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

Официальное название

A Prospective Randomized Crossover Simulation Study Comparing an Integrated Tube-Bougie Prototype With Standard Stilet-Assisted and Gum Elastic Bougie Assisted Endotracheal Intubation

Обзор

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.

Подробное описание

Endotracheal intubation is one of the most commonly performed advanced airway procedures in emergency and critical care. Successful intubation depends not only on adequate visualization of the glottis but also on successful advancement of the endotracheal tube through the vocal cords. Adjunctive devices, such as stylets and elastic bougies, are widely used to facilitate tube placement. However, these devices require additional procedural steps and device exchanges, which may increase procedural complexity and prolong intubation time.

EPATS (Integrated Tube-Bougie Prototype) is a novel airway device developed to integrate the guidance function of an elastic bougie directly into an endotracheal tube. By combining both functions into a single device, EPATS is intended to simplify the intubation process while preserving the advantages of bougie-assisted intubation.

This prospective, randomized, crossover simulation study will evaluate the performance of EPATS compared with conventional elastic bougie-assisted and stylet-assisted endotracheal intubation. Emergency medicine residents will perform endotracheal intubation using all three techniques in both normal and difficult airway simulation scenarios according to a randomized crossover sequence. Before study initiation, all participants will receive standardized training in the use of EPATS and the elastic bougie appropriate to their level of experience. All intubation procedures will be performed under standardized simulation conditions.

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.

This study will determine whether EPATS improves procedural efficiency and intubation performance compared with conventional intubation adjuncts in a standardized simulation environment.

Вмешательства

• Устройство EPATS (Integrated Tube-Bougie Prototype)
  The novel integrated tube-bougie prototype developed for endotracheal intubation.
• Устройство Standard gum elastic bougie
  Standard gum elastic bougie used as an intubation adjunct.
• Устройство Standard stylet
  Standard intubating stylet used as an intubation adjunct.

Первичные конечные точки

• Time to successful endotracheal intubation [Срок оценки: During the study procedure]

Вторичные конечные точки (4)

• First Pass Success (FPS) [Срок оценки: During the study procedure]
• Difficulty Assessment (VAS) [Срок оценки: At the end of the study procedure]
• Complications (Dental trauma and Esophageal intubation) [Срок оценки: During the study procedure]
• Learning Curve (CUSUM) [Срок оценки: During the study procedure]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• University of Health Sciences, Kocaeli City Hospital — Köseköy

Идентификаторы

NCT: NCT07747922 · ITBP-2026-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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