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

ConditionsAirway ManagementEndotracheal IntubationDifficult Airway
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHuseyin Cahit Halhalli, MD

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 3 treatment groups
Group A: EPATSExperimental treatment 1 intervention
Group B: Standard Gum Elastic BougieActive comparator 1 intervention
Group C: Standard StyletActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Time to successful endotracheal intubation

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

Time frame
During the study procedure

Secondary outcomes

1

First Pass Success (FPS)

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

Time frame
During the study procedure
2

Difficulty Assessment (VAS)

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

Time frame
At the end of the study procedure
3

Complications (Dental trauma and Esophageal intubation)

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

Time frame
During the study procedure
4

Learning Curve (CUSUM)

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.

Time frame
During the study procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Huseyin Cahit Halhalli, MD

Lead sponsor

Kocaeli City Hospital

Sponsor institution

Health Institutes of Turkey

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: