Low-Cost Model Versus Airway Part-Task Trainer for Flexible Bronchoscope-Guided Tracheal Intubation Training

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age24+
SponsorLebanese American University

About this trial

Background: Awake flexible bronchoscope-guided tracheal intubation (FBTI) is crucial in managing challenging airway situations. As the gold standard for difficult airway management, FBTI is essential for anesthesiologists to navigate anatomical complexities effectively.

Training in FBTI requires theoretical understanding, hands-on practice, and experience. Skill acquisition and knowledge must reach an appropriate level before trainees perform on patients. Simulated scenarios offer a controlled environment for practitioners to develop muscle memory and problem-solving skills without risking patient safety. However, commercial simulators for FBTI are often expensive and inaccessible in many countries. Lebanon, a low- and middle-income country, currently faces a multifaceted economic and financial crisis. Hence, securing enough internal funds to support novice learners using available high-cost simulator training is challenging. Various low-cost simulators have been proposed in the literature, aiming to provide affordable training for novice anesthesiologists, particularly in regions where expensive simulators are scarce.

Aim: This study aims to evaluate a low-cost, locally designed simulator by comparing skill acquisition and retention to a commercial airway part-task trainer in FBTI.

Study design: Multicenter simulation-based randomized controlled trial (RCT) Methods: This simulation-based interventional clinical trial will include anesthesia PGY-I and PGY-II residents inexperienced in FBTI techniques from eight medical schools in Lebanon. The study comprises two main phases and one intermediate phase. Phase one is the development phase, whereby a Delphi approach will be utilized to develop a standardized Global Rating Scale for FBTI (LAU-modified SGR). The intermediate phase constitutes piloting the tool developed with LAU postgraduate trainees years 3, 4, and 5 from the pulmonology department, Ear, Nose, and Throat department, along with the anesthesiology residents. Phase two is the main RCT study whereby all participating residents will receive training on a theoretical course covering flexible bronchoscopy equipment, anatomy, indications, and complications, which will also be supplemented by a procedural video. After which residents will be randomly assigned to one of two groups. One group will undergo training on the locally designed low-cost model (RAN), whereas the other group will train on the airway part-task trainer. Participants' FBTI skills will be assessed using the high-fidelity CAS simulator and the LAU-modified SGR for FBTI to evaluate both theoretical and procedural fluency (i.e., retention of FBTI skills). Assessments will be conducted immediately after the training sessions, with follow-ups at three and six months.

Significance: The utilization of low-cost simulators enables the integration of simulation training for healthcare professionals across diverse settings, facilitating skill transfer to clinical practice effectively at the lowest cost possible.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Low-cost model

    Other intervention

    The primary structure of a low-cost training model fashioned from an old portable 3-drawer organizer unit repurposed to serve as the foundation for the training apparatus. This training apparatus will act as the experimental arm to compare it to the Airway Part-Task Trainer in FBTI.

  • Airway Part-task Trainer

    Other intervention

    Training using Airway Part-Task Trainer

Treatment groups

53 Participants
are divided into 2 treatment groups
Group A: Low-cost model (Experimental)Experimental treatment 1 intervention
Group B: Airway part-task trainer (Comparator)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

A standardized global rating scale for FBTI skills assessment

The standardized global rating scale for FBTI skills assessment will be an adapted version of an existing global rating scale. It will be refined through Delphi rounds to achieve consensus in the first phase of this study.

Time frame
Through the completion of the study phase 1; Immediately after the Delphi rounds are completed.
2

Knowledge assessment

Total score on the global rating scale (which will be the final output of the study phase 1: Delphi to improve and revise an available global rating scale). The higher the score on each item assessed the better the knowledge retained/acquired by the resident.

Time frame
Baseline just before the Intervention; Directly after intervention; Three months after the intervention; and Six months after the intervention.
3

Technical skills assessment

The technical skills will be assessed using the high-fidelity CASS simulator

Time frame
Directly after intervention; Three months after the intervention; and Six months after the intervention.

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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Lebanese American University

Lead sponsor

Lebanese American University Medical Center

Sponsor institution

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