Airway ManagementNCT07681453
Blind Intubation Through the Tulip Airway Versus Direct Laryngoscopy
A study testing Tulip oropharyngeal airway and Direct laryngoscopy in people with Airway Management, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Airway Management
- What is being tested?
- Tulip oropharyngeal airway and Direct laryngoscopy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jul 2026to 7 Aug 2026
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Etlik City Hospital, Ministry of Health, Türkiye
Ankara, 06170
About this study
Official title: 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.
Read the 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.
- Conditions
- Airway Management
- Being tested
- Tulip oropharyngeal airway, Direct laryngoscopy
- Keywords
- Airway management, endotracheal intubation, Tulip airway, direct laryngoscopy, simulation study, crossover trial, anesthesia education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tulip oropharyngeal airwayDevice
Endotracheal intubation via Tulip airway in a simulated mannequin setting.
Direct laryngoscopyProcedure or surgery
Standard endotracheal intubation using direct laryngoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Tulip Airway | Active comparator | Blind endotracheal intubation via Tulip oropharyngeal airway in a simulated mannequin environment. Receives: Device: Tulip oropharyngeal airway |
| Direct Laryngoscopy | Active comparator | Endotracheal intubation using standard direct laryngoscopy in a simulated mannequin environment. Receives: Procedure: Direct laryngoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At each endotracheal intubation attempt during the single-day randomized crossover simulation session in a mannequin model
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start6 Jul 2026
- Primary completion7 Aug 2026
- Study completion7 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ManagementStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Fethi Gültop, Ankara Etlik City Hospital
- Investigators
- Fethi Gültop, MD, Principal investigator, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07681453
- Sponsor's protocol ID
- tulip-2026
- Status last verified
- Aug 2026
- First submitted
- 23 Jun 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a simulation-based study using mannequin models; therefore, individual participant-level clinical data are not applicable and will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Blind Endotracheal Intubation Through the Tulip Oropharyngeal Airway and Direct Laryngoscopy by Novice Operators: A Randomized Crossover Manikin Study
- ClinicalTrials.gov ID
- NCT07681453
- Acronym / sponsor ID
- tulip-2026
- Conditions
- Airway Management
- Keywords
- Airway management, endotracheal intubation, Tulip airway, direct laryngoscopy, simulation study, crossover trial, anesthesia education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 6 Jul 2026 (actual)
- Primary completion
- 7 Aug 2026 (actual)
- Study completion
- 7 Aug 2026 (actual)
- First posted
- 2 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Tulip Airway | Active comparator | Device: Tulip oropharyngeal airwayBlind endotracheal intubation via Tulip oropharyngeal airway in a simulated mannequin environment. |
| Direct Laryngoscopy | Active comparator | Procedure: Direct laryngoscopyEndotracheal intubation using standard direct laryngoscopy in a simulated mannequin environment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tulip oropharyngeal airwayEndotracheal intubation via Tulip airway in a simulated mannequin setting. | Device | Tulip Airway |
| Direct laryngoscopyStandard endotracheal intubation using direct laryngoscopy. | Procedure or surgery | Direct Laryngoscopy |
Primary outcome
First-pass intubation success rate
Time frame: At each endotracheal intubation attempt during the single-day randomized crossover simulation session in a mannequin model
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No. This is a simulation-based study using mannequin models; therefore, individual participant-level clinical data are not applicable and will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fethi Gültop, MD principal investigator
Ankara Etlik City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tulip oropharyngeal airway and Direct laryngoscopy in people with Airway Management, run by Ankara Etlik City 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 3 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 Aug 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?
First-pass intubation success rate (time frame: At each endotracheal intubation attempt during the single-day randomized crossover simulation session in a mannequin model). 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 Aug 2026.