此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

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

2026年7月17日 更新者：Gang Hou
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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

110

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 中国
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100029
        • 招聘中
        • China-Japan Friendship Hospital
        • 接触：
        • 副研究员：
          • Mingming Deng, PhD
        • 首席研究员：
          • Gang Hou, PhD
        • 接触：
        • 副研究员：
          • Run Tong, PhD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：卫生服务研究
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
有源比较器：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 efficiency, and early clinical bronchoscopy performance.
其他：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 efficiency, and early clinical bronchoscopy performance.
安慰剂比较：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.
其他：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

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Early clinical bronchoscopy performance measured by Ontario Bronchoscopy Assessment Tool (OBAT) technical-diagnostic subscore
大体时间：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.
From the first eligible supervised clinical bronchoscopy through the 30th eligible supervised clinical bronchoscopy, up to 12 weeks after randomization.

次要结果测量

结果测量
措施说明
大体时间
Time to early clinical competence
大体时间：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.
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.
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
大体时间：From the first eligible supervised clinical bronchoscopy through the 30th eligible supervised clinical bronchoscopy, up to 12 weeks after randomization.
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.
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
大体时间：Immediately after completion of the simulation-training curriculum.
Proportion of the 18 segmental bronchi entered or clearly identified during a standardized post-training assessment on an unfamiliar CT-derived simulated airway model.
Immediately after completion of the simulation-training curriculum.
structured Progression During Transfer Testing
大体时间：Immediately after completion of the simulation-training curriculum.
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.
Immediately after completion of the simulation-training curriculum.
Procedure Time and Atraumatic Scope-Control Metrics During Transfer Testing
大体时间：Immediately after completion of the simulation-training curriculum.
Total task completion time, mean intersegmental time, and simulator-recorded wall-contact, red-screen, or loss-of-visualization metrics during assessment on an unfamiliar CT-derived simulated airway model.
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
大体时间：Immediately after completion of the simulation-training curriculum, during the standardized transfer assessment on an unfamiliar CT-derived airway model.

Technical performance during a standardized transfer assessment on an unfamiliar CT-derived simulated airway model will be independently scored by blinded assessors using the Bronchoscopy Global Rating Scale (BGRS), Bronchoscopy Stepwise Evaluation Tool (BSET), and the abbreviated Bronchoscopy Skills and Tasks Assessment Tool (BSTAT).

The BGRS ranges from 0 to 39 points and assesses segmental-anatomy identification, bronchoscope manipulation, task performance, and posture/hand position. The BSET ranges from 0 to 100 points and comprises the 39-point BGRS and the 61-point Bronchoscopy Exercises Rating Scale; it assesses global bronchoscopy performance and completion of progressively more difficult airway-navigation exercises. The abbreviated BSTAT ranges from 0 to 24 points and assesses technical bronchoscopy skills during the standardized simulation assessment.

For all three instruments, higher scores indicate better technical performance. BGRS, BSET, and abbreviated BSTAT scores wi
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
大体时间：During each eligible supervised clinical bronchoscopy through completion of immediate postprocedure monitoring.
Number of verbal prompts, supervisor takeover, procedure interruption, additional sedation, and prespecified safety composite events during eligible supervised clinical bronchoscopies. The safety composite includes clinically significant hypoxemia requiring intervention or persistent hypoxemia, significant bleeding, early termination, escalation of emergency care, or unplanned supervisor takeover for safety or quality.
During each eligible supervised clinical bronchoscopy through completion of immediate postprocedure monitoring.
Extended Clinical Learning-Curve Performance
大体时间：Procedures 31-50 after the first eligible supervised clinical bronchoscopy, up to 18 months after randomization.
Normalized partial area under the learning curve for the OBAT technical-diagnostic subscore during eligible supervised clinical bronchoscopies 31-50.
Procedures 31-50 after the first eligible supervised clinical bronchoscopy, up to 18 months after randomization.
Patient-Reported Overall Discomfort After Clinical Bronchoscopy
大体时间：On the day of bronchoscopy, after recovery from sedation and before discharge from the bronchoscopy unit.
Patient-reported overall discomfort measured using a 0-10 visual analog scale, where 0 indicates no discomfort and 10 indicates the worst imaginable discomfort.
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
大体时间：On the day of bronchoscopy, after recovery from sedation and before discharge from the bronchoscopy unit.
Patient-reported coughing and choking sensation measured using prespecified 0-10 visual analog scales or prespecified Likert scales. Higher scores indicate worse symptoms.
On the day of bronchoscopy, after recovery from sedation and before discharge from the bronchoscopy unit.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Gang Hou

合作者

Anhui Chest Hospital
Shandong Public Health Clinical Center

调查人员

  • 研究主任：Gang Hou, PhD、China-Japan Friendship Hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月20日

初级完成 (估计的)

2027年12月30日

研究完成 (估计的)

2027年12月30日

研究注册日期

首次提交

2026年7月11日

首先提交符合 QC 标准的

2026年7月17日

首次发布 (实际的)

2026年7月22日

研究记录更新

最后更新发布 (实际的)

2026年7月22日

上次提交的符合 QC 标准的更新

2026年7月17日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • 2024-KY-095

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅