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

Abstract

Introduction: Among 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 Analysis: The 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 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 ClinicalTrials.gov registration (NCT05239195) on February 14, 2022, prior to the enrollment of the first patient.

Competing Interest Statement

Matthew W. Semler was supported by the National Heart Lung and Blood Institute (K23HL143053). Jonathan D. Casey was supported by the National Heart Lung and Blood Institute (K23HL153584-01). John P. Gaillard received support from the CHEST Foundation for instruction and travel. Todd W. Rice was supported in part by the National Institutes of Health and received consulting payments from Cumberland Pharmaceuticals, Inc. and Cytovale, Inc., and served on a data safety and monitoring board for Sanofi, Inc. All other authors have no competing interests.

Clinical Trial

NCT05239195

Funding Statement

This study was funded in part by the Department of Defense, Defense Health Agency, J9 Office, RESTORAL program. Data collection utilized the Research Electronic Data Capture (REDCap) tool developed and maintained with Vanderbilt Institute for Clinical and Translational Research grant support (UL1 TR000445 from NCATS/NIH). The funding institutions had no role in (1) conception, design, or conduct of the study, (2) collection, management, analysis, interpretation, or presentation of the data, or (3) preparation, review, or approval of the manuscript. The views expressed are those of the authors and do not reflect the official views or policy of the Department of Defense or its components.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The institutional review board of Vanderbilt University Medical Center gave ethical approval for this work

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

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I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.

Yes

Data Availability

All data that will be produced in the present study are available upon reasonable request to the authors

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