Acute Respiratory Failure Requiring IntubationBETANCT06307392
Bougie Versus Endotracheal Tube Alone on First-attempt Intubation Success in Prehospital Emergency Intubation (BETA Trial)
A study testing First intubation attempt with endotracheal tube plus bougie and First intubation attempt with endotracheal tube alone in people with Acute Respiratory Failure Requiring Intubation, run by Nantes University Hospital at 10 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure Requiring Intubation
- What is being tested?
- First intubation attempt with endotracheal tube plus bougie and First intubation attempt with endotracheal tube alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 710 participants
- Where
- 10 sitesFrance
- Study dates
- 26 Mar 2024to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Managed by a physician staffed mobile intensive care unit (MICU).
- With an indication of emergency prehospital endotracheal intubation.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
France10 sites, 10 recruiting
- Recruiting
CHU de Besançon
Besançon, 25000
Justin OUTREY, joutrey@chu-besancon.fr
Justin OUTREY
- Recruiting
CHU de Bordeaux
Bordeaux, 33000
Xavier COMBES, xavier.combes@chu-bordeaux.fr
Xavier COMBES
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
Jean-Baptiste BOUILLON, jbbouillon-minois@chu-clermontferrand.fr
Jean-Baptiste BOUILLON
- Recruiting
CHD La Roche sur Yon
La Roche-sur-Yon, 85925
Arthur SANDIJVY, arthur.sandjivy@ght85.fr
Arthur SANDIJVY
- Not yet recruiting
CH de Lorient
Lorient, 56100
Jules PERICHON, jules.perichon@gmail.com
Jules PERICHON
- Not yet recruiting
CHU de Lyon
Lyon, 69003
Youri YORDANOV, youri.yordanov@chu-lyon.fr
Youri YORDANOV
- Recruiting
CHU de Nancy
Nancy, 54000
Tahar CHOUIHED, T.CHOUIHEDMAHJOUB@chru-nancy.fr
Tahar CHOUIHED
- Recruiting
Nantes University Hospital
Nantes, Loire Atlantique, 44093
Quentin Le Bastard, MD, 0240087839, quentin.lebastard@chu-nantes.fr
Quentin Le Bastard, MD
- Recruiting
CHU de Poitiers
Poitiers, 86000
Nicolas MARJANOVIC, Nicolas.MARJANOVIC@chu-poitiers.fr
Nicolas MARJANOVIC
- Recruiting
CHU de Rennes
Rennes, 35000
Nicolas PESCHANSCKI, nicolas.peschanski@chu-rennes.fr
Nicolas PESCHANSCKI
About this study
Official title: 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.
- Being tested
- First intubation attempt with endotracheal tube plus bougie, First intubation attempt with endotracheal tube alone
- Keywords
- Bougie, Intubation, Acute Respiratory failure, Airway, Critical Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First intubation attempt with endotracheal tube plus bougieProcedure or surgery
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.
First intubation attempt with endotracheal tube aloneProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Endotracheal tube plus bougie | Experimental | Not described Receives: Procedure: First intubation attempt with endotracheal tube plus bougie |
| Endotracheal tube alone | Active comparator | Not described Receives: Procedure: First intubation attempt with endotracheal tube alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of first pass success during prehospital emergency intubation
Successful intubation on first attempt
Measured: Within 10 minutes following blade introduction
Secondary outcomes (16)
Occurrence of hypoxia
SpO2 (pulsed oxygen saturation) <90%
Measured: Within 1 hour following intubation
Occurrence of bradycardia
Heart rate <50 bpm
Measured: Within 1 hour following intubation
Occurrence of cardiac arrest
Measured: Within 1 hour following intubation
Occurrence of death
Measured: Within 1 hour following intubation
Occurrence of pulmonary aspirations
Measured: Within 1 hour following intubation
Occurrence of severe cardiovascular collapse
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
Measured: Within 1 hour following intubation
Time between blade introduction to the confirmation of a correct tube placement
In minutes. The correct position of the endotracheal tube is confirmed by detection of end-tidal carbon dioxide.
Measured: 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
In percentage
Measured: 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
Measured: Within 15 minutes following induction
Cormack-Lehane grade of glottic view at first intubation attempt
Measured: Within 10 minutes following first blade introduction
Number of laryngoscopies attempts to achieve correct endotracheal tube placement
Measured: 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
Measured: Within 30 minutes following first blade introduction
Difficulty perceived by the operator on first intubation attempt
3-point Likert scale
Measured: Within 10 minutes following blade introduction
Occurrence of injuries
Occurrence (yes/no) of injuries related to the intubation:
mucosal bleeding, laryngeal, tracheal, bronchial, mediastinal or oesophageal injuries
Measured: Within 24 hours following intubation
Occurrence of complications
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)
Measured: 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
SpO2/FiO2 collected every 10 minutes to determine the minimum ratio
Measured: Within one hour after confirmation of correct tube placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start26 Mar 2024
- Primary completion26 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Failure Requiring IntubationStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 710 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Quentin LE BASTARD, MD, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06307392
- Sponsor's protocol ID
- RC22_0393
- Acronym
- BETA
- Status last verified
- Jan 2026
- First submitted
- 6 Mar 2024
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40890804
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bougie Versus Endotracheal Tube Alone on First-attempt Intubation Success in Prehospital Emergency Intubation in Patients Without Predictors of Difficult Intubation (BETA Trial)
- ClinicalTrials.gov ID
- NCT06307392
- Acronym / sponsor ID
- BETA / RC22_0393
- Keywords
- Bougie, Intubation, Acute Respiratory failure, Airway, Critical Care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 710 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 26 Mar 2024 (actual)
- Primary completion
- 26 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Managed by a physician staffed mobile intensive care unit (MICU).
- With an indication of emergency prehospital endotracheal intubation.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| First intubation attempt with endotracheal tube plus bougieUse 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. | Procedure or surgery | Endotracheal tube plus bougie |
| First intubation attempt with endotracheal tube aloneDuring 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. | Procedure or surgery | Endotracheal tube alone |
Primary outcome
Number of first pass success during prehospital emergency intubation
Time frame: Within 10 minutes following blade introduction
Successful intubation on first attempt
16 secondary outcomes
Occurrence of hypoxia
Time frame: Within 1 hour following intubation
Occurrence of bradycardia
Time frame: Within 1 hour following intubation
Occurrence of cardiac arrest
Time frame: Within 1 hour following intubation
Occurrence of death
Time frame: Within 1 hour following intubation
Occurrence of pulmonary aspirations
Time frame: Within 1 hour following intubation
Occurrence of severe cardiovascular collapse
Time frame: 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
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
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
Cormack-Lehane grade of glottic view at first intubation attempt
Time frame: 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
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
Difficulty perceived by the operator on first intubation attempt
Time frame: Within 10 minutes following blade introduction
Occurrence of injuries
Time frame: Within 24 hours following intubation
Occurrence of complications
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Derived from this study: PubMed 40890804Le 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Quentin LE BASTARD, MD principal investigator
Nantes University Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing First intubation attempt with endotracheal tube plus bougie and First intubation attempt with endotracheal tube alone in people with Acute Respiratory Failure Requiring Intubation, run by Nantes University Hospital at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Quentin LE BASTARD, MD (0240087839, quentin.lebastard@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of first pass success during prehospital emergency intubation (time frame: Within 10 minutes following blade introduction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06307392, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.