Simulation Based Medical EducationRANNCT06959953
Low-Cost Model Versus Airway Part-Task Trainer for Flexible Bronchoscope-Guided Tracheal Intubation Training
A study testing Low-cost model and Airway Part-task Trainer in people with Simulation Based Medical Education and Tracheal Intubation, run by Lebanese American University.
Trial 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. Read more about this study
- Who is it for?
- Ages 24 years and olderHealthy volunteers can take part
- Conditions the study is for
- Simulation Based Medical Education, Tracheal Intubation, Medical Residents
- What is being tested?
- Low-cost model and Airway Part-task Trainer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read more
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.
Read the 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.
- Being tested
- Low-cost model, Airway Part-task Trainer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-cost modelOther
Also called RAN LCM
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 TrainerOther
Training using Airway Part-Task Trainer
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Airway Part-task Trainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: Directly after intervention; Three months after the intervention; and Six months after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study startJan 2027 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Simulation Based Medical EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lebanese American University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rony Al Nawar, Lebanese American University Medical Center
- Investigators
- Rony Al-Nawwar, MS, Study director, Lebanese American University Medical Center - Rizk HospitalHanane Barakat, MD, Principal investigator, Lebanese American University Medical Center - Rizk Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06959953
- Sponsor's protocol ID
- LebaneseAU
- Acronym
- RAN
- Status last verified
- Oct 2026
- First submitted
- 3 Nov 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06959953
- Acronym / sponsor ID
- RAN / LebaneseAU
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Lebanese American UniversityUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 7 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-cost model (Experimental) | Experimental | Other: Low-cost modelIn 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. |
| Airway part-task trainer (Comparator) | Active comparator | Other: Airway Part-task TrainerIn 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. |
Who may qualify
- Ages
- 24 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-cost modelAlso: RAN LCMThe 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. | Other | Low-cost model (Experimental) |
| Airway Part-task TrainerTraining using Airway Part-Task Trainer | Other | Airway part-task trainer (Comparator) |
Primary outcome
A standardized global rating scale for FBTI skills assessment
Time frame: Through the completion of the study phase 1; Immediately after the Delphi rounds are completed.
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.
Knowledge assessment
Time frame: Baseline just before the Intervention; Directly after intervention; Three months after the intervention; and Six months after the intervention.
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.
Technical skills assessment
Time frame: Directly after intervention; Three months after the intervention; and Six months after the intervention.
The technical skills will be assessed using the high-fidelity CASS simulator
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rony Al-Nawwar, MS study director
Lebanese American University Medical Center - Rizk Hospital
Hanane Barakat, MD principal investigator
Lebanese American University Medical Center - Rizk Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Low-cost model and Airway Part-task Trainer in people with Simulation Based Medical Education and Tracheal Intubation, run by Lebanese American University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rony T Al Nawwar, MD (009611200800 ext. 5168, rony.alnawar@lau.edu.lb), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A standardized global rating scale for FBTI skills assessment (time frame: Through the completion of the study phase 1; Immediately after the Delphi rounds are completed.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.