Endotracheal IntubationNCT07422467
Bougie Use for Improving First-Pass Success in Novice Intubators
A study testing video laryngoscope+ bougie,, direct laryngoscope+ bougie and video laryngoscope+stylet in people with Endotracheal Intubation and Novice Doctor, run by Marmara University Pendik Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This was a prospective, randomized cross-over manikin study in which participants first completed a standardized two-hour theoretical and hands-on training session on airway anatomy, laryngoscopy techniques, and the use of stylet and bougie. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Endotracheal Intubation, Novice Doctor
- What is being tested?
- video laryngoscope+ bougie,, direct laryngoscope+ bougie and video laryngoscope+stylet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2025to 10 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Sixth-year medical students
- Not on clinical duty at the time of participation
- No scheduled clinical duty on the following day
- Free of any acute illness at the time of the study
Who cannot join
- Any prior real-world experience in endotracheal intubation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University Pendik Training and Research Hospital
Istanbul
About this study
Official title: Should the Bougie be Standard Practice for Novice Intubators? A Randomized Cross-Over Study
This was a prospective, randomized cross-over manikin study in which participants first completed a standardized two-hour theoretical and hands-on training session on airway anatomy, laryngoscopy techniques, and the use of stylet and bougie. Each participant subsequently performed four intubation techniques -direct and video laryngoscopy, each combined with either a stylet or a bougie- according to a randomized sequence on the same airway manikin using a 7.5-mm endotracheal tube. The primary outcome was first-pass success, defined as successful tracheal tube placement on the first attempt. The secondary outcome was intubation time, measured from initial contact of the laryngoscope blade with the manikin to successful advancement and release of the tube; attempts exceeding five minutes were classified as failed first-pass attempts.
Read the detailed description
Airway management is a fundamental emergency medicine skill, and first-pass success in endotracheal intubation (ETI) is strongly operator-dependent. Novice intubators have lower success rates and a higher risk of complications, making the identification of simple and effective adjuncts essential in training environments. Although devices such as the bougie, stylet, and video laryngoscope are widely used, the most suitable combination for beginners remains uncertain. To address this, a controlled simulation study was conducted under standardized conditions.
This was a single-center, prospective, randomized cross-over manikin study conducted between April and July 2025 following ethics approval and written informed consent. Sixth-year medical students without prior real-world intubation experience were enrolled. Before the study procedures, all participants completed a standardized two-hour training session consisting of theoretical instruction and hands-on practice delivered in small groups by an emergency medicine specialist. Training focused on airway anatomy, laryngoscopy technique, and the correct use of both stylet and bougie, using the same airway manikin model employed in the study.
Participants were randomly assigned in a 1:1:1:1 ratio to one of four sequence groups using a computer-based online randomization tool. Each group followed a predefined order of four techniques-direct laryngoscopy with bougie (DL+B), direct laryngoscopy with stylet (DL+S), video laryngoscopy with bougie (VL+B), and video laryngoscopy with stylet (VL+S)-so that every participant performed all techniques once while minimizing order and learning effects associated with repeated attempts. Group allocation was determined before the session, and all intubations were performed according to the assigned sequence.
Intubation attempts were performed on a human airway manikin using a Macintosh size 3 blade for direct laryngoscopy and an i-view disposable video laryngoscope for video laryngoscopy. A 7.5-mm endotracheal tube was used in all attempts, and either a stylet or a bougie was applied according to the allocated technique. A 10-minute rest period was provided between attempts to reduce fatigue-related bias.
The primary outcome was first-pass success, defined as successful placement of the endotracheal tube into the trachea on the first attempt. The secondary outcome was intubation time, measured from the moment the laryngoscope blade first contacted the manikin to the moment the endotracheal tube was successfully advanced into the trachea and released, as confirmed by study observers. Attempts lasting longer than five minutes were classified as failed first-pass attempts.
- Conditions
- Endotracheal Intubation, Novice Doctor
- Being tested
- video laryngoscope+ bougie,, direct laryngoscope+ bougie, video laryngoscope+stylet, direct laryngoscope+stylet
- Keywords
- Airway management, Bougie, Stylet, novice intubator, Video laryngoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
video laryngoscope+ bougie,Other
All novice intubators performed these four intubation techniques in different sequences depending on the group allocation.
direct laryngoscope+ bougieOther
All novice intubators in Group A performed, in sequence, video laryngoscope with bougie, direct laryngoscope with bougie, video laryngoscope with stylet, and direct laryngoscope with stylet.
video laryngoscope+styletOther
All novice intubators in Group A performed, in sequence, video laryngoscope with bougie, direct laryngoscope with bougie, video laryngoscope with stylet, and direct laryngoscope with stylet.
direct laryngoscope+styletOther
All novice intubators in Group A performed, in sequence, video laryngoscope with bougie, direct laryngoscope with bougie, video laryngoscope with stylet, and direct laryngoscope with stylet.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | All novice intubators in Group A performed, in sequence, video laryngoscope with bougie, direct laryngoscope with bougie, video laryngoscope with stylet, and direct laryngoscope with stylet. Receives: Other: video laryngoscope+ bougie,; Other: direct laryngoscope+ bougie; Other: video laryngoscope+stylet; Other: direct laryngoscope+stylet |
| Group B | Active comparator | All novice intubators in Group B performed, in sequence, direct laryngoscope with bougie, video laryngoscope with bougie, direct laryngoscope with stylet, and video laryngoscope with stylet. Receives: Other: video laryngoscope+ bougie,; Other: direct laryngoscope+ bougie; Other: video laryngoscope+stylet; Other: direct laryngoscope+stylet |
| Group C | Active comparator | All novice intubators in Group C performed, in sequence, video laryngoscope with stylet, direct laryngoscope with stylet, video laryngoscope with bougie, and direct laryngoscope with bougie. Receives: Other: video laryngoscope+ bougie,; Other: direct laryngoscope+ bougie; Other: video laryngoscope+stylet; Other: direct laryngoscope+stylet |
| Group D | Active comparator | All novice intubators in Group D performed, in sequence, direct laryngoscope with stylet, video laryngoscope with stylet, direct laryngoscope with bougie, and video laryngoscope with bougie. Receives: Other: video laryngoscope+ bougie,; Other: direct laryngoscope+ bougie; Other: video laryngoscope+stylet; Other: direct laryngoscope+stylet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Firs pass success
The primary outcome of the study was first-pass success for each intubation technique. First-pass success was defined as successful placement of the endotracheal tube into the trachea on the first attempt.
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start1 May 2025
- Primary completion10 Aug 2025
- Study completion10 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endotracheal IntubationStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- randomized cross-over manikin study
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University Pendik Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emre Kudu, Marmara University Pendik Training and Research Hospital
- Investigators
- Emre Kudu, MD, Study director, Marmara University Pendik Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07422467
- Sponsor's protocol ID
- 09.2025.25-0234
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Should the Bougie be Standard Practice for Novice Intubators? A Randomized Cross-Over Study
- ClinicalTrials.gov ID
- NCT07422467
- Acronym / sponsor ID
- 09.2025.25-0234
- Conditions
- Endotracheal Intubation, Novice Doctor
- Keywords
- Airway management, Bougie, Stylet, novice intubator, Video laryngoscope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Marmara University Pendik Training and Research HospitalUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 10 Aug 2025 (actual)
- Study completion
- 10 Aug 2025 (actual)
- First posted
- 20 Feb 2026 (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.
This was a prospective, randomized cross-over manikin study in which participants first completed a standardized two-hour theoretical and hands-on training session on airway anatomy, laryngoscopy techniques, and the use of stylet and bougie. Each participant subsequently performed four intubation techniques -direct and video laryngoscopy, each combined with either a stylet or a bougie- according to a randomized sequence on the same airway manikin using a 7.5-mm endotracheal tube. The primary outcome was first-pass success, defined as successful tracheal tube placement on the first attempt. The secondary outcome was intubation time, measured from initial contact of the laryngoscope blade with the manikin to successful advancement and release of the tube; attempts exceeding five minutes were classified as failed first-pass attempts.
Detailed description
Airway management is a fundamental emergency medicine skill, and first-pass success in endotracheal intubation (ETI) is strongly operator-dependent. Novice intubators have lower success rates and a higher risk of complications, making the identification of simple and effective adjuncts essential in training environments. Although devices such as the bougie, stylet, and video laryngoscope are widely used, the most suitable combination for beginners remains uncertain. To address this, a controlled simulation study was conducted under standardized conditions.
This was a single-center, prospective, randomized cross-over manikin study conducted between April and July 2025 following ethics approval and written informed consent. Sixth-year medical students without prior real-world intubation experience were enrolled. Before the study procedures, all participants completed a standardized two-hour training session consisting of theoretical instruction and hands-on practice delivered in small groups by an emergency medicine specialist. Training focused on airway anatomy, laryngoscopy technique, and the correct use of both stylet and bougie, using the same airway manikin model employed in the study.
Participants were randomly assigned in a 1:1:1:1 ratio to one of four sequence groups using a computer-based online randomization tool. Each group followed a predefined order of four techniques-direct laryngoscopy with bougie (DL+B), direct laryngoscopy with stylet (DL+S), video laryngoscopy with bougie (VL+B), and video laryngoscopy with stylet (VL+S)-so that every participant performed all techniques once while minimizing order and learning effects associated with repeated attempts. Group allocation was determined before the session, and all intubations were performed according to the assigned sequence.
Intubation attempts were performed on a human airway manikin using a Macintosh size 3 blade for direct laryngoscopy and an i-view disposable video laryngoscope for video laryngoscopy. A 7.5-mm endotracheal tube was used in all attempts, and either a stylet or a bougie was applied according to the allocated technique. A 10-minute rest period was provided between attempts to reduce fatigue-related bias.
The primary outcome was first-pass success, defined as successful placement of the endotracheal tube into the trachea on the first attempt. The secondary outcome was intubation time, measured from the moment the laryngoscope blade first contacted the manikin to the moment the endotracheal tube was successfully advanced into the trachea and released, as confirmed by study observers. Attempts lasting longer than five minutes were classified as failed first-pass attempts.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- randomized cross-over manikin study
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Other: video laryngoscope+ bougie,, Other: direct laryngoscope+ bougie, Other: video laryngoscope+stylet, Other: direct laryngoscope+styletAll novice intubators in Group A performed, in sequence, video laryngoscope with bougie, direct laryngoscope with bougie, video laryngoscope with stylet, and direct laryngoscope with stylet. |
| Group B | Active comparator | Other: video laryngoscope+ bougie,, Other: direct laryngoscope+ bougie, Other: video laryngoscope+stylet, Other: direct laryngoscope+styletAll novice intubators in Group B performed, in sequence, direct laryngoscope with bougie, video laryngoscope with bougie, direct laryngoscope with stylet, and video laryngoscope with stylet. |
| Group C | Active comparator | Other: video laryngoscope+ bougie,, Other: direct laryngoscope+ bougie, Other: video laryngoscope+stylet, Other: direct laryngoscope+styletAll novice intubators in Group C performed, in sequence, video laryngoscope with stylet, direct laryngoscope with stylet, video laryngoscope with bougie, and direct laryngoscope with bougie. |
| Group D | Active comparator | Other: video laryngoscope+ bougie,, Other: direct laryngoscope+ bougie, Other: video laryngoscope+stylet, Other: direct laryngoscope+styletAll novice intubators in Group D performed, in sequence, direct laryngoscope with stylet, video laryngoscope with stylet, direct laryngoscope with bougie, and video laryngoscope with bougie. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Sixth-year medical students
- Not on clinical duty at the time of participation
- No scheduled clinical duty on the following day
- Free of any acute illness at the time of the study
Key exclusion criteria (1 listed)
- Any prior real-world experience in endotracheal intubation
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 |
|---|---|---|
| video laryngoscope+ bougie,All novice intubators performed these four intubation techniques in different sequences depending on the group allocation. | Other | Group A, Group B, Group C, Group D |
| direct laryngoscope+ bougieAll novice intubators in Group A performed, in sequence, video laryngoscope with bougie, direct laryngoscope with bougie, video laryngoscope with stylet, and direct laryngoscope with stylet. | Other | Group A, Group B, Group C, Group D |
| video laryngoscope+styletAll novice intubators in Group A performed, in sequence, video laryngoscope with bougie, direct laryngoscope with bougie, video laryngoscope with stylet, and direct laryngoscope with stylet. | Other | Group A, Group B, Group C, Group D |
| direct laryngoscope+styletAll novice intubators in Group A performed, in sequence, video laryngoscope with bougie, direct laryngoscope with bougie, video laryngoscope with stylet, and direct laryngoscope with stylet. | Other | Group A, Group B, Group C, Group D |
Primary outcome
Firs pass success
Time frame: During procedure
The primary outcome of the study was first-pass success for each intubation technique. First-pass success was defined as successful placement of the endotracheal tube into the trachea on the first attempt.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Emre Kudu, MD study director
Marmara University Pendik Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing video laryngoscope+ bougie,, direct laryngoscope+ bougie and video laryngoscope+stylet in people with Endotracheal Intubation and Novice Doctor, run by Marmara University Pendik Training and Research Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Firs pass success (time frame: During procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2026.