Effect of Use of a Bougie vs Endotracheal Tube With Stylet on Successful Intubation on the First Attempt Among Critically Ill Patients Undergoing Tracheal Intubation: A Randomized Clinical Trial

Abstract

Importance: For 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.

Objective: To determine the effect of use of a bougie vs an endotracheal tube with stylet on successful intubation on the first attempt.

Design, setting, and participants: The 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.

Interventions: Patients were randomly assigned to use of a bougie (n = 556) or use of an endotracheal tube with stylet (n = 546).

Main outcomes and measures: The 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%.

Results: Among 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 relevance: Among 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 registration: ClinicalTrials.gov Identifier: NCT03928925

Figure 1.. Flow of Participants Through the Trial

ED indicates emergency department; ICU, intensive care unit. ^aAmong 77 patients intubated with a hyperangulated laryngoscope, 32 were at a single trial site at which operators preferred a hyperangulated blade when video laryngoscopy was to be performed. The indication for the selection of a hyperangulated blade for the remaining 45 patients was not recorded. ^bAmong 282 patients who underwent intubation too urgently to complete trial procedures, 28 were at trial sites that recorded the reason for the urgency. Of these, 17 patients were experiencing cardiac arrest, 3 had ongoing hematemesis, 3 had severe hypoxemia, 1 had an acute cerebrovascular accident requiring urgent transport, 1 had massive hemoptysis, 1 had a tension pneumothorax, 1 was experiencing a seizure, and 1 had a traumatic injury requiring an emergency procedure. ^cReasons a bougie was required: 3 patients with a history of a prior difficult intubation, 3 with body fluids obscuring the glottic view, 1 with morbid obesity, and 7 with unknown reason. ^dReasons a bougie was contraindicated: 1 patient with recent lung transplant and concern for damage to the anastomoses; 2 with unknown reason.

Figure 2.. Subgroup Analysis of the Primary Outcome

Shown are the odds ratios and 95% CIs for the primary outcome in the bougie group compared with the stylet group, after adjustment for prespecified baseline covariates. The Cormack-Lehane grade of glottic view ranges from grade 1 (all or most of the glottic opening is seen) to grade 4 (neither glottis nor epiglottis are seen). The prespecified difficult airway characteristics included in this effect modification analysis were obesity (body mass index >30 [calculated as weight in kilograms divided by height in meters squared]), cervical immobilization, and facial trauma. ED indicates emergency department; ICU, intensive care unit.