Multi-patient CT-derived Digital Twin Training to Shorten the Bronchoscopy Learning Curve

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized trial compares two bronchoscopy training approaches for novices with ≤5 prior bronchoscopies and no formal simulation training. Participants are randomized to receive either multi-patient CT-derived digital twin anatomical variability training or conventional anatomically uniform simulation training, with equal training duration and supervision. The primary outcome is the early learning curve during the first 1-30 supervised real-patient bronchoscopies, measured by the OBAT technical-diagnostic subscore. Baseline assessments include prior experience, knowledge tests, confidence, and spatial ability. Post-training transfer tests use unseen CT-derived airway models to evaluate skills in a simulated-to-clinical transfer setting.

Why it matters

Who can join: the full rules

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.

Where it's running

• China-Japan Friendship Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Gang Hou, PhD
• Email: hougangcmu@163.com
• Phone: ＋86 13840065481

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.