BOugie or stylet in patients UnderGoing Intubation Emergently (BOUGIE): protocol and statistical analysis plan for a randomised clinical trial. Issue 5 (25th May 2021)

• Record Type: Journal Article
• Authors: 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
• Other Names: author non-byline.; Barnes Christopher author non-byline.; Cupelo Alicia K author non-byline.; DeVries Paige author non-byline.; Dye Sally author non-byline.; Fletcher Andrea author non-byline.; Gray Christopher S author non-byline.; High Kevin author non-byline.; Kurz Michael C author non-byline.; Lyle Carol L author non-byline.; Mitchell Robert author non-byline.; Oeth Justin author non-byline.; Rice Erika LW author non-byline.; Robison Sarah W author non-byline.; Schick Alexandra author non-byline.; Stang Jamie author non-byline.; Walters Andrew M author non-byline.; Westphal Nathaniel D author non-byline.; Watase Tak author non-byline.; Lloyd Bradley author non-byline.; Krishnamoorthy Vijay author non-byline.; Bartz Raquel R author non-byline.; Fox William C author non-byline.; Whittle John author non-byline.; Alvis Bret D author non-byline.; Demasi Stephanie C author non-byline.; Goyack Laura E author non-byline.; Ford Kristy K author non-byline.; Mattox Trevor S author non-byline.; Altz-Stamm Anna author non-byline.; Bardita Cristina author non-byline.; Boone Mary Clay author non-byline.; Chiles Joe W author non-byline.; Collins Kristina author non-byline.; Drescher Abby author non-byline.; Dsouza Kevin G author non-byline.; Dunn Janna author non-byline.; Ejem Stacy author non-byline.; Gautney Josh author non-byline.; Harris Nicole author non-byline.; Herder Savannah author non-byline.; Hudali Tamer author non-byline.; Chad Wade R author non-byline.; Joshi Rutwij author non-byline.; Kelmenson Daniel author non-byline.; Mason Anne Merrill author non-byline.; Merriman Scott R author non-byline.; Mkorombindo Takudzwa author non-byline.; Moore Megan author non-byline.; Nowak Jada author non-byline.; O'Connor Kate author non-byline.; Patel Sheylan D author non-byline.; Bruno Pereira G author non-byline.; Sarratt Lisa author non-byline.; Stewart Tabitha author non-byline.; Stigler William S author non-byline.; Vijaykumar Kadambari author non-byline.; White Gina author non-byline.; Defebio Anthony author non-byline.; Friedel Jennifer author non-byline.; Mohamed Feysel author non-byline.; Nava Karina author non-byline.; Otoo Angela author non-byline.; Perez Christian author non-byline.; Withers Cori author non-byline.;
• Is Part Of: BMJ open. Volume 11:Issue 5(2021)
• Publication Date: 2021-05-25
• Subjects: adult intensive & critical care -- adult intensive & critical care -- intensive & critical care; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2020-047790
• Languages: English
• ISSNs: 2044-6055

Abstract

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 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 ).