Bougie Versus Endotracheal Tube Alone on First-attempt Intubation Success in Prehospital Emergency Intubation (BETA Trial)
Recruiting now · Not applicable
Conditions studied: Acute Respiratory Failure Requiring Intubation
In brief
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.
Key facts
- Study ID
- NCT06307392
- Run by
- Nantes University Hospital
- People needed
- 710
- Starts
- 2024-03-26
- Expected to finish
- 2027-03-31
- Last updated by the study team
- 2026-01-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Managed by a physician staffed mobile intensive care unit (MICU).
- With an indication of emergency prehospital endotracheal intubation.
You may not qualify if…
- 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.
Where it is running
- Nantes University Hospital — Nantes, Loire Atlantique, France (enrolling)
- CHU de Besançon — Besançon, France (enrolling)
- CHU de Bordeaux — Bordeaux, France (enrolling)
- CHU de Clermont-Ferrand — Clermont-Ferrand, France (enrolling)
- CHD La Roche sur Yon — La Roche-sur-Yon, France (enrolling)
- CHU de Poitiers — Poitiers, France (enrolling)
- CHU de Rennes — Rennes, France (enrolling)
- CHU de Nancy — Nancy, France (enrolling)
- CH de Lorient — Lorient, France
- CHU de Lyon — Lyon, France
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.