NCT07681453

Brief Summary

This is a randomized crossover mannequin study comparing two airway management techniques in novice operators: blind endotracheal intubation via the Tulip oropharyngeal airway versus direct laryngoscopy. The study aims to evaluate and compare the success rate and performance characteristics of both methods under simulated conditions in order to assess their effectiveness in airway management training and practice.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
0mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress75%
Jul 2026Aug 2026

First Submitted

Initial submission to the registry

June 23, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 2, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

July 6, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2026

Last Updated

July 13, 2026

Status Verified

July 1, 2026

Enrollment Period

1 month

First QC Date

June 23, 2026

Last Update Submit

July 10, 2026

Conditions

Keywords

Airway managementendotracheal intubationTulip airwaydirect laryngoscopysimulation studycrossover trialanesthesia education

Outcome Measures

Primary Outcomes (1)

  • First-pass intubation success rate

    Comparison of first-attempt success rate of endotracheal intubation using Tulip oropharyngeal airway versus direct laryngoscopy in a simulated mannequin setting performed by novice operators in a randomized crossover design.

    At each endotracheal intubation attempt during the single-day randomized crossover simulation session in a mannequin model

Study Arms (2)

Tulip Airway

ACTIVE COMPARATOR

Blind endotracheal intubation via Tulip oropharyngeal airway in a simulated mannequin environment.

Device: Tulip oropharyngeal airway

Direct Laryngoscopy

ACTIVE COMPARATOR

Endotracheal intubation using standard direct laryngoscopy in a simulated mannequin environment.

Procedure: Direct laryngoscopy

Interventions

Endotracheal intubation via Tulip airway in a simulated mannequin setting.

Tulip Airway

Standard endotracheal intubation using direct laryngoscopy.

Direct Laryngoscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Voluntary participation in the study
  • Anesthesia technician students with no prior airway management experience
  • Age ≥ 18 years
  • Willingness to participate in simulation-based intubation procedures

You may not qualify if:

  • Prior advanced airway management experience (e.g., regular intubation practice in clinical settings)
  • Refusal to participate or withdraw consent
  • Inability to complete simulation procedures for any reason

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Etlik City Hospital, Ministry of Health, Türkiye

Ankara, 06170, Turkey (Türkiye)

RECRUITING

Study Officials

  • Fethi Gültop, MD

    Ankara Etlik City Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fethi Gültop, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No masking is used in this study. Both participants and investigators are aware of the intervention being performed, and outcome assessment is conducted in an open-label manner during a simulation-based setting.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: This is a randomized crossover simulation study in which each participant performs endotracheal intubation using two different airway management techniques: blind intubation via the Tulip oropharyngeal airway and direct laryngoscopy. The order of interventions is randomized, and each participant serves as their own control. All procedures are conducted on airway mannequins in a controlled simulation environment, allowing direct comparison of the two techniques under standardized conditions.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 23, 2026

First Posted

July 2, 2026

Study Start

July 6, 2026

Primary Completion (Estimated)

August 10, 2026

Study Completion (Estimated)

August 10, 2026

Last Updated

July 13, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

This is a simulation-based study using mannequin models; therefore, individual participant-level clinical data are not applicable and will not be shared.

Locations