Blind Intubation Through the Tulip Airway Versus Direct L... | NCT07681453

Studies
Blind Intubation Through the Tulip Airway Versus Direct Laryngoscopy

NCT07681453

Sponsor

Ankara Etlik City Hospital

Status

Not yet recruiting

Last Update Posted

Jul 7, 2026Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Airway Management

Interventions

Tulip oropharyngeal airway
Direct laryngoscopy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 10, 2026Estimated

Primary Completion Date

Aug 10, 2026Estimated

Completion Date

Aug 10, 2026Estimated

First Submitted Date

Jun 23, 2026

First Submission Date that Met QC Criteria

Jun 26, 2026

First Posted Date

Jul 2, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 3, 2026

Last Update Posted Date

Jul 7, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Fethi Gültop, Principal Investigator, Ankara Etlik City HospitalPrincipal Investigator

Lead Sponsor

Ankara Etlik City HospitalOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

This study is a randomized crossover mannequin-based simulation designed to compare two endotracheal intubation techniques performed by novice operators with limited or no prior intubation experience.

Participants will perform tracheal intubation using two different methods in a randomized order: (1) blind endotracheal intubation via the Tulip oropharyngeal airway, and (2) direct laryngoscopy. Each participant will serve as their own control in a crossover design, allowing direct comparison of the two techniques under standardized simulated airway conditions.

The primary objective is to compare the success rate of intubation between the two techniques. Secondary outcomes may include time to successful intubation, number of attempts, and ease of use, as assessed in a controlled simulation environment.

All procedures will be performed on airway mannequins in a simulation setting without involving human subjects or patient care. The study is intended to evaluate technical performance and feasibility in a standardized training environment, rather than clinical effectiveness in patients.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Tulip oropharyngeal airway	Device	Endotracheal intubation via Tulip airway in a simulated mannequin setting.	Tulip Airway

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Fethi Gültop, MD	Contact	+90 505 2260067		fethigultop@yahoo.com

Overall Officials

Name	Affiliation	Role
Fethi Gültop, MD	Ankara Etlik City Hospital	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Model Description

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.

Masking Info

Masking

None (Open Label)

Masking Description

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.

Who Masked

Not provided