Randomized Controlled Trial of Multi-Patient CT-Derived Digital Twin Anatomical Variability Training to Shorten the Clinical Learning Curve for Bronchoscopy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Early clinical bronchoscopy performance measured by Ontario Bronchoscopy Assessment Tool (OBAT) technical-diagnostic subscore
Study Overview
Brief 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.
Detailed Description
The goal of this randomized controlled clinical trial is 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. The study will enroll novice trainees in pulmonary medicine, critical care, thoracic surgery, anesthesiology, or related specialties who have performed ≤5 flexible bronchoscopies and have no prior formal bronchoscopy simulation training.
The main questions it aims to answer are: Whether multi-patient CT-derived digital twin anatomical variability training improves the early clinical learning curve during the first 1-30 supervised real-patient flexible bronchoscopies, as assessed by the Ontario Bronchoscopy Assessment Tool (OBAT) technical-diagnostic subscore.
Participants will:
- Complete baseline assessments, including prior experience, theoretical knowledge testing, confidence evaluation, and spatial ability assessment.
- Be randomized to either:
Multi-patient CT-derived digital twin anatomical variability training, or Anatomically uniform standard-model bronchoscopy simulation training. 3. Undergo standardized bronchoscopy simulation training with equal training duration, feedback intensity, hardware platform, and instructor supervision. 4. Perform standardized post-training simulation transfer tests using previously unseen CT-derived airway models. 5. Perform supervised real-patient low-risk diagnostic flexible bronchoscopies during clinical training. 6. Undergo repeated competency assessments using the Ontario Bronchoscopy Assessment Tool (OBAT), procedural efficiency metrics, and safety evaluations.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Double (Investigator, Outcomes Assessor)
Masking Description
Patient Participants
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Trainee Participants:
- •Residents, fellows, or specialty trainees in pulmonary medicine, critical care medicine, thoracic surgery, anesthesiology, or related specialties whose training programs require flexible bronchoscopy training.
- •Previously performed ≤5 flexible bronchoscopies as primary operator.
- •No prior formal bronchoscopy simulation training course experience.
- •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:
- •Age ≥18 years.
- •Scheduled to undergo elective low-risk or low-to-moderate-risk diagnostic flexible bronchoscopy.
- •Clinically suitable for supervised novice-performed airway inspection, bronchoalveolar lavage, simple brushing, or other low-risk sampling procedures considered safe by the supervising bronchoscopist.
- •Able to understand and provide written informed consent and willing to complete pre-procedure anxiety and post-procedure experience questionnaires.
Exclusion Criteria
- •Trainee Participants:
- •Previously performed >5 flexible bronchoscopies or previously completed a structured bronchoscopy simulation training program.
- •Planned departure from the training program during the study period or anticipated inability to complete follow-up through at least clinical cases 1-
- •Unable to participate in simulation training or unwilling to permit procedural video recording.
- •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:
- •Emergency bronchoscopy, intubated intensive care unit patients, severe hypoxemia, or significant hemodynamic instability.
- •Therapeutic bronchoscopy, complex central airway stenosis, high bleeding risk, procedures requiring advanced interventional techniques, or cases considered unsuitable for novice participation.
- •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.
- •Refusal of trainee participation or refusal of procedural recording and/or questionnaire completion.
Outcomes
Primary Outcomes
Early clinical bronchoscopy performance measured by Ontario Bronchoscopy Assessment Tool (OBAT) technical-diagnostic subscore
Time Frame: 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.
Secondary Outcomes
- Time to early clinical competence(From the first eligible supervised diagnostic flexible bronchoscopy to achievement of early clinical competence, assessed through the 30th eligible procedure, up to 12 weeks after randomization.)
- Overall Clinical Competence Assessed by the Total Ontario Bronchoscopy Assessment Tool Score(From the first eligible supervised clinical bronchoscopy through the 30th eligible supervised clinical bronchoscopy, up to 12 weeks after randomization.)
- Diagnostic Completeness During Transfer Testing(Immediately after completion of the simulation-training curriculum.)
- structured Progression During Transfer Testing(Immediately after completion of the simulation-training curriculum.)
- Procedure Time and Atraumatic Scope-Control Metrics During Transfer Testing(Immediately after completion of the simulation-training curriculum.)
- Technical Performance Assessed by the Bronchoscopy Global Rating Scale, Bronchoscopy Step-by-Step Evaluation Tool, and Bronchoscopy Skills and Tasks Assessment Tool(Immediately after completion of the simulation-training curriculum, during the standardized transfer assessment on an unfamiliar CT-derived airway model.)
- Supervisor Prompting, Takeover, and Safety-Process Events(During each eligible supervised clinical bronchoscopy through completion of immediate postprocedure monitoring.)
- Extended Clinical Learning-Curve Performance(Procedures 31-50 after the first eligible supervised clinical bronchoscopy, up to 18 months after randomization.)
- Patient-Reported Overall Discomfort After Clinical Bronchoscopy(On the day of bronchoscopy, after recovery from sedation and before discharge from the bronchoscopy unit.)
- Patient-Reported Coughing and Choking Sensation After Clinical Bronchoscopy(On the day of bronchoscopy, after recovery from sedation and before discharge from the bronchoscopy unit.)
Investigators
Gang Hou
Chief Physician
China-Japan Friendship Hospital