Trials · 2025
Bougie versus endotracheal tube alone on first-attempt intubation success in prehospital emergency intubation in patients without predictors of difficult intubation: protocol for the BETA randomized controlled trial.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
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Le Bastard Quentin, Jenvrin Joel, Gaultier Aurélie, Montassier Emmanuel
Аннотация
BACKGROUND: Prehospital airway management is a critical and high-risk procedure in emergency medicine. First-pass intubation success is essential to reduce complications such as hypoxemia, aspiration, and hemodynamic instability. Although the bougie is commonly used in inhospital settings for difficult intubations, its routine use in first-attempt prehospital intubation in patients without difficult airway predictors has not been evaluated in randomized controlled trials.
METHODS: The BETA study is a multicenter, randomized, controlled, single-blinded superiority trial comparing bougie-assisted intubation with standard endotracheal tube intubation in adult patients (≥ 18 years) requiring prehospital intubation without predictors of difficult airway. A total of 710 participants will be randomized (1:1) across 10 French mobile intensive care units (MICUs). The primary outcome is first-attempt intubation success. Secondary outcomes include adverse events, glottic view, procedure duration, desaturation, perceived difficulty, and airway injuries. Data will be analyzed using logistic regression with a mixed model.
DISCUSSION: This trial will be the first to assess whether the routine use of a bougie improves first-attempt intubation success in prehospital settings. If successful, the intervention could shape future airway management practices.
TRIAL REGISTRATION: ClinicalTrials.gov NCT06307392. Registered on March 26, 2024.
METHODS: The BETA study is a multicenter, randomized, controlled, single-blinded superiority trial comparing bougie-assisted intubation with standard endotracheal tube intubation in adult patients (≥ 18 years) requiring prehospital intubation without predictors of difficult airway. A total of 710 participants will be randomized (1:1) across 10 French mobile intensive care units (MICUs). The primary outcome is first-attempt intubation success. Secondary outcomes include adverse events, glottic view, procedure duration, desaturation, perceived difficulty, and airway injuries. Data will be analyzed using logistic regression with a mixed model.
DISCUSSION: This trial will be the first to assess whether the routine use of a bougie improves first-attempt intubation success in prehospital settings. If successful, the intervention could shape future airway management practices.
TRIAL REGISTRATION: ClinicalTrials.gov NCT06307392. Registered on March 26, 2024.