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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Turkey (Türkiye)

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.

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 groups in NCT07422467
Study groupRoleWhat they receive
Group AActive comparatorAll 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 BActive comparatorAll 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 CActive comparatorAll 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 DActive comparatorAll 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.

  1. 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.

  1. First posted20 Feb 2026
  2. Study start1 May 2025
  3. Primary completion10 Aug 2025
  4. Study completion10 Aug 2025

Resources

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)
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

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.

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