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

NCT ID: NCT06307392

Last Updated: 2024-04-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 710 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-26
• Study Completion Date: 2027-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Endotracheal tube plus bougie

Group Type: EXPERIMENTAL

First intubation attempt with endotracheal tube plus bougie

Intervention Type: 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 alone

Group Type: ACTIVE_COMPARATOR

First intubation attempt with endotracheal tube alone

Intervention Type: 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.

Interventions

First intubation attempt with endotracheal tube plus bougie

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.

Intervention Type: PROCEDURE

First intubation attempt with endotracheal tube alone

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Quentin LE BASTARD, MD

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

Nantes University Hospital

Nantes, Loire Atlantique, France

Site Status: RECRUITING

Countries

France

Central Contacts

Quentin LE BASTARD, MD

Role: CONTACT

quentin.lebastard@chu-nantes.fr

0240087839

Facility Contacts

Quentin Le Bastard, MD

Role: primary

quentin.lebastard@chu-nantes.fr

0240087839

References

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.

Reference Type: DERIVED

PMID: 40890804 (View on PubMed)

Other Identifiers

RC22_0393

Identifier Type: -

Identifier Source: org_study_id