Airway Management
Conditions
Keywords
Airway management, endotracheal intubation, Tulip airway, direct laryngoscopy, simulation study, crossover trial, anesthesia education
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.
Interventions
DEVICETulip oropharyngeal airway
Endotracheal intubation via Tulip airway in a simulated mannequin setting.
PROCEDUREDirect laryngoscopy
Standard endotracheal intubation using direct laryngoscopy.
Sponsors
Ankara Etlik City Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
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.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First-pass intubation success rate | 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. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORFethi Gültop, MD
Ankara Etlik City Hospital
Outcome results
None listed