Bougie Versus Endotracheal Tube Alone on First-attempt Intubation Success in Prehospital Emergency Intubation (BETA Trial)

Официальное название

Bougie Versus Endotracheal Tube Alone on First-attempt Intubation Success in Prehospital Emergency Intubation in Patients Without Predictors of Difficult Intubation (BETA Trial)

Обзор

Emergency intubation is routinely performed in the prehospital setting. Airway management in the prehospital setting has substantial challenges, such as hostile environment or lack of technical support in case of first attempt intubation failure, and inherent risk of complications, such as hypoxemia, aspiration or oesophageal intubation. This risk is higher when several attempts are needed to succeed endotracheal intubation. Thus, a successful first attempt intubation is highly desirable to avoid adverse intubation-related events. Noteworthy, prehospital emergency intubation is associated with a lower rate of first attempt intubation success when compared to emergency intubation in the emergency department (ED). Research is needed to overcome the specific challenges of airway management in the prehospital setting, and to improve the safety and efficiency of prehospital emergency intubation. Literature reports that the use of assistive devices such as bougie may increase the rate of first-attempt intubation success in the ED. To date, no randomized trial has ever studied this device in the prehospital setting. Thus, the aim of the BETA trial is to compare first attempt intubation success facilitated by the bougie versus the endotracheal tube alone in the prehospital setting.

Вмешательства

• Процедура First intubation attempt with endotracheal tube plus bougie
  Use of a straight, malleable, semirigid bougie on first-attempt intubation. The required bougie is at least 60cm length, a coudé tip is recommended but not required. Operator may choose whether to bend the bougie prior to intubation. During laryngoscopy, the operator will insert the bougie into the trachea under direct or indirect visual control. If the bougie is successfully placed in the trachea, an assistant will load the endotracheal tube directly over the bougie while the operator will man
• Процедура First intubation attempt with endotracheal tube alone
  During laryngoscopy, the operator will insert the endotracheal tube alone into the trachea under direct or indirect visual control. The operator will advance the tube through the vocal cords to the adequate depth in the trachea, without removing the laryngoscope from the mouth. The operator will inflate the cuff and manually stabilize the tube. The use of a stylet is not permitted.

Первичные конечные точки

• Number of first pass success during prehospital emergency intubation [Срок оценки: Within 10 minutes following blade introduction]

Вторичные конечные точки (12)

• Occurrence of hypoxia [Срок оценки: Within 1 hour following intubation]
• Occurrence of bradycardia [Срок оценки: Within 1 hour following intubation]
• Occurrence of cardiac arrest [Срок оценки: Within 1 hour following intubation]
• Occurrence of death [Срок оценки: Within 1 hour following intubation]
• Occurrence of pulmonary aspirations [Срок оценки: Within 1 hour following intubation]
• Occurrence of severe cardiovascular collapse [Срок оценки: Within 1 hour following intubation]
• Time between blade introduction to the confirmation of a correct tube placement [Срок оценки: Within 15 minutes following blade introduction]
• Change in SpO2 (pulsed oxygen saturation) from the time of induction to lowest SpO2 up to 2 minutes after confirmation of correct tube placement [Срок оценки: Within 15 minutes following induction]
• Occurrence of change in SpO2 of more than 3% from the time of induction to 2 minutes after confirmation of correct tube placement [Срок оценки: Within 15 minutes following induction]
• Cormack-Lehane grade of glottic view at first intubation attempt [Срок оценки: Within 10 minutes following first blade introduction]
• Number of laryngoscopies attempts to achieve correct endotracheal tube placement [Срок оценки: Within 30 minutes following first blade introduction]
• Number of patients for whom the placement of an endotracheal tube was not possible in the pre-hospital setting [Срок оценки: Within 30 minutes following first blade introduction]

Критерии участия

Критерии включения

• Managed by a physician staffed mobile intensive care unit (MICU).
• With an indication of emergency prehospital endotracheal intubation.

Критерии исключения

• Pregnant women
• Patients with a "not to be resuscitated" indication.
• Patients with predictors of difficult intubation (that can be collected in the prehospital setting, including previous history of face, neck, throat surgery or pathology, limited mandibular protrusion, cervical spine trauma, facial trauma, ear-nose-throat malignancy, head or neck burns, history of previous difficult airways) for whom the use of a bougie is indicated on first intubation attempt.
• Patients under guardianship, trusteeship or safeguard of justice and patients with no health insurance.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Франция · 10 центров

• Nantes University Hospital — Nantes
• CHU de Besançon — Besançon
• CHU de Bordeaux — Bordeaux
• CHU de Clermont-Ferrand — Clermont-Ferrand
• CHD La Roche sur Yon — La Roche-sur-Yon
• CH de Lorient — Lorient
• CHU de Lyon — Lyon
• CHU de Nancy — Nancy
• … и ещё 2 центра

Публикации

• Le Bastard Q, Jenvrin J, Gaultier A, Montassier E. 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. Trials. 2025 Sep 1;26(1):327. doi: 10.1186/s13063-025-09046-8. PMID 40890804

Идентификаторы

NCT: NCT06307392 · RC22_0393

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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