesting finding here is that if you’ve been on dabigatran, you’re going to need twice as much heparin," he said in a poster discussion session.

Patients like it, surgeons don’t

Although patients like the convenience of oral dosing without the need for regular INR monitoring with the new anticoagulants, often they are not told that convenience may come at a very high price if there is no effective therapy to reverse the anticoagulation effect, commented Dr. Christine Toevs, a critical care surgeon at the West Penn Allegheny Health System in Pittsburgh.

"The problem is that patients aren\'t informed enough to make that choice. They understand that they’re not getting their labs drawn once a week or twice a week, and they understand that’s not a cost that they are paying. But if they fall and they have a head injury, that is a life lost, and we cannot stop it," she said during a debate on the costs of new medications.

Dr. Perry’s and Dr. Edrich’s studies were internally funded; they reported having no financial disclosures. Dr. Toevs reported having no financial disclosures.