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

January 22, 2026 updated by: Nantes University Hospital

Bougie Versus Endotracheal Tube Alone on First-attempt Intubation Success in Prehospital Emergency Intubation in Patients Without Predictors of Difficult Intubation (BETA Trial)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

710

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Besançon, France, 25000
        • Recruiting
        • CHU de Besançon
        • Principal Investigator:
          • Justin Outrey
        • Contact:
      • Bordeaux, France, 33000
      • Clermont-Ferrand, France, 63000
      • La Roche-sur-Yon, France, 85925
        • Recruiting
        • CHD La Roche sur Yon
        • Contact:
        • Principal Investigator:
          • Arthur SANDIJVY
      • Lorient, France, 56100
        • Not yet recruiting
        • CH de Lorient
        • Contact:
        • Principal Investigator:
          • Jules PERICHON
      • Lyon, France, 69003
      • Nancy, France, 54000
      • Poitiers, France, 86000
      • Rennes, France, 35000
    • Loire Atlantique
      • Nantes, Loire Atlantique, France, 44093
        • Recruiting
        • Nantes University Hospital
        • Contact:
        • Principal Investigator:
          • Quentin Le Bastard, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Endotracheal tube plus bougie
Procedure: 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.
Active Comparator: Endotracheal tube alone
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of first pass success during prehospital emergency intubation
Time Frame: Within 10 minutes following blade introduction
Successful intubation on first attempt
Within 10 minutes following blade introduction

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of hypoxia
Time Frame: Within 1 hour following intubation
SpO2 (pulsed oxygen saturation) <90%
Within 1 hour following intubation
Occurrence of bradycardia
Time Frame: Within 1 hour following intubation
Heart rate <50 bpm
Within 1 hour following intubation
Occurrence of cardiac arrest
Time Frame: Within 1 hour following intubation
Within 1 hour following intubation
Occurrence of death
Time Frame: Within 1 hour following intubation
Within 1 hour following intubation
Occurrence of pulmonary aspirations
Time Frame: Within 1 hour following intubation
Within 1 hour following intubation
Occurrence of severe cardiovascular collapse
Time Frame: Within 1 hour following intubation
Systolic blood pressure less than 65mmHg recorded at least once or less than 90 mmHg lasting 30 minutes despite 500-1,000 ml of fluid loading (crystalloids) or requiring introduction or increasing doses by more than 30% of vasoactive support
Within 1 hour following intubation
Time between blade introduction to the confirmation of a correct tube placement
Time Frame: Within 15 minutes following blade introduction
In minutes. The correct position of the endotracheal tube is confirmed by detection of end-tidal carbon dioxide.
Within 15 minutes following blade introduction
Change in SpO2 (pulsed oxygen saturation) from the time of induction to lowest SpO2 up to 2 minutes after confirmation of correct tube placement
Time Frame: Within 15 minutes following induction
In percentage
Within 15 minutes following induction
Occurrence of change in SpO2 of more than 3% from the time of induction to 2 minutes after confirmation of correct tube placement
Time Frame: Within 15 minutes following induction
Within 15 minutes following induction
Cormack-Lehane grade of glottic view at first intubation attempt
Time Frame: Within 10 minutes following first blade introduction
Within 10 minutes following first blade introduction
Number of laryngoscopies attempts to achieve correct endotracheal tube placement
Time Frame: Within 30 minutes following first blade introduction
Within 30 minutes following first blade introduction
Number of patients for whom the placement of an endotracheal tube was not possible in the pre-hospital setting
Time Frame: Within 30 minutes following first blade introduction
Within 30 minutes following first blade introduction
Difficulty perceived by the operator on first intubation attempt
Time Frame: Within 10 minutes following blade introduction
3-point Likert scale
Within 10 minutes following blade introduction
Occurrence of injuries
Time Frame: Within 24 hours following intubation

Occurrence (yes/no) of injuries related to the intubation:

mucosal bleeding, laryngeal, tracheal, bronchial, mediastinal or oesophageal injuries
Within 24 hours following intubation
Occurrence of complications
Time Frame: Within 48 hours following intubation

Occurrence (yes/no) of complications related to the intubation:

aspiration pneumonia (new opacity on chest imaging within 48 hours after intubation, in comparison to the first chest imaging after hospital admission), pneumothorax (new air collection within the pleural cavity on chest imaging)
Within 48 hours following intubation
Change of SpO2/FiO2 ratio (pulsed oxygen saturation / fraction of inspired oxygen) between the time of confirmation of correct tube placement and the minimum ratio
Time Frame: Within one hour after confirmation of correct tube placement
SpO2/FiO2 collected every 10 minutes to determine the minimum ratio
Within one hour after confirmation of correct tube placement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

  • Principal Investigator: Quentin LE BASTARD, MD, Nantes University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 26, 2024

Primary Completion (Estimated)

March 26, 2027

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

March 6, 2024

First Submitted That Met QC Criteria

March 6, 2024

First Posted (Actual)

March 12, 2024

Study Record Updates

Last Update Posted (Actual)

January 23, 2026

Last Update Submitted That Met QC Criteria

January 22, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC22_0393

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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