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

NCT07718451 | Recruiting DMC

• 1 other identifier: 2024-KY-095
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchoscopy; Learning Curves and Outcomes of Simulation-based Training; Learning Curve

Keywords

bronchoscopy; learning curve

Outcome Measures

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.

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

Secondary Outcomes (10)

• 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.

Study Arms (2)

Multi-patient CT-derived digital twin anatomical variability training

ACTIVE COMPARATOR

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.

Other: Multi-patient CT-derived digital twin anatomical variability training

Anatomically uniform standard-model bronchoscopy simulation training.

PLACEBO COMPARATOR

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.

Other: Anatomically uniform standard-model bronchoscopy simulation training

Interventions

Anatomically uniform standard-model bronchoscopy simulation training OTHER

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

Anatomically uniform standard-model bronchoscopy simulation training.

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

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.

Multi-patient CT-derived digital twin anatomical variability training

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 1-30.
• 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.
• 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.

Sponsors & Collaborators

• Gang Hou: lead
• Anhui Chest Hospital: collaborator
• Shandong Public Health Clinical Center: collaborator

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

Related Publications (7)

• Ost D, DeRosiers A, Britt EJ, Fein AM, Lesser ML, Mehta AC. Assessment of a bronchoscopy simulator. Am J Respir Crit Care Med. 2001 Dec 15;164(12):2248-55. doi: 10.1164/ajrccm.164.12.2102087.

  PMID: 11751195 RESULT

• Kennedy CC, Maldonado F, Cook DA. Simulation-based bronchoscopy training: systematic review and meta-analysis. Chest. 2013 Jul;144(1):183-192. doi: 10.1378/chest.12-1786.

  PMID: 23370487 RESULT

• Davoudi M, Osann K, Colt HG. Validation of two instruments to assess technical bronchoscopic skill using virtual reality simulation. Respiration. 2008;76(1):92-101. doi: 10.1159/000126493. Epub 2008 Apr 11.

  PMID: 18408359 RESULT

• Cold KM, Svendsen MBS, Bodtger U, Nayahangan LJ, Clementsen PF, Konge L. Using structured progress to measure competence in flexible bronchoscopy. J Thorac Dis. 2020 Nov;12(11):6797-6805. doi: 10.21037/jtd-20-2181.

  PMID: 33282381 RESULT

• Deng M, Li F, Tang F, Chen W, Wang F, Tang CL, Tong R, Yang Z, Xu W, Zhang N, Xia Y, Li S, Herth FJF, Hou G. Digital twin-based bronchoscopy simulator improves training performance and skill retention of novices: a randomised controlled study. Thorax. 2026 Apr 16;81(5):483-491. doi: 10.1136/thorax-2025-223147.

  PMID: 41207791 RESULT

• Voduc N, Adamson R, Kashgari A, Fenton M, Porhownick N, Wojnar M, Sharma K, Gillson AM, Chung C, McConnell M. Development of Learning Curves for Bronchoscopy: Results of a Multicenter Study of Pulmonary Trainees. Chest. 2020 Dec;158(6):2485-2492. doi: 10.1016/j.chest.2020.06.046. Epub 2020 Jul 3.

  PMID: 32622822 RESULT

• Voduc N, Dudek N, Parker CM, Sharma KB, Wood TJ. Development and Validation of a Bronchoscopy Competence Assessment Tool in a Clinical Setting. Ann Am Thorac Soc. 2016 Apr;13(4):495-501. doi: 10.1513/AnnalsATS.201508-548OC.

  PMID: 26862890 RESULT

Study Officials

• Gang Hou, PhD

  China-Japan Friendship Hospital

  STUDY DIRECTOR

Central Study Contacts

Gang Hou, PhD

CONTACT

＋86 13840065481; hougangcmu@163.com

Run Tong, PhD

CONTACT

+86 15201507091; tong-run@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patient Participants
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Model Details: This is a parallel-group randomized controlled trial in which novice bronchoscopists are assigned to either multi-patient CT-derived digital twin anatomical variability simulation training or standard anatomically uniform bronchoscopy simulation training. Each participant receives only one type of training. The intervention groups are balanced in duration, instructor supervision, and hardware platform. Following simulation, participants perform supervised real-patient flexible bronchoscopies, and learning curves, procedural efficiency, competency, and patient-centered outcomes are assessed over the first 30 clinical cases, with extended follow-up for exploratory analysis. This design allows comparison of early clinical skill acquisition and patient experience between the two training methods.

Study Record Dates

• First Submitted: July 11, 2026
• First Posted: July 22, 2026
• Study Start: May 20, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: July 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)