NCT06307392 Bougie Versus Endotracheal Tube Alone on First-attempt Intubation Success in Prehospital Emergency Intubation (BETA Trial)
| NCT ID | NCT06307392 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nantes University Hospital |
| Condition | Acute Respiratory Failure Requiring Intubation |
| Study Type | INTERVENTIONAL |
| Enrollment | 710 participants |
| Start Date | 2024-03-26 |
| Primary Completion | 2027-03-26 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 710 participants in total. It began in 2024-03-26 with a primary completion date of 2027-03-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Quentin LE BASTARD, MD
PRINCIPAL INVESTIGATOR
Nantes University Hospital
Frequently Asked Questions
Who can join the NCT06307392 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Respiratory Failure Requiring Intubation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06307392 currently recruiting?
Yes, NCT06307392 is actively recruiting participants. Contact the research team at quentin.lebastard@chu-nantes.fr for enrollment information.
Where is the NCT06307392 trial being conducted?
This trial is being conducted at Nantes, France, Besançon, France, Bordeaux, France, Clermont-Ferrand, France and 6 additional locations.
Who is sponsoring the NCT06307392 clinical trial?
NCT06307392 is sponsored by Nantes University Hospital. The principal investigator is Quentin LE BASTARD, MD at Nantes University Hospital. The trial plans to enroll 710 participants.