Speakers

Matthew Prekker, MD, MPH
Associate Professor of Emergency Medicine and Pulmonary and Critical Care Medicine
Hennepin County Medical Center
University of Minnesota Medical School

Jonathan Casey, MD, MSc
Assistant Professor of Pulmonary and Critical Care
Vanderbilt University Medical Center
Director, Coordinating Center, Pragmatic Critical Care Research Group

Slides

Keywords

Critical Care Medicine, Pragmatic Trial, DEVICE, Laryngoscope

Key Points

• Emergency tracheal intubation is a common and high-risk procedure. When the procedure is performed in the Operating Room complications are rare (2%); when performed in the Emergency Department and ICU complications are more common (40%). Failure to intubate on the first attempt occurs in 20-30% of tracheal intubations in the ED or ICU, and it is associated with life-threatening complications.

• Two devices are commonly used to perform tracheal intubation, direct laryngoscope and video laryngoscope. A direct laryngoscope is used for approximately 80% of ED and ICU intubations worldwide, and current guidelines state that use of either a direct or video laryngoscope is acceptable.

• The DEVICE trial hypothesized that the use of a video laryngoscope will increase the incidence of successful intubation on the first attempt. DEVICE, part of the Pragmatic Critical Care Research Group, was a multicenter, parallel-group, unblinded pragmatic, randomized trial compared the use of a video laryngoscope with the use of a direct laryngoscope for tracheal intubation of critically ill adults at 17 EDs and ICUs across U.S. The trial operated under an IRB waiver of informed consent with a patient information sheet.

• Patients were randomized 1:1 in blocks of variable size, stratified by trial site with allocation concealed until randomization using opaque envelopes containing trial group assignment. For patients assigned to the video arm, clinicians used a video laryngoscope on the first attempt and used the screen to view the cords. For the direct arm, operators used direct laryngoscope on first attempt and could not have a camera or screen.

• The primary outcome was successful intubation on the first attempt. The secondary outcomes were severe complications between induction and 2 minutes after intubation, such as severe hypoxemia, severe hypotension, new or increased vasopressor administration, cardiac arrest, or death.

• After enrolling patients for 8 months, the data safety board recommended trial enrollment stop because the prespecified stopping criteria for efficacy had been met.

• Nearly 2,000 patients were assessed for eligibility and 1,417 patients were enrolled. Successful intubation on the first attempt occurred in 85.1% for the video laryngoscope group and 70.8% in the direct laryngoscope group. There was an observed halving of failure with video laryngoscope use compared to direct laryngoscope use.

 

Learn more

Read more in the New England Journal of Medicine.

Discussion Themes

-Why did the RSI trial follow a different path – not a waiver of consent? There was not an opportunity for informed consent in DEVICE trial, when there was not a minute to spare for a procedure that takes 2 minutes to complete. For the RSI trial the FDA regulations had not been updated yet. We discussed doing RSI under waiver, we asked FDA a question and FDA said it could only be conducted under EFIC.

-If most intubations in the U.S. are done by direct laryngoscope (DL), what would the difference be since most of trainees are facile with video and many other clinicians are more comfortable with DL. Could the difference be the comfort of the operator? Our trial results don’t apply to operators who intubate thousands of times. The operators had less than 250 intubations. For the novice operator, VL cut rate of failure on the first attempt from 50% to 20% (3 to 4 patients). For moderately experienced operators, VL increased by 6%. For late career expert operators results of our trail may not apply.

Tags

#pctGR, @Collaboratory1