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

NCT06959953 | Not Yet Recruiting DMC

• 1 other identifier: LebaneseAU
• Study Type: interventional
• Target: 53
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Simulation Based Medical Education; Tracheal Intubation; Medical Residents

Outcome Measures

Primary Outcomes (3)

• 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.

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

• 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.

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

• Technical skills assessment

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

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

Study Arms (2)

Low-cost model (Experimental)

EXPERIMENTAL

In this arm, the residents will train using the locally designed low-cost model that was developed by the study investigator at his institution. Here is a short description of the developed model: RAN is a low-cost, locally designed model developed at the investigator's institution using readily available and recyclable materials. This model provides a simulation environment for anesthesiology residents to practice and refine their skills. The primary structure of the training model is fashioned from an old portable 3-drawer organizer unit, repurposed to serve as the foundation for the training apparatus. Utilizing recyclable anesthesia items, including endotracheal tubes (both single lumen and double lumen) with their cuffs, connectors, laryngeal mask airways, oropharyngeal and nasopharyngeal airways, the model replicates the anatomy and equipment encountered during tracheal intubation procedures.

Other: Low-cost model

Airway part-task trainer (Comparator)

ACTIVE COMPARATOR

In this group, the participants will undergo hands-on training using the commercial airway part-task trainer. The commercial airway part-task trainer is the routinely used simulator at the investigator's institution and other institutions as well.

Other: Airway Part-task Trainer

Interventions

Low-cost model OTHER

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.

Also known as: RAN LCM

Low-cost model (Experimental)

Airway Part-task Trainer OTHER

Training using Airway Part-Task Trainer

Airway part-task trainer (Comparator)

Eligibility Criteria

• Age: 24 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Lebanese American University: lead

Study Officials

• Rony Al-Nawwar, MS

  Lebanese American University Medical Center - Rizk Hospital

  STUDY DIRECTOR

• Hanane Barakat, MD

  Lebanese American University Medical Center - Rizk Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rony T Al Nawwar, MD

CONTACT

009611200800; rony.alnawar@lau.edu.lb

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor and the data analyst will be blinded for the allocation arm.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor in Anesthesiology

Study Record Dates

• First Submitted: November 3, 2024
• First Posted: May 7, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share