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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, A M; 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.
  • Driver B; Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, Minnesota, USA briandriver@gmail.com.
  • Semler MW; Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.
  • Self WH; Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
  • Ginde AA; Department of Emergency Medicine, University of Colorado Denver School of Medicine, Aurora, Colorado, USA.
  • Gandotra S; Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, The University of Alabama at Birmingham, Birmingham, Alabama, USA.
  • Trent SA; Pulmonary Section, Birmingham Veteran's Affairs Medical Center, Birmingham, Alabama, USA.
  • Smith LM; Department of Emergency Medicine, University of Colorado Denver School of Medicine, Aurora, Colorado, USA.
  • Gaillard JP; Department of Emergency Medicine, Denver Health Medical Center, Denver, Colorado, USA.
  • Page DB; Department of Emergency Medicine, Wake Forest Baptist Medical Center, Winston-Salem, North Carolina, USA.
  • Whitson MR; Department of Emergency Medicine, Wake Forest Baptist Medical Center, Winston-Salem, North Carolina, USA.
  • Vonderhaar DJ; Department of Emergency Medicine, The University of Alabama at Birmingham, Birmingham, Alabama, USA.
  • Joffe AM; Department of Medicine, Division of Pulmonary, Allergy & Critical Care Medicine, The University of Alabama at Birmingham, Birmingham, Alabama, USA.
  • West JR; Department of Emergency Medicine, The University of Alabama at Birmingham, Birmingham, Alabama, USA.
  • Hughes C; Department of Medicine, Division of Pulmonary, Allergy & Critical Care Medicine, The University of Alabama at Birmingham, Birmingham, Alabama, USA.
  • Landsperger JS; Department of Pulmonary/Critical Care Medicine, Ochsner Health System, New Orleans, Louisiana, USA.
  • Howell MP; Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, Washington, USA.
  • Russell DW; Department of Emergency Medicine, Lincoln Medical Center, Bronx, New York, USA.
  • Gulati S; Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
  • Bentov I; Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.
  • Mitchell S; Department of Emergency Medicine, University of Colorado Denver School of Medicine, Aurora, Colorado, USA.
  • Latimer A; Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, The University of Alabama at Birmingham, Birmingham, Alabama, USA.
  • Doerschug K; Pulmonary Section, Birmingham Veteran's Affairs Medical Center, Birmingham, Alabama, USA.
  • Koppurapu V; Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, The University of Alabama at Birmingham, Birmingham, Alabama, USA.
  • Gibbs KW; Pulmonary Section, Birmingham Veteran's Affairs Medical Center, Birmingham, Alabama, USA.
  • Wang L; Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, Washington, USA.
  • Lindsell CJ; Department of Emergency Medicine, University of Washington, Seattle, Washington, USA.
  • Janz D; Department of Emergency Medicine, University of Washington, Seattle, Washington, USA.
  • Rice TW; Department of Internal Medicine, University of Iowa Hospitals and Clinics Pathology, Iowa City, Iowa, USA.
  • Prekker ME; Department of Internal Medicine, University of Iowa Hospitals and Clinics Pathology, Iowa City, Iowa, USA.
  • Casey JD; Department of Medicine, Section of Pulmonary, Critical Care, Allergy and Immunologic Disease, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.
BMJ Open ; 11(5): e047790, 2021 05 25.
Article in English | MEDLINE | ID: covidwho-1376497
ABSTRACT

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 11 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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Full text: Available Collection: International databases Database: MEDLINE Main subject: Critical Illness / Intubation, Intratracheal Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Adult / Humans Language: English Journal: BMJ Open Year: 2021 Document Type: Article Affiliation country: Bmjopen-2020-047790

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Critical Illness / Intubation, Intratracheal Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Adult / Humans Language: English Journal: BMJ Open Year: 2021 Document Type: Article Affiliation country: Bmjopen-2020-047790