NCT07422467

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 20, 2026

Completed
Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

February 10, 2026

Last Update Submit

February 19, 2026

Conditions

Keywords

Airway managementBougieStyletnovice intubatorVideo laryngoscope

Outcome Measures

Primary Outcomes (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.

    During procedure

Study Arms (4)

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.

Other: video laryngoscope+ bougie,Other: direct laryngoscope+ bougieOther: video laryngoscope+styletOther: 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.

Other: video laryngoscope+ bougie,Other: direct laryngoscope+ bougieOther: video laryngoscope+styletOther: 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.

Other: video laryngoscope+ bougie,Other: direct laryngoscope+ bougieOther: video laryngoscope+styletOther: 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.

Other: video laryngoscope+ bougie,Other: direct laryngoscope+ bougieOther: video laryngoscope+styletOther: direct laryngoscope+stylet

Interventions

All novice intubators performed these four intubation techniques in different sequences depending on the group allocation.

Group AGroup BGroup CGroup D

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.

Group AGroup BGroup CGroup D

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.

Group AGroup BGroup CGroup D

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.

Group AGroup BGroup CGroup D

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Any prior real-world experience in endotracheal intubation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University Pendik Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Study Officials

  • Emre Kudu, MD

    Marmara University Pendik Training and Research Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: randomized cross-over manikin study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 10, 2026

First Posted

February 20, 2026

Study Start

May 1, 2025

Primary Completion

August 10, 2025

Study Completion

August 10, 2025

Last Updated

February 20, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations