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

INTRODUCTION: Intubation-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...

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Autores principales: Driver, Brian, Semler, Matthew W, Self, Wesley H, Ginde, Adit A, Gandotra, Sheetal, Trent, Stacy A, Smith, Lane M, Gaillard, John P, Page, David B, Whitson, Micah R, Vonderhaar, Derek J, Joffe, AM, West, Jason R, Hughes, Christopher, Landsperger, Janna S, Howell, Michelle P, Russell, Derek W, Gulati, Swati, Bentov, Itay, Mitchell, Steven, Latimer, Andrew, Doerschug, Kevin, Koppurapu, Vikas, Gibbs, Kevin W, Wang, Li, Lindsell, Christopher John, Janz, David, Rice, Todd W, Prekker, Matthew E, Casey, Jonathan D
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8154972/
https://www.ncbi.nlm.nih.gov/pubmed/34035106
http://dx.doi.org/10.1136/bmjopen-2020-047790
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author Driver, Brian
Semler, Matthew W
Self, Wesley H
Ginde, Adit A
Gandotra, Sheetal
Trent, Stacy A
Smith, Lane M
Gaillard, John P
Page, David B
Whitson, Micah R
Vonderhaar, Derek J
Joffe, AM
West, Jason R
Hughes, Christopher
Landsperger, Janna S
Howell, Michelle P
Russell, Derek W
Gulati, Swati
Bentov, Itay
Mitchell, Steven
Latimer, Andrew
Doerschug, Kevin
Koppurapu, Vikas
Gibbs, Kevin W
Wang, Li
Lindsell, Christopher John
Janz, David
Rice, Todd W
Prekker, Matthew E
Casey, Jonathan D
author_facet Driver, Brian
Semler, Matthew W
Self, Wesley H
Ginde, Adit A
Gandotra, Sheetal
Trent, Stacy A
Smith, Lane M
Gaillard, John P
Page, David B
Whitson, Micah R
Vonderhaar, Derek J
Joffe, AM
West, Jason R
Hughes, Christopher
Landsperger, Janna S
Howell, Michelle P
Russell, Derek W
Gulati, Swati
Bentov, Itay
Mitchell, Steven
Latimer, Andrew
Doerschug, Kevin
Koppurapu, Vikas
Gibbs, Kevin W
Wang, Li
Lindsell, Christopher John
Janz, David
Rice, Todd W
Prekker, Matthew E
Casey, Jonathan D
author_sort Driver, Brian
collection PubMed
description INTRODUCTION: Intubation-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 ANALYSIS: The 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 DISSEMINATION: The 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 NUMBER: ClinicalTrials.gov Registry (NCT03928925).
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spelling pubmed-81549722021-06-10 BOugie or stylet in patients UnderGoing Intubation Emergently (BOUGIE): protocol and statistical analysis plan for a randomised clinical trial Driver, Brian Semler, Matthew W Self, Wesley H Ginde, Adit A Gandotra, Sheetal Trent, Stacy A Smith, Lane M Gaillard, John P Page, David B Whitson, Micah R Vonderhaar, Derek J Joffe, AM West, Jason R Hughes, Christopher Landsperger, Janna S Howell, Michelle P Russell, Derek W Gulati, Swati Bentov, Itay Mitchell, Steven Latimer, Andrew Doerschug, Kevin Koppurapu, Vikas Gibbs, Kevin W Wang, Li Lindsell, Christopher John Janz, David Rice, Todd W Prekker, Matthew E Casey, Jonathan D BMJ Open Emergency Medicine INTRODUCTION: Intubation-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 ANALYSIS: The 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 DISSEMINATION: The 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 NUMBER: ClinicalTrials.gov Registry (NCT03928925). BMJ Publishing Group 2021-05-25 /pmc/articles/PMC8154972/ /pubmed/34035106 http://dx.doi.org/10.1136/bmjopen-2020-047790 Text en © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Emergency Medicine
Driver, Brian
Semler, Matthew W
Self, Wesley H
Ginde, Adit A
Gandotra, Sheetal
Trent, Stacy A
Smith, Lane M
Gaillard, John P
Page, David B
Whitson, Micah R
Vonderhaar, Derek J
Joffe, AM
West, Jason R
Hughes, Christopher
Landsperger, Janna S
Howell, Michelle P
Russell, Derek W
Gulati, Swati
Bentov, Itay
Mitchell, Steven
Latimer, Andrew
Doerschug, Kevin
Koppurapu, Vikas
Gibbs, Kevin W
Wang, Li
Lindsell, Christopher John
Janz, David
Rice, Todd W
Prekker, Matthew E
Casey, Jonathan D
BOugie or stylet in patients UnderGoing Intubation Emergently (BOUGIE): protocol and statistical analysis plan for a randomised clinical trial
title BOugie or stylet in patients UnderGoing Intubation Emergently (BOUGIE): protocol and statistical analysis plan for a randomised clinical trial
title_full BOugie or stylet in patients UnderGoing Intubation Emergently (BOUGIE): protocol and statistical analysis plan for a randomised clinical trial
title_fullStr BOugie or stylet in patients UnderGoing Intubation Emergently (BOUGIE): protocol and statistical analysis plan for a randomised clinical trial
title_full_unstemmed BOugie or stylet in patients UnderGoing Intubation Emergently (BOUGIE): protocol and statistical analysis plan for a randomised clinical trial
title_short BOugie or stylet in patients UnderGoing Intubation Emergently (BOUGIE): protocol and statistical analysis plan for a randomised clinical trial
title_sort bougie or stylet in patients undergoing intubation emergently (bougie): protocol and statistical analysis plan for a randomised clinical trial
topic Emergency Medicine
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8154972/
https://www.ncbi.nlm.nih.gov/pubmed/34035106
http://dx.doi.org/10.1136/bmjopen-2020-047790
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