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

NCT07747922 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-08-05

No results posted yet for this 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.

Conditions

  • Airway Management
  • Endotracheal Intubation
  • Difficult Airway

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.

Sponsors & Collaborators

  • Health Institutes of Turkey

    collaborator OTHER_GOV

  • Huseyin Cahit Halhalli, MD

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-08-10
Primary Completion
2026-08-24
Completion
2026-08-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07747922 on ClinicalTrials.gov