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


Journal

BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874

Informations de publication

Date de publication:
13 01 2023
Historique:
entrez: 13 1 2023
pubmed: 14 1 2023
medline: 18 1 2023
Statut: epublish

Résumé

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. The 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. ClinicalTrials.gov Registry (NCT05239195).

Identifiants

pubmed: 36639210
pii: bmjopen-2022-068978
doi: 10.1136/bmjopen-2022-068978
pmc: PMC9843219
doi:

Banques de données

ClinicalTrials.gov
['NCT05239195']

Types de publication

Clinical Trial Protocol Journal Article Research Support, N.I.H., Extramural Research Support, U.S. Gov't, Non-P.H.S.

Langues

eng

Sous-ensembles de citation

IM

Pagination

e068978

Subventions

Organisme : NHLBI NIH HHS
ID : K08 HL148514
Pays : United States
Organisme : NHLBI NIH HHS
ID : K23 HL153584
Pays : United States
Organisme : NHLBI NIH HHS
ID : K23 HL143053
Pays : United States

Informations de copyright

© 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.

Déclaration de conflit d'intérêts

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.

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Auteurs

Matthew E Prekker (ME)

Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, Minnesota, USA Matthew.Prekker@hcmed.org.
Department of Medicine, Division of Pulmonary, Allergy, and Critical Care Medicine, Hennepin County Medical Center, Minneapolis, Minnesota, USA.

Brian E Driver (BE)

Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, Minnesota, USA.

Stacy A Trent (SA)

Department of Emergency Medicine, Denver Health Medical Center, Denver, Colorado, USA.
Department of Emergency Medicine, University of Colorado Denver School of Medicine, Aurora, Colorado, USA.

Daniel Resnick-Ault (D)

Department of Emergency Medicine, University of Colorado Denver School of Medicine, Aurora, Colorado, USA.

Kevin Seitz (K)

Division of Pulmonary, Allergy, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.

Derek W Russell (DW)

Pulmonary Section, Birmingham Veterans Affairs Medical Center, Birmingham, Alabama, USA.
Department of Medicine, Division of Pulmonary, Allergy, and Critical Care Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA.

Sheetal Gandotra (S)

Department of Medicine, Division of Pulmonary, Allergy, and Critical Care Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA.

John P Gaillard (JP)

Department of Emergency Medicine, Atrium Health Wake Forest Baptist, Winston-Salem, North Carolina, USA.
Department of Anesthesiology, Section on Critical Care, Atrium Health Wake Forest Baptist, Winston-Salem, North Carolina, USA.

Kevin W Gibbs (KW)

Department of Medicine, Section of Pulmonary, Critical Care, Allergy and Immunology, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.

Andrew Latimer (A)

Department of Emergency Medicine, University of Washington Harborview Medical Center, Seattle, Washington, USA.

Micah R Whitson (MR)

Department of Medicine, Division of Pulmonary, Allergy, and Critical Care Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA.
Department of Emergency Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA.

Shekhar Ghamande (S)

Department of Medicine, Division of Pulmonary Disease and Critical Care Medicine, Baylor Scott & White Medical Center, Temple, Texas, USA.

Derek J Vonderhaar (DJ)

Department of Pulmonary and Critical Care Medicine, Ochsner Health, New Orleans, Louisiana, USA.

Jeremy P Walco (JP)

Department of Anesthesiology, Division of Anesthesia Critical Care Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.

Sydney J Hansen (SJ)

Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, Minnesota, USA.
Department of Medicine, Division of Pulmonary, Allergy, and Critical Care Medicine, Hennepin County Medical Center, Minneapolis, Minnesota, USA.

Ivor S Douglas (IS)

Division of Pulmonary and Critical Care Medicine, Denver Health Medical Center, Denver, Colorado, USA.
Department of Medicine, Division of Pulmonary and Critical Care Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA.

Christopher R Barnes (CR)

Department of Anesthesiology and Critical Care Medicine, University of Washington Harborview Medical Center, Seattle, Washington, USA.

Vijay Krishnamoorthy (V)

Department of Anesthesiology, Duke University School of Medicine, Durham, North Carolina, USA.

Jill J Bastman (JJ)

Department of Emergency Medicine, University of Colorado Denver School of Medicine, Aurora, Colorado, USA.

Bradley Daniel Lloyd (BD)

Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.

Sarah W Robison (SW)

Pulmonary Section, Birmingham Veterans Affairs Medical Center, Birmingham, Alabama, USA.
Department of Medicine, Division of Pulmonary, Allergy, and Critical Care Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA.

Jessica A Palakshappa (JA)

Department of Medicine, Section of Pulmonary, Critical Care, Allergy and Immunology, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.

Steven Mitchell (S)

Department of Emergency Medicine, University of Washington Harborview Medical Center, Seattle, Washington, USA.

David B Page (DB)

Department of Medicine, Division of Pulmonary, Allergy, and Critical Care Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA.

Heath D White (HD)

Department of Medicine, Division of Pulmonary Disease and Critical Care Medicine, Baylor Scott & White Medical Center, Temple, Texas, USA.

Alyssa Espinera (A)

Department of Pulmonary and Critical Care Medicine, Ochsner Health, New Orleans, Louisiana, USA.

Christopher Hughes (C)

Department of Anesthesiology, Division of Anesthesia Critical Care Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.

Aaron M Joffe (AM)

Department of Anesthesiology and Critical Care Medicine, University of Washington Harborview Medical Center, Seattle, Washington, USA.

J Taylor Herbert (JT)

Department of Anesthesiology, Duke University School of Medicine, Durham, North Carolina, USA.

Steven G Schauer (SG)

US Army Institute of Surgical Research, Fort Sam Houston, Texas, USA.

Brit J Long (BJ)

59th Medical Wing, Joint Base San Antonio-Lackland, Texas, USA.

Brant Imhoff (B)

Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.

Li Wang (L)

Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.

Jillian P Rhoads (JP)

Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, Nashville, Tennessee, USA.

Kelsey N Womack (KN)

Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, Nashville, Tennessee, USA.

David Janz (D)

Department of Medicine, Section of Pulmonary/Critical Care Medicine and Allergy/Immunology, University Medical Center New Orleans, New Orleans, Louisiana, USA.

Wesley H Self (WH)

Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, Nashville, Tennessee, USA.

Todd W Rice (TW)

Division of Pulmonary, Allergy, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.

Adit A Ginde (AA)

Department of Emergency Medicine, University of Colorado Denver School of Medicine, Aurora, Colorado, USA.

Jonathan D Casey (JD)

Division of Pulmonary, Allergy, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.

Matthew W Semler (MW)

Division of Pulmonary, Allergy, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.

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Classifications MeSH