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NCT Number: NCT07747922

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Health Sciences, Kocaeli City Hospital

Köseköy, Kocaeli, 41060, Turkey (Türkiye)

Location contact

Huseyin Cahit Halhalli, MD

CONTACT

[email protected]

+902622252700

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EPATS (Integrated Tube-Bougie Prototype)

Device

The novel integrated tube-bougie prototype developed for endotracheal intubation.

Standard gum elastic bougie

Device

Standard gum elastic bougie used as an intubation adjunct.

Standard stylet

Device

Standard intubating stylet used as an intubation adjunct.

Primary outcomes

  1. Time to successful endotracheal intubation

    Time frame: During the study procedure

    The insertion and removal time (seconds) of the laryngoscope from the mouth will be recorded.

Secondary outcomes

  1. First Pass Success (FPS)

    Time frame: During the study procedure

    Successful endotracheal intubation without removing the laryngoscope from the mouth. Attempts exceeding 60 seconds will be considered unsuccessful.

  2. Difficulty Assessment (VAS)

    Time frame: At the end of the study procedure

    The practitioner's difficulty perception will be measured using a 0-100 mm visual analog scale.

  3. Complications (Dental trauma and Esophageal intubation)

    Time frame: During the study procedure

    Complications for each procedure (dental trauma and esophageal intubation) will be determined by the researchers.

  4. Learning Curve (CUSUM)

    Time frame: During the study procedure

    For each participant, success/failure data will be used for analysis; this analysis will be considered exploratory. The number of endotracheal intubation attempts required to learn will be recorded in the data collection. Sequential intubation performance data will be analyzed using cumulative sum (CUSUM) analysis.

Study contacts

Contact information is provided by the study sponsor or research team.

Huseyin Cahit Halhalli, MD

CONTACT

[email protected]

+902622252700

Sponsors and collaborators

Lead sponsor

Huseyin Cahit Halhalli, MD

Other Gov

Collaborators

  • Health Institutes of Turkey

Registry information

Official study title

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

Acronym: ITBP

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 5, 2026
Registry last updated
Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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