Dataset Information

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

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).

SUBMITTER: Driver B

PROVIDER: S-EPMC8154972 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Importance:The tracheal tube introducer, known as the bougie, is typically used to aid tracheal intubation in poor laryngoscopic views or after intubation attempts fail. The effect of routine bougie use on first-attempt intubation success is unclear. Objective:To compare first attempt intubation success facilitated by the bougie vs the endotracheal tube + stylet. Design, Setting, and Patients:The Bougie Use in Emergency Airway Management (BEAM) trial was a randomized clinical trial conducted from September 2016 through August 2017 in the emergency department at Hennepin County Medical Center, an urban, academic department in Minneapolis, Minnesota, where emergency physicians perform all endotracheal intubations. Included patients were 18 years and older who were consecutively admitted to the emergency department and underwent emergency orotracheal intubation with a Macintosh laryngoscope blade for respiratory arrest, difficulty breathing, or airway protection. Interventions:Patients were randomly assigned to undergo the initial intubation attempt facilitated by bougie (n = 381) or endotracheal tube + stylet (n = 376). Main Outcomes and Measures:The primary outcome was first-attempt intubation success in patients with at least 1 difficult airway characteristic (body fluids obscuring the laryngeal view, airway obstruction or edema, obesity, short neck, small mandible, large tongue, facial trauma, or the need for cervical spine immobilization). Secondary outcomes were first-attempt success in all patients, first-attempt intubation success without hypoxemia, first-attempt duration, esophageal intubation, and hypoxemia. Results:Among 757 patients who were randomized (mean age, 46 years; women, 230 [30%]), 757 patients (100%) completed the trial. Among the 380 patients with at least 1 difficult airway characteristic, first-attempt intubation success was higher in the bougie group (96%) than in the endotracheal tube + stylet group (82%) (absolute between-group difference, 14% [95% CI, 8% to 20%]). Among all patients, first-attempt intubation success in the bougie group (98%) was higher than the endotracheal tube + stylet group (87%) (absolute difference, 11% [95% CI, 7% to 14%]). The median duration of the first intubation attempt (38 seconds vs 36 seconds) and the incidence of hypoxemia (13% vs 14%) did not differ significantly between the bougie and endotracheal tube + stylet groups. Conclusions and Relevance:In this emergency department, use of a bougie compared with an endotracheal tube + stylet resulted in significantly higher first-attempt intubation success among patients undergoing emergency endotracheal intubation. However, these findings should be considered provisional until the generalizability is assessed in other institutions and settings. Trial Registration:clinicaltrials.gov Identifier: NCT02902146.

Project description:ImportanceFor critically ill adults undergoing emergency tracheal intubation, failure to intubate the trachea on the first attempt occurs in up to 20% of cases and is associated with severe hypoxemia and cardiac arrest. Whether using a tracheal tube introducer ("bougie") increases the likelihood of successful intubation compared with using an endotracheal tube with stylet remains uncertain.ObjectiveTo determine the effect of use of a bougie vs an endotracheal tube with stylet on successful intubation on the first attempt.Design, setting, and participantsThe Bougie or Stylet in Patients Undergoing Intubation Emergently (BOUGIE) trial was a multicenter, randomized clinical trial among 1102 critically ill adults undergoing tracheal intubation in 7 emergency departments and 8 intensive care units in the US between April 29, 2019, and February 14, 2021; the date of final follow-up was March 14, 2021.InterventionsPatients were randomly assigned to use of a bougie (n = 556) or use of an endotracheal tube with stylet (n = 546).Main outcomes and measuresThe primary outcome was successful intubation on the first attempt. The secondary outcome was the incidence of severe hypoxemia, defined as a peripheral oxygen saturation less than 80%.ResultsAmong 1106 patients randomized, 1102 (99.6%) completed the trial and were included in the primary analysis (median age, 58 years; 41.0% women). Successful intubation on the first attempt occurred in 447 patients (80.4%) in the bougie group and 453 patients (83.0%) in the stylet group (absolute risk difference, -2.6 percentage points [95% CI, -7.3 to 2.2]; P = .27). A total of 58 patients (11.0%) in the bougie group experienced severe hypoxemia, compared with 46 patients (8.8%) in the stylet group (absolute risk difference, 2.2 percentage points [95% CI, -1.6 to 6.0]). Esophageal intubation occurred in 4 patients (0.7%) in the bougie group and 5 patients (0.9%) in the stylet group, pneumothorax was present after intubation in 14 patients (2.5%) in the bougie group and 15 patients (2.7%) in the stylet group, and injury to oral, glottic, or thoracic structures occurred in 0 patients in the bougie group and 3 patients (0.5%) in the stylet group.Conclusions and relevanceAmong critically ill adults undergoing tracheal intubation, use of a bougie did not significantly increase the incidence of successful intubation on the first attempt compared with use of an endotracheal tube with stylet.Trial registrationClinicalTrials.gov Identifier: NCT03928925

Project description:BACKGROUND:Incidence of difficult endotracheal intubation ranges between 3 and 10%. Bougies have been recommended as an airway adjunct for difficult intubation, but reported success rates are variable. A new generation flexible tip bougie appears promising but was not investigated so far. We therefore compared the new flexible tip with a standard bougie in simulated normal and difficult airway scenarios, and used by experienced anesthesiologists. METHODS:We conducted a observational, randomized, cross-over simulation study. Following standardized training, experienced anesthesiologists performed endotracheal intubation using a Macintosh blade and one of the bougies in six different airway scenarios in a randomized sequence: normal airway, tongue edema, pharyngeal obstruction, manual cervical inline stabilization, cervical collar stabilization, cervical collar stabilization and pharyngeal obstruction. Overall success rate with a maximum of 3 intubation attempts was the primary endpoint. Secondary endpoints included number of intubation attempts, time to intubation and dental compression. RESULTS:Thirty-two anesthesiologist participated in this study between January 2019 and May 2019. Overall success rate was similar for the flexible tip bougie and the standard bougie. The flexible tip bougie tended to need less intubation attempts in more difficult airway scenarios. Time to intubation was less if using the flexible tip bougie compared to the standard bougie. Reduced severity of dental compression was noted for the flexible tip bougie in difficult airway scenarios except cervical collar stabilization. CONCLUSION:In this simulation study of normal and difficult airways scenarios, overall success rate was similar for the flexible tip and standard bougie. Especially in more difficult airway scenarios, less intubation attempts, and less optimization maneuvers were needed if using the flexible tip bougie. TRIAL REGISTRATION:clinicaltrials.gov Identifier: NCT03733158. 7th November 2018.

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