Novel Integrated Tube-Bougie Prototype for Endotracheal Intubation in Airway Simulation

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Conditions studied: Airway Management, Endotracheal Intubation, Difficult Airway

In brief

Endotracheal intubation is a critical airway management procedure that frequently requires adjunctive devices, such as stylets or elastic bougies, to facilitate successful tube placement. Although videolaryngoscopy has become increasingly common, access to videolaryngoscopes remains limited in certain clinical settings, particularly in prehospital and resource-constrained environments. Consequently, stylets and bougies continue to play an essential role in airway management. To address this need, we developed a novel integrated tube-bougie prototype that combines the guidance function of an elastic bougie with an endotracheal tube into a single device. This prospective, randomized, crossover simulation study is designed to compare the performance of the integrated tube-bougie prototype with conventional stylet-assisted and elastic bougie-assisted endotracheal intubation. Emergency medicine residents will perform intubations using all three techniques in both normal and difficult airway simulation scenarios according to a randomized crossover sequence. The primary outcome is the time to successful endotracheal intubation. Secondary outcomes include first-attempt intubation success, perceived procedural difficulty assessed using a visual analog scale (VAS), incidence of esophageal intubation, dental trauma, and evaluation of the learning curve using cumulative sum (CUSUM) analysis. The findings could contribute to the development of alternative airway assistive equipment for emergency airway management and training.

Key facts

Study ID

NCT07747922

Run by

Huseyin Cahit Halhalli, MD

People needed

40

Starts

2026-08-10

Expected to finish

2026-08-30

Last updated by the study team

2026-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Professional Status: Being an Emergency Medicine Resident actively undergoing specialty training at the University of Health Sciences, Kocaeli City Hospital, Department of Emergency Medicine.
• Voluntary Participation: Voluntarily agreeing to participate in the study and providing written informed consent prior to enrollment.
• Postgraduate year (PGY) 1-4 residents.
• Willing and able to provide written informed consent.

You may not qualify if…

• Refusal to Participate: Declining to participate or refusing to provide written informed consent.
• Physical or Neurological Limitations: Having any pre-existing physical, motor, or neurological impairment that could interfere with manual dexterity, procedural performance, or airway management simulation (e.g., hand injuries, tremors, etc.).
• Inability to complete all study procedures.

Where it is running

• University of Health Sciences, Kocaeli City Hospital — Köseköy, Kocaeli, Turkey (Türkiye)

Full record on ClinicalTrials.gov

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