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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...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2021
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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). |
format | Online Article Text |
id | pubmed-8154972 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
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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