What is this study trying to find out about bronchoscopy training?

This study evaluates whether training using multiple patient-specific CT-derived digital twin airway models can improve the early learning curve of novice bronchoscopists compared to traditional simulation training with uniform airway models. Researchers aim to understand how anatomical variability training affects skill development during initial clinical procedures.

Who may be eligible for this bronchoscopy clinical trial?

Adults aged 18 to 75 who are residents, fellows, or specialty trainees in relevant medical fields with five or fewer prior flexible bronchoscopies and no prior formal simulation training may be eligible. Participants must provide informed consent and be willing to participate in all study procedures. Please review eligibility criteria for more details.

Is there any cost to participate in this bronchoscopy clinical trial?

Study-related care, including the simulation training and clinical evaluations, is provided at no cost. However, participants may have personal travel expenses that are not guaranteed to be covered. Planning for these expenses is recommended.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 75Years

All Genders

ID07718451

Study Comparing Multi-Patient CT-Derived Digital Twin Anatomical Variability Training Versus Uniform Simulation Models to Improve Early Bronchoscopy Skills in Novice Trainees

Led by Gang Hou · Updated on 2026-07-22

110

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating whether multi-patient CT-derived digital twin anatomical variability training can shorten the early clinical learning curve for novice bronchoscopists compared with conventional anatomically uniform bronchoscopy simulation training. The study focuses on trainees in pulmonary medicine, critical care, thoracic surgery, anesthesiology, or related fields who have performed five or fewer flexible bronchoscopies and have no prior formal bronchoscopy simulation training. The main goal is to assess improvements in clinical bronchoscopy performance using the Ontario Bronchoscopy Assessment Tool OBAT during the first 1 to 30 supervised real-patient flexible bronchoscopies. Participants will be randomly assigned to one of two training groups one using multiple patient-specific CT-derived digital twin airway models representing diverse bronchial anatomical variations, and the other using a conventional anatomically uniform standard airway model. Both groups receive equal training duration, instructor supervision, and standardized feedback. After training, participants will perform simulation transfer tests on previously unseen airway models and then conduct supervised real-patient low-risk diagnostic flexible bronchoscopies during their clinical training. Throughout the study, participants competence will be monitored through repeated assessments with the OBAT, procedural efficiency metrics, and safety evaluations. Real patients will complete questionnaires about anxiety, discomfort, coughing, satisfaction, and willingness to repeat bronchoscopy. The study tracks early clinical bronchoscopy performance up to 12 weeks after randomization and extended learning-curve performance up to 18 months, with data collection including training logs, procedural videos, and clinical outcomes.

CONDITIONS

Brief Title

Randomized Controlled Trial of Multi-Patient CT-Derived Digital Twin Anatomical Variability Training to Shorten the Clinical Learning Curve for Bronchoscopy

Who Can Participate

Age: 18Years - 75Years

All Genders

Eligibility Criteria

You may qualify if you...

Residents, fellows, or specialty trainees in pulmonary medicine, critical care medicine, thoracic surgery, anesthesiology, or related fields requiring flexible bronchoscopy training
Performed 5 or fewer flexible bronchoscopies as the primary operator
No prior formal bronchoscopy simulation training course experience
Able and willing to provide written informed consent and allow use of training logs, videos, and assessment data
Patients aged 18 years or older scheduled for elective low-risk or low-to-moderate-risk diagnostic flexible bronchoscopy
Patients clinically suitable for supervised novice-performed low-risk airway inspection or sampling procedures
Patients able to understand and provide written informed consent and willing to complete procedure-related questionnaires

You will not qualify if you...

Trainees who have performed more than 5 flexible bronchoscopies or completed structured bronchoscopy simulation training
Trainees planning to leave their training program during the study or unable to complete follow-up through at least 30 clinical cases
Trainees unable to participate in simulation training or unwilling to allow procedural video recording
Trainees with significant additional bronchoscopy training outside the study protocol (documented and analyzed separately)
Patients requiring emergency bronchoscopy, intubated ICU patients, or those with severe hypoxemia or hemodynamic instability
Patients undergoing therapeutic bronchoscopy, complex central airway stenosis, high bleeding risk, or advanced interventional procedures unsuitable for novices
Patients having complex sampling procedures such as EBUS-TBNA, transbronchial lung biopsy, or cryobiopsy excluded from primary endpoint analysis
Patients refusing trainee participation or procedural recording and/or questionnaire completion

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Simulation Training

Duration - Duration as per training schedule prior to clinical procedures

Participants receive bronchoscopy simulation training using either multiple patient-specific CT-derived airway models or a uniform standard airway model, with standardized instructor feedback and practice.

Training sessions with instructor supervision

Supervised Clinical Bronchoscopy

Duration - Up to 12 weeks after randomization for first 30 procedures; extended monitoring up to 18 months for procedures 31-50

Participants perform supervised real-patient flexible bronchoscopies during clinical training, with repeated competency assessments and safety monitoring.

Supervised clinical procedures and assessments