DirEct versus VIdeo LaryngosCopE (DEVICE): Protocol and statistical analysis plan for a randomized clinical trial in critically ill adults undergoing emergency tracheal intubation

IntroductionAmong critically ill patients undergoing orotracheal intubation in the emergency department (ED) or intensive care unit (ICU), failure to visualize the vocal cords and intubate the trachea on the first attempt is associated with an increased risk of complications. Two types of laryngoscopes are commonly available: direct laryngoscopes and video laryngoscopes. For critically ill adults undergoing emergency tracheal intubation, it remains uncertain whether use of a video laryngoscope increases the incidence of successful intubation on the first attempt compared with use of a direct laryngoscope. Methods and AnalysisThe DirEct Versus VIdeo LaryngosCopE (DEVICE) trial is a prospective, multi-center, non-blinded, randomized trial being conducted in 6 EDs and 10 ICUs in the United States. The trial plans to enroll up to 2,000 critically ill adults undergoing orotracheal intubation with a laryngoscope. Eligible patients are randomized 1:1 to the use of a video laryngoscope or a direct laryngoscope for the first intubation attempt. The primary outcome is successful intubation on the first attempt. The secondary outcome is the incidence of severe complications between induction and 2 minutes after intubation, defined as the occurrence of one or more of the following: severe hypoxemia (lowest oxygen saturation < 80%); severe hypotension (systolic blood pressure < 65 mm Hg or new or increased vasopressor administration); cardiac arrest; or death. Enrollment began on March 16, 2022 and is expected to be completed in 2023. Ethics and DisseminationThe trial protocol was approved with waiver of informed consent by the single institutional review board at Vanderbilt University Medical Center and the Human Research Protection Office of the Department of Defense. The results will be presented at scientific conferences and submitted for publication in a peer-reviewed journal. Trial RegistrationClinicalTrials.gov registration (NCT05239195) on February 14, 2022, prior to the enrollment of the first patient. Strengths and Limitations of this StudyO_LIThis protocol describes in detail the design and methods for a large, pragmatic trial of laryngoscope type for the emergency tracheal intubation of critically ill adults. C_LIO_LIConduct in the emergency departments and intensive care units of multiple centers among operators with diverse prior experience with tracheal intubation, as well as broad patient eligibility criteria, will increase the external validity of trial results. C_LIO_LIPatients, clinicians, and investigators are not blinded to the study group assignment after randomization. C_LI