Clinical trial NCT06959953: Low-Cost Model Versus Airway Part-Task Trainer for Flexible Bronchoscope-Guided Tracheal Intubation Training
Official title: Low-cost Model Versus Airway Part-task Trainer for Flexible Bronchoscope-guided Tracheal Intubation Training: A Multicenter, Non-inferiority, Simulation-based Trial Among Anesthesiology Residents in Lebanon
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Simulation Based Medical Education
Tracheal Intubation
Medical Residents
Lead sponsor: Lebanese American University
Sponsor class: OTHER
First posted: 2025-05-07
Enrollment: 53
Sex: ALL
Minimum age (years): 24
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed description: This study evaluates the effectiveness of a low-cost, locally designed simulation model (RAN) for flexible bronchoscope-guided tracheal intubation (FBTI) training, compared to a commercial airway part-task trainer. It aims to assess residents' skill acquisition, retention, and proficiency, promoting affordable simulation-based training.

The study follows a three-phase design:

Delphi Phase: Experts develop a standardized Global Rating Scale (GRS) for assessing FBTI skills through consensus.

Intermediate Phase: Piloting the tool with advanced trainees to ensure reliability and validity.

Main RCT Phase: PGY 1 and 2 residents, with no prior FBTI experience, are recruited from eight medical centers in Lebanon. Participants are randomly assigned to either the experimental (RAN model) or control (commercial trainer) group. Their FBTI skills are evaluated after training, and again at 3- and 6-month follow-ups, using the GRS on a high-fidelity airway simulator.

Data collection focuses on skill performance, with statistical models analyzing changes over time and between groups. The study aims to improve training accessibility while maintaining educational effectiveness.

Eligibility criteria: Phase 1: Expert committee Intermediate phase: Postgraduate fellows and residents from pulmonology and ENT, along with senior anesthesia residents Phase 2: Inclusion criteria include PGY 1 and 2 levels with no previous experience with FBTI and belonging to one of the eight prespecified medical centers. Any resident with prior exposure and experience with FBTI will be excluded.

Primary outcomes:
measure: A standardized global rating scale for FBTI skills assessment
timeFrame: Through the completion of the study phase 1; Immediately after the Delphi rounds are completed.
measure: Knowledge assessment
timeFrame: Baseline just before the Intervention; Directly after intervention; Three months after the intervention; and Six months after the intervention.
measure: Technical skills assessment
timeFrame: Directly after intervention; Three months after the intervention; and Six months after the intervention.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Lebanese American University Medical Center - Rizk Hospital
name: Rony Al-Nawwar, MS
role: STUDY_DIRECTOR
affiliation: Lebanese American University Medical Center - Rizk Hospital
name: Hanane Barakat, MD
role: PRINCIPAL_INVESTIGATOR
References: