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

Official title

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

Overview

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.

Interventions

• Procedure 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
• Procedure 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.

Primary outcome measures

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

Secondary outcome measures (12)

• Occurrence of hypoxia [Time frame: Within 1 hour following intubation]
• Occurrence of bradycardia [Time frame: Within 1 hour following intubation]
• Occurrence of cardiac arrest [Time frame: Within 1 hour following intubation]
• Occurrence of death [Time frame: Within 1 hour following intubation]
• Occurrence of pulmonary aspirations [Time frame: Within 1 hour following intubation]
• Occurrence of severe cardiovascular collapse [Time frame: Within 1 hour following intubation]
• Time between blade introduction to the confirmation of a correct tube placement [Time frame: 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 [Time frame: 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 [Time frame: Within 15 minutes following induction]
• Cormack-Lehane grade of glottic view at first intubation attempt [Time frame: Within 10 minutes following first blade introduction]
• Number of laryngoscopies attempts to achieve correct endotracheal tube placement [Time frame: 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 [Time frame: Within 30 minutes following first blade introduction]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

France · 10 centers

• 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
• … and 2 more centers

Publications

• 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

Identifiers

NCT: NCT06307392 · RC22_0393

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗