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

NCT06307392 | Recruiting DMC

• 1 other identifier: RC22_0393
• Study Type: interventional
• Target: 710
• Locations: 1 country
• Sites: 10

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.

Conditions

Acute Respiratory Failure Requiring Intubation

Keywords

Bougie; Intubation; Acute Respiratory failure; Airway; Critical Care

Outcome Measures

Primary Outcomes (1)

• Number of first pass success during prehospital emergency intubation

  Successful intubation on first attempt

  Within 10 minutes following blade introduction

Secondary Outcomes (16)

• Occurrence of hypoxia

  Within 1 hour following intubation

• Occurrence of bradycardia

  Within 1 hour following intubation

• Occurrence of cardiac arrest

  Within 1 hour following intubation

• Occurrence of death

  Within 1 hour following intubation

• Occurrence of pulmonary aspirations

  Within 1 hour following intubation

Study Arms (2)

Endotracheal tube plus bougie

EXPERIMENTAL

Procedure: First intubation attempt with endotracheal tube plus bougie

Endotracheal tube alone

ACTIVE COMPARATOR

Procedure: First intubation attempt with endotracheal tube alone

Interventions

First intubation attempt with endotracheal tube plus bougie PROCEDURE

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 manually stabilize the bougie. Once the bougie has reached the mouth, the assistant will then stabilize the bougie, and 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. Then, the assistant will withdraw the bougie from the endotracheal tube. The use of a stylet is not permitted.

Endotracheal tube plus bougie

First intubation attempt with endotracheal tube alone PROCEDURE

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.

Endotracheal tube alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (10)

Nantes University Hospital

Nantes, Loire Atlantique, 44093, France

RECRUITING

CHU de Besançon

Besançon, 25000, France

RECRUITING

CHU de Bordeaux

Bordeaux, 33000, France

RECRUITING

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

RECRUITING

CHD La Roche sur Yon

La Roche-sur-Yon, 85925, France

RECRUITING

CH de Lorient

Lorient, 56100, France

NOT YET RECRUITING

CHU de Lyon

Lyon, 69003, France

NOT YET RECRUITING

CHU de Nancy

Nancy, 54000, France

RECRUITING

CHU de Poitiers

Poitiers, 86000, France

RECRUITING

CHU de Rennes

Rennes, 35000, France

RECRUITING

Related Publications (1)

• 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 DERIVED

Study Officials

• Quentin LE BASTARD, MD

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Quentin LE BASTARD, MD

CONTACT

0240087839; quentin.lebastard@chu-nantes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 12, 2024
• Study Start: March 26, 2024
• Primary Completion (Estimated): March 26, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

FR (10)