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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGang Hou

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 1-30.

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Multi-patient CT-derived digital twin anatomical variability training

    Other intervention

    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

    Other intervention

    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

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Multi-patient CT-derived digital twin anatomical variability trainingActive comparator 1 intervention
Group B: Anatomically uniform standard-model bronchoscopy simulation training.Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Early clinical bronchoscopy performance measured by Ontario Bronchoscopy Assessment Tool (OBAT) technical-diagnostic subscore

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.

Time frame
From the first eligible supervised clinical bronchoscopy through the 30th eligible supervised clinical bronchoscopy, up to 12 weeks after randomization.

Secondary outcomes

1

Time to early clinical competence

Number of eligible supervised diagnostic flexible bronchoscopies required for a trainee to achieve early clinical competence. Early clinical competence is achieved on the second of two consecutive eligible procedures in which all of the following criteria are met: (1) the Ontario Bronchoscopy Assessment Tool technical-diagnostic subscore (items 3-10) is at least 32/40; (2) each technical-diagnostic item is scored at least 3/5; (3) no supervisor takeover occurs; and (4) no prespecified safety composite event occurs, including clinically significant hypoxemia requiring intervention or persistent hypoxemia, significant bleeding, early procedure termination, escalation of emergency care, or unplanned supervisor takeover for safety or quality concerns. Participants who do not achieve early clinical competence will be censored at their 30th eligible procedure.

Time frame
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.
2

Overall Clinical Competence Assessed by the Total Ontario Bronchoscopy Assessment Tool Score

Time-averaged total OBAT score across the first 30 eligible supervised clinical bronchoscopies. The total OBAT contains 12 items, each scored from 1 to 5, and evaluates preprocedure planning, sedation and monitoring, technical performance, diagnostic performance, postprocedure management, and communication.

Time frame
From the first eligible supervised clinical bronchoscopy through the 30th eligible supervised clinical bronchoscopy, up to 12 weeks after randomization.
3

Diagnostic Completeness During Transfer Testing

Proportion of the 18 segmental bronchi entered or clearly identified during a standardized post-training assessment on an unfamiliar CT-derived simulated airway model.

Time frame
Immediately after completion of the simulation-training curriculum.
4

structured Progression During Transfer Testing

Number of correct transitions from one bronchial segment to the next anatomically appropriate adjacent segment during a standardized assessment on an unfamiliar CT-derived simulated airway model. Scores range from 0 to 18; higher scores indicate more systematic airway inspection.

Time frame
Immediately after completion of the simulation-training curriculum.

Other outcomes

Sponsors and contacts

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Gang Hou

Lead sponsor

China-Japan Friendship Hospital

Sponsor institution

Anhui Chest Hospital

Collaborator

Shandong Public Health Clinical Center

Collaborator