Recruiting
Not applicable
Randomized Controlled Trial of Multi-Patient CT-Derived Digital Twin Anatomical Variability Training to Shorten the Clinical Learning Curve for Bronchoscopy
Condition(s) studied
BronchoscopyLearning Curves and Outcomes of Simulation-based TrainingLearning Curve
Investigational drug(s) / intervention(s)
Multi-patient CT-derived digital twin anatomical variability trainingAnatomically uniform standard-model bronchoscopy simulation training
Multi-patient CT-derived digital twin anatomical variability training: Participants assigned to this intervention receive bronchoscopy simulation training using multiple patient-specific CT-derived digital twin airway models representing diverse bronchial anatomical patterns and variations. The training is designed to expose novice bronchoscopists to realistic inter-patient anatomical variability, with standardized instructor feedback, repeated navigation practice, and progressive procedural tasks aimed at improving adaptability, airway recognition, navigation efficiency, and early clinical bronchoscopy performance.
Anatomically uniform standard-model bronchoscopy simulation training: Participants assigned to the control intervention receive bronchoscopy simulation training using a conventional anatomically uniform standard airway model without substantial anatomical variation between cases. Training duration, instructor supervision, and procedural objectives are standardized to match the intervention group, focusing on basic bronchoscopy handling, airway navigation, and procedural technique within a fixed and repetitive anatomical environment
Study summary
This study aims to determine whether multi-patient CT-derived digital twin anatomical variability training can shorten the early clinical learning curve of novice bronchoscopists compared with conventional anatomically uniform bronchoscopy simulation training.
Eligibility
Inclusion Criteria:
Trainee Participants:
1. Residents, fellows, or specialty trainees in pulmonary medicine, critical care medicine, thoracic surgery, anesthesiology, or related specialties whose training programs require flexible bronchoscopy training.
2. Previously performed ≤5 flexible bronchoscopies as primary operator.
3. No prior formal bronchoscopy simulation training course experience.
4. Able and willing to provide written informed consent and permit use of training logs, procedural videos, Ontario Bronchoscopy Assessment Tool (OBAT) scores, and clinical learning curve data for research purposes.
Patient Participants:
1. Age ≥18 years.
2. Scheduled to undergo elective low-risk or low-to-moderate-risk diagnostic flexible bronchoscopy.
3. Clinically suitable for supervised novice-performed airway inspection, bronchoalveolar lavage, simple brushing, or other low-risk sampling procedures considered safe by the supervising bronchoscopist.
4. Able to understand and provide written informed consent and willing to complete pre-procedure anxiety and post-procedure experience questionnaires.
Exclusion Criteria:
Trainee Participants:
1. Previously performed \>5 flexible bronchoscopies or previously completed a structured bronchoscopy simulation training program.
2. Planned departure from the training program during the study period or anticipated inability to complete follow-up through at least clinical cases 1-30.
3. Unable to participate in simulation training or unwilling to permit procedural video recording.
4. Significant additional bronchoscopy training exposure outside the study protocol; such cases may not necessarily be excluded but will be documented and addressed in sensitivity analyses.
Patient Participants:
1. Emergency bronchoscopy, intubated intensive care unit patients, severe hypoxemia, or significant hemodynamic instability.
2. Therapeutic bronchoscopy, complex central airway stenosis, high bleeding risk, procedures requiring advanced interventional techniques, or cases considered unsuitable for novice participation.
3. Complex sampling procedures such as EBUS-TBNA, transbronchial lung biopsy, or cryobiopsy will not be included in the primary endpoint case set and may be analyzed separately as exploratory subgroups or in future studies.
4. Refusal of trainee participation or refusal of procedural recording and/or questionnaire completion.
Primary outcome measure(s)
- Early clinical bronchoscopy performance measured by Ontario Bronchoscopy Assessment Tool (OBAT) technical-diagnostic subscore — From the first eligible supervised clinical bronchoscopy through the 30th eligible supervised clinical bronchoscopy, up to 12 weeks after randomization.
The primary outcome is the normalized partial area under the clinical learning curve across each trainee's first 30 consecutive eligible supervised diagnostic flexible bronchoscopies. The outcome is based on the Ontario Bronchoscopy Assessment Tool (OBAT) technical-diagnostic subscore, comprising items 3-10 and ranging from 8 to 40 points. The normalized partial area under the curve represents the time-averaged performance across procedures 1-30; higher values indicate better early clinical performance.
Trial sites (1)
| Facility | City | Region | Status |
|---|
| China-Japan Friendship Hospital |
Beijing |
Beijing Municipality |
Recruiting |
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