BOugie or stylet in patients UnderGoing Intubation Emergently (BOUGIE): protocol and statistical analysis plan for a randomised clinical trial

Brian Driver; Matthew W Semler; Wesley H Self; Adit A Ginde; Sheetal Gandotra; Stacy A Trent; Lane M Smith; John P Gaillard; David B Page; Micah R Whitson; Derek J Vonderhaar; A M Joffe; Jason R West; Christopher Hughes; Janna S Landsperger; Michelle P Howell; Derek W Russell; Swati Gulati; Itay Bentov; Steven Mitchell; Andrew Latimer; Kevin Doerschug; Vikas Koppurapu; Kevin W Gibbs; Li Wang; Christopher John Lindsell; David Janz; Todd W Rice; Matthew E Prekker; Jonathan D Casey; BOUGIE Investigators

doi:10.1136/bmjopen-2020-047790

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BOugie or stylet in patients UnderGoing Intubation Emergently (BOUGIE): protocol and statistical analysis plan for a randomised clinical trial

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BOugie or stylet in patients UnderGoing Intubation Emergently (BOUGIE): protocol and statistical analysis plan for a randomised clinical trial

Brian Driver, Matthew W Semler, Wesley H Self, Adit A Ginde, Sheetal Gandotra, Stacy A Trent, Lane M Smith, John P Gaillard, David B Page, Micah R Whitson, …

BMJ open, Vol.11(5), pp.e047790-e047790

05/25/2021

DOI: 10.1136/bmjopen-2020-047790

PMCID: PMC8154972

PMID: 34035106

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Abstract

IntroductionIntubation-related complications are less frequent when intubation is successful on the first attempt. The rate of first attempt success in the emergency department (ED) and intensive care unit (ICU) is typically less than 90%. The bougie, a semirigid introducer that can be placed into the trachea to facilitate a Seldinger-like technique of tracheal intubation and is typically reserved for difficult or failed intubations, might improve first attempt success. Evidence supporting its use, however, is from a single academic ED with frequent bougie use. Validation of these findings is needed before widespread implementation.Methods and analysisThe BOugie or stylet in patients Undergoing Intubation Emergently trial is a prospective, multicentre, non-blinded randomised trial being conducted in six EDs and six ICUs in the USA. The trial plans to enrol 1106 critically ill adults undergoing orotracheal intubation. Eligible patients are randomised 1:1 for the use of a bougie or use of an endotracheal tube with stylet for the first intubation attempt. The primary outcome is successful intubation on the first attempt. The secondary outcome is severe hypoxaemia, defined as an oxygen saturation less than 80% between induction until 2 min after completion of intubation. Enrolment began on 29 April 2019 and is expected to be completed in 2021.Ethics and disseminationThe trial protocol was approved with waiver of informed consent by the Central Institutional Review Board at Vanderbilt University Medical Center or the local institutional review board at an enrolling site. The results will be submitted for publication in a peer-reviewed journal and presented at scientific conferences.Trial registration numberClinicalTrials.gov Registry (NCT03928925).

Details

Title: Subtitle: BOugie or stylet in patients UnderGoing Intubation Emergently (BOUGIE): protocol and statistical analysis plan for a randomised clinical trial
Creators: Brian Driver - Hennepin County Medical Center
Matthew W Semler - Vanderbilt University
Wesley H Self - Vanderbilt University Medical Center
Adit A Ginde - University of Colorado Denver
Sheetal Gandotra - Pulmonary and Allergy Associates
Stacy A Trent - Denver Health Medical Center
Lane M Smith - Atrium Health Wake Forest Baptist
John P Gaillard - Atrium Health Wake Forest Baptist
David B Page - University of Alabama at Birmingham
Micah R Whitson - University of Alabama at Birmingham
Derek J Vonderhaar - Ochsner Health System
A M Joffe - University of Washington
Jason R West - Lincoln Medical Center
Christopher Hughes - Vanderbilt University Medical Center
Janna S Landsperger - Vanderbilt University
Michelle P Howell - University of Colorado Denver
Derek W Russell - Pulmonary and Allergy Associates
Swati Gulati - Pulmonary and Allergy Associates
Itay Bentov - University of Washington
Steven Mitchell - University of Washington
Andrew Latimer - University of Washington
Kevin Doerschug - University of Iowa
Vikas Koppurapu - University of Iowa Hospitals and Clinics
Kevin W Gibbs - Wake Forest University
Li Wang - Vanderbilt University Medical Center
Christopher John Lindsell - Vanderbilt University Medical Center
David Janz - University of New Orleans
Todd W Rice - Vanderbilt University
Matthew E Prekker - Hennepin County Medical Center
Jonathan D Casey - Vanderbilt University
BOUGIE Investigators
Resource Type: Journal article
Publication Details: BMJ open, Vol.11(5), pp.e047790-e047790
DOI: 10.1136/bmjopen-2020-047790
PMID: 34035106
PMCID: PMC8154972
NLM abbreviation: BMJ Open
ISSN: 2044-6055
eISSN: 2044-6055
Grant note: DOI: 10.13039/100000050, name: National Heart, Lung, and Blood Institute, award: K12HL133117, K23HL143053, K23HL153584; name: University of Alabama at Birmingham Walter Frommeyer Jr Fellowship, award: VISN 7 Research Development Award; DOI: 10.13039/100000002, name: National Institutes of Health, award: UL1 TR000445
Language: English
Date published: 05/25/2021
Academic Unit: Pulmonary, Critical Care, and Occupational Medicine; Internal Medicine
Record Identifier: 9984359573302771

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