Comparing bougie-assisted intubation to standard intubation in emergency settings
Bougie Versus Endotracheal Tube Alone on First-attempt Intubation Success in Prehospital Emergency Intubation in Patients Without Predictors of Difficult Intubation (BETA Trial)
This study tests if using a bougie with an endotracheal tube during emergency intubation helps patients have a safer and more successful experience compared to using the tube alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 710 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nantes University Hospital Academic / other |
| Locations | 10 sites (Nantes, Loire Atlantique and 9 other locations) |
| Trial ID | NCT06307392 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effectiveness of using a bougie alongside an endotracheal tube during the first attempt at intubation in prehospital emergency situations. It aims to address the challenges faced in emergency intubation, such as the risk of complications and the lower success rates compared to in-hospital settings. By comparing two approaches—intubation with a bougie versus intubation with an endotracheal tube alone—the study seeks to improve the safety and efficiency of airway management in critical care. The trial is conducted by a physician-staffed mobile intensive care unit, focusing on patients requiring emergency intubation.
Who should consider this trial
Good fit: Ideal candidates are patients requiring emergency prehospital endotracheal intubation managed by a physician-staffed mobile intensive care unit.
Not a fit: Patients with predictors of difficult intubation or those with a 'not to be resuscitated' indication may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the success rate of first-attempt intubations in emergency settings, reducing complications and improving patient outcomes.
How similar studies have performed: Previous studies have indicated that the use of assistive devices like bougies may improve intubation success rates, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nantes, Loire Atlantique and 9 other locations
- Nantes University Hospital — Nantes, Loire Atlantique, France (Recruiting)
- CHU de Besançon — Besançon, France (Recruiting)
- CHU de Bordeaux — Bordeaux, France (Recruiting)
- CHU de Clermont-Ferrand — Clermont-Ferrand, France (Recruiting)
- CHD La Roche sur Yon — La Roche-sur-Yon, France (Recruiting)
- CH de Lorient — Lorient, France (Not_yet_recruiting)
- CHU de Lyon — Lyon, France (Not_yet_recruiting)
- CHU de Nancy — Nancy, France (Recruiting)
- CHU de Poitiers — Poitiers, France (Recruiting)
- CHU de Rennes — Rennes, France (Recruiting)
Study contacts
- Principal investigator: Quentin LE BASTARD, MD — Nantes University Hospital
- Study coordinator: Quentin LE BASTARD, MD
- Email: quentin.lebastard@chu-nantes.fr
- Phone: 0240087839
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.