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

Обзор

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.

Подробное описание

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:

1. Complete baseline assessments, including prior experience, theoretical knowledge testing, confidence evaluation, and spatial ability assessment. 2. 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.

Real-patient participants undergoing low-risk diagnostic bronchoscopy will also complete peri-procedural questionnaires evaluating anxiety, discomfort, cough/choking sensation, satisfaction, and willingness to undergo repeat bronchoscopy.

Вмешательства

• Другое 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 effi
• Другое 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

Первичные конечные точки

• Early clinical bronchoscopy performance measured by Ontario Bronchoscopy Assessment Tool (OBAT) technical-diagnostic subscore [Срок оценки: From the first eligible supervised clinical bronchoscopy through the 30th eligible supervised clinical bronchoscopy, up to 12 weeks after randomization.]

Вторичные конечные точки (10)

• Time to early clinical competence [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Immediately after completion of the simulation-training curriculum.]
• structured Progression During Transfer Testing [Срок оценки: Immediately after completion of the simulation-training curriculum.]
• Procedure Time and Atraumatic Scope-Control Metrics During Transfer Testing [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: During each eligible supervised clinical bronchoscopy through completion of immediate postprocedure monitoring.]
• Extended Clinical Learning-Curve Performance [Срок оценки: Procedures 31-50 after the first eligible supervised clinical bronchoscopy, up to 18 months after randomization.]
• Patient-Reported Overall Discomfort After Clinical Bronchoscopy [Срок оценки: 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 [Срок оценки: On the day of bronchoscopy, after recovery from sedation and before discharge from the bronchoscopy unit.]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Организация здравоохранения

Центры проведения

Китай · 1 центр

• China-Japan Friendship Hospital — Пекин

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07718451 · 2024-KY-095

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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