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

Official title

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

Overview

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.

Detailed description

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.

Interventions

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

Primary outcome measures

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

Secondary outcome measures (4)

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

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Crossover

Masking

Single blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• University of Health Sciences, Kocaeli City Hospital — Köseköy

Identifiers

NCT: NCT07747922 · ITBP-2026-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗