1. DirEct versus VIdeo LaryngosCopE (DEVICE): protocol and statistical analysis plan for a randomised clinical trial in critically ill adults undergoing emergency tracheal intubation.
- Author
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Prekker ME, Driver BE, Trent SA, Resnick-Ault D, Seitz K, Russell DW, Gandotra S, Gaillard JP, Gibbs KW, Latimer A, Whitson MR, Ghamande S, Vonderhaar DJ, Walco JP, Hansen SJ, Douglas IS, Barnes CR, Krishnamoorthy V, Bastman JJ, Lloyd BD, Robison SW, Palakshappa JA, Mitchell S, Page DB, White HD, Espinera A, Hughes C, Joffe AM, Herbert JT, Schauer SG, Long BJ, Imhoff B, Wang L, Rhoads JP, Womack KN, Janz D, Self WH, Rice TW, Ginde AA, Casey JD, and Semler MW
- Subjects
- Humans, Adult, Critical Illness therapy, Prospective Studies, Laryngoscopy methods, Intubation, Intratracheal methods, Randomized Controlled Trials as Topic, Multicenter Studies as Topic, Laryngoscopes
- Abstract
Introduction: Among critically ill patients undergoing orotracheal intubation in the emergency department (ED) or intensive care unit (ICU), failure to visualise 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 the use of a video laryngoscope increases the incidence of successful intubation on the first attempt compared with the use of a direct laryngoscope., Methods and Analysis: The D ir E ct versus VI deo Laryngos C op E (DEVICE) trial is a prospective, multicentre, non-blinded, randomised trial being conducted in 7 EDs and 10 ICUs in the USA. The trial plans to enrol up to 2000 critically ill adults undergoing orotracheal intubation with a laryngoscope. Eligible patients are randomised 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 min after intubation, defined as the occurrence of one or more of the following: severe hypoxaemia (lowest oxygen saturation <80%); severe hypotension (systolic blood pressure <65 mm Hg or new or increased vasopressor administration); cardiac arrest or death. Enrolment began on 19 March 2022 and is expected to be completed in 2023., Ethics and Dissemination: The 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 Registration Number: ClinicalTrials.gov Registry (NCT05239195)., Competing Interests: Competing interests: MWS was supported by the National Heart, Lung and Blood Institute (K23HL143053). JDC was supported by the National Heart, Lung and Blood Institute (K23HL153584-01). JPG received support from the CHEST Foundation for instruction and travel. TWR was supported in part by the National Institutes of Health and received consulting payments from Cumberland Pharmaceuticals and Cytovale, and served on a data safety and monitoring board for Sanofi., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
- Published
- 2023
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