Effect of Noninvasive Ventilation Delivered by Helmet vs Face Mask on the Rate of Endotracheal Intubation in Patients With Acute Respiratory Distress Syndrome

Bhakti K. Patel, MD1; Krysta S. Wolfe, MD1; Anne S. Pohlman, MSN1; Jesse B. Hall, MD1; John P. Kress, MD1

[+] Author Affiliations,   JAMA. Published online May 15, 2016. doi:10.1001/jama.2016.6338

Non-­invasive pulmonary ventilation has relied on face masks since anyone can remember. But there is another option to help critically ill patients breathe easier and in greater comfort, and that is helmet-­based, or hood-­based, ventilation. The patient doesn’t have anything touching the face and can see out through the transparent helmet. An inflatable cuff wraps around the neck to create a seal that is sufficiently tight but that doesn’t hurt the patient.

Clinical researchers at the University of Chicago have been studying hoods made by Sea-Long Medical Systems out of Louisville, Kentucky compared to traditional face masks when ventilating patients who needed at least eight hours of pulmonary assistance. In the trial on 83 patients, half of whom received masks and the other helmets, the performance of helmet ventilation was so impressive compared to traditional face masks that the oversight board decided to stop the trial so all patients can benefit from the helmet-­based ventilation. The study appears in the Journal of the American Medical Association.

“In this group of critically ill patients, the helmet made a substantial difference,” said pulmonologist John P. Kress, MD, professor of medicine at the University of Chicago and senior author of the study, in a statement. “The University’s data and safety monitoring board recommended that we stop the trial early because the helmet consistently demonstrated multiple advantages, particularly the reduced need to intubate patients and longer-term reduction in mortality.”

“After reviewing our data,” he added, “the board felt that it would be difficult to justify enrolling more patients in the face­mask arm of the trial, which exposed them to greater risks.”

From the abstract in JAMA:

83 patients (45% women; median age, 59 years; median Acute Physiology and Chronic Health Evaluation [APACHE] II score, 26) were included in the analysis after the trial was stopped early based on predefined criteria for efficacy. The intubation rate was 61.5% (n=24) for the face mask group and 18.2% (n=8) for the helmet group (absolute difference, −43.3%; 95% CI, −62.4% to −24.3%; P<.001). The number of entilator-free days was significantly higher in the helmet group (28 vs 12.5, P<.001). At 90 days, 15 patients (34.1%) in the helmet group died compared with 22 patients (56.4%) in the face mask group (absolute difference, −22.3%; 95% CI, −43.3 to −1.4; P=.02). Adverse events included 3 interface-­related skin ulcers for each group (ie, 7.6% in the face mask group had nose ulcers and 6.8% in the helmet group had neck ulcers).

Personal comments: It sounds like this should become standard across Israel ASAP. A trial could be done in Israel to see if the numbers match this previous study. But not to be intubated would be a huge positive improvement in quality of care.

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