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

Nantes University Hospital (NUH)

Status: Enrolling

Conditions: Acute Respiratory Failure Requiring Intubation

Treatments: Procedure: First intubation attempt with endotracheal tube alone; Procedure: First intubation attempt with endotracheal tube plus bougie

Study type: Interventional

Funder types: Other

Identifiers

NCT06307392

RC22_0393

Details and patient eligibility

About

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.

Enrollment: 710 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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710 participants in 2 patient groups

Endotracheal tube plus bougie

Experimental group

Treatment:

Procedure: First intubation attempt with endotracheal tube plus bougie

Endotracheal tube alone

Active Comparator group

Treatment:

Procedure: First intubation attempt with endotracheal tube alone