NCT07422467

Bougie Use for Improving First-Pass Success in Novice Intubators

Should the Bougie be Standard Practice for Novice Intubators? A Randomized Cross-Over Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: Marmara University Pendik Training and Research Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

This was a prospective, randomized cross-over manikin study in which participants first completed a standardized two-hour theoretical and hands-on training session on airway anatomy, laryngoscopy techniques, and the use of stylet and bougie. Each participant subsequently performed four intubation techniques -direct and video laryngoscopy, each combined with either a stylet or a bougie- according to a randomized sequence on the same airway manikin using a 7.5-mm endotracheal tube. The primary outcome was first-pass success, defined as successful tracheal tube placement on the first attempt. The secondary outcome was intubation time, measured from initial contact of the laryngoscope blade with the manikin to successful advancement and release of the tube; attempts exceeding five minutes were classified as failed first-pass attempts.

Detailed description

Airway management is a fundamental emergency medicine skill, and first-pass success in endotracheal intubation (ETI) is strongly operator-dependent. Novice intubators have lower success rates and a higher risk of complications, making the identification of simple and effective adjuncts essential in training environments. Although devices such as the bougie, stylet, and video laryngoscope are widely used, the most suitable combination for beginners remains uncertain. To address this, a controlled simulation study was conducted under standardized conditions. This was a single-center, prospective, randomized cross-over manikin study conducted between April and July 2025 following ethics approval and written informed consent. Sixth-year medical students without prior real-world intubation experience were enrolled. Before the study procedures, all participants completed a standardized two-hour training session consisting of theoretical instruction and hands-on practice delivered in small groups by an emergency medicine specialist. Training focused on airway anatomy, laryngoscopy technique, and the correct use of both stylet and bougie, using the same airway manikin model employed in the study. Participants were randomly assigned in a 1:1:1:1 ratio to one of four sequence groups using a computer-based online randomization tool. Each group followed a predefined order of four techniques-direct laryngoscopy with bougie (DL+B), direct laryngoscopy with stylet (DL+S), video laryngoscopy with bougie (VL+B), and video laryngoscopy with stylet (VL+S)-so that every participant performed all techniques once while minimizing order and learning effects associated with repeated attempts. Group allocation was determined before the session, and all intubations were performed according to the assigned sequence. Intubation attempts were performed on a human airway manikin using a Macintosh size 3 blade for direct laryngoscopy and an i-view disposable video laryngoscope for video laryngoscopy. A 7.5-mm endotracheal tube was used in all attempts, and either a stylet or a bougie was applied according to the allocated technique. A 10-minute rest period was provided between attempts to reduce fatigue-related bias. The primary outcome was first-pass success, defined as successful placement of the endotracheal tube into the trachea on the first attempt. The secondary outcome was intubation time, measured from the moment the laryngoscope blade first contacted the manikin to the moment the endotracheal tube was successfully advanced into the trachea and released, as confirmed by study observers. Attempts lasting longer than five minutes were classified as failed first-pass attempts.

Conditions

• Endotracheal Intubation
• Novice Doctor

Interventions

Type	Name	Description
OTHER	video laryngoscope+ bougie,	All novice intubators performed these four intubation techniques in different sequences depending on the group allocation.
OTHER	direct laryngoscope+ bougie	All novice intubators in Group A performed, in sequence, video laryngoscope with bougie, direct laryngoscope with bougie, video laryngoscope with stylet, and direct laryngoscope with stylet.
OTHER	video laryngoscope+stylet	All novice intubators in Group A performed, in sequence, video laryngoscope with bougie, direct laryngoscope with bougie, video laryngoscope with stylet, and direct laryngoscope with stylet.
OTHER	direct laryngoscope+stylet	All novice intubators in Group A performed, in sequence, video laryngoscope with bougie, direct laryngoscope with bougie, video laryngoscope with stylet, and direct laryngoscope with stylet.

Timeline

• Start date: 2025-05-01
• Primary completion: 2025-08-10
• Completion: 2025-08-10
• First posted: 2026-02-20
• Last updated: 2026-02-20

Locations

1 site across 1 country: Turkey (Türkiye)