| Title: |
DirEct versus VIdeo LaryngosCopE (DEVICE): protocol and statistical analysis plan for a randomised clinical trial in critically ill adults undergoing emergency tracheal intubation |
| Authors: |
Prekker, Matthew E; Driver, Brian E; Trent, Stacy A; Resnick-Ault, Daniel; Seitz, Kevin; Russell, Derek W; Gandotra, Sheetal; Gaillard, John P; Gibbs, Kevin W; Latimer, Andrew; Whitson, Micah R; Ghamande, Shekhar; Vonderhaar, Derek J; Walco, Jeremy P; Hansen, Sydney J; Douglas, Ivor S; Barnes, Christopher R; Krishnamoorthy, Vijay; Bastman, Jill J; Lloyd, Bradley Daniel; Robison, Sarah W; Palakshappa, Jessica A; Mitchell, Steven; Page, David B; White, Heath D; Espinera, Alyssa; Hughes, Christopher; Joffe, Aaron M; Herbert, J Taylor; Schauer, Steven G; Long, Brit J; Imhoff, Brant; Wang, Li; Rhoads, Jillian P; Womack, Kelsey N; Janz, David; Self, Wesley H; Rice, Todd W; Ginde, Adit A; Casey, Jonathan D; Semler, Matthew W |
| Contributors: |
Vanderbilt Institute for Clinical and Translational Research; NHLBI; the Department of Defense, Defense Health Agency, J9 Office; NCATS/NIH |
| Source: |
BMJ Open ; volume 13, issue 1, page e068978 ; ISSN 2044-6055 2044-6055 |
| Publisher Information: |
BMJ |
| Publication Year: |
2023 |
| Description: |
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 |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| DOI: |
10.1136/bmjopen-2022-068978 |
| Availability: |
https://doi.org/10.1136/bmjopen-2022-068978; https://syndication.highwire.org/content/doi/10.1136/bmjopen-2022-068978 |
| Rights: |
http://creativecommons.org/licenses/by-nc/4.0/ |
| Accession Number: |
edsbas.AB20D586 |
| Database: |
BASE |