Blind Intubation Through the Tulip Airway Versus Direct Laryngoscopy

Comparison of Blind Endotracheal Intubation Through the Tulip Oropharyngeal Airway and Direct Laryngoscopy by Novice Operators: A Randomized Crossover Manikin Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Airway Management
• Intervention / Treatment: Device: Tulip oropharyngeal airway; Procedure: Direct laryngoscopy

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fethi Gültop, MD; Phone Number: +90 505 2260067; Email: fethigultop@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tulip Airway; Blind endotracheal intubation via Tulip oropharyngeal airway in a simulated mannequin environment.	Device: Tulip oropharyngeal airway; Endotracheal intubation via Tulip airway in a simulated mannequin setting.
Active Comparator: Direct Laryngoscopy; Endotracheal intubation using standard direct laryngoscopy in a simulated mannequin environment.	Procedure: Direct laryngoscopy; Standard endotracheal intubation using direct laryngoscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
• Investigators: Principal Investigator: Fethi Gültop, MD, Ankara Etlik City Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 10, 2026
• Primary Completion (Estimated): August 10, 2026
• Study Completion (Estimated): August 10, 2026

Study Registration Dates

• First Submitted: June 23, 2026
• First Submitted That Met QC Criteria: June 26, 2026
• First Posted (Actual): July 2, 2026

Study Record Updates

• Last Update Posted (Actual): July 2, 2026
• Last Update Submitted That Met QC Criteria: June 26, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: endotracheal intubation; Airway management; direct laryngoscopy; simulation study; crossover trial; Tulip airway; anesthesia education
• Other Study ID Numbers: tulip-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a simulation-based study using mannequin models; therefore, individual participant-level clinical data are not applicable and will not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No