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

Condition(s) studied

Investigational drug(s) / intervention(s)

EPATS (Integrated Tube-Bougie Prototype): The novel integrated tube-bougie prototype developed for endotracheal intubation.

Standard gum elastic bougie: Standard gum elastic bougie used as an intubation adjunct.

Standard stylet: Standard intubating stylet used as an intubation adjunct.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Time to successful endotracheal intubation — During the study procedure
  The insertion and removal time (seconds) of the laryngoscope from the mouth will be recorded.

Trial sites (1)

Other trials for the same condition