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.
調査の概要
状態
募集
詳細な説明
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:
- 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.
- Undergo standardized bronchoscopy simulation training with equal training duration, feedback intensity, hardware platform, and instructor supervision.
- Perform standardized post-training simulation transfer tests using previously unseen CT-derived airway models.
- Perform supervised real-patient low-risk diagnostic flexible bronchoscopies during clinical training.
- 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.
研究の種類
介入
入学 (推定)
110
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Gang Hou, PhD
- 電話番号：＋86 13840065481
- メール：hougangcmu@163.com
研究連絡先のバックアップ
- 名前：Run Tong, PhD
- 電話番号：+86 15201507091
- メール：tong-run@hotmail.com
研究場所
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Beijing Municipality
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Beijing、Beijing Municipality、中国、100029
- 募集
- China-Japan Friendship Hospital
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コンタクト：
- Gang Hou, PhD
- 電話番号：＋86 13840065481
- メール：hougangcmu@163.com
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副調査官：
- Mingming Deng, PhD
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主任研究者：
- Gang Hou, PhD
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コンタクト：
- Run Tong, PhD
- 電話番号：+86 15201507091
- メール：tong-run@hotmail.com
-
副調査官：
- Run Tong, PhD
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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 1-30.
- 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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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.
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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.
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プラセボコンパレーター：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.
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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
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Early clinical bronchoscopy performance measured by Ontario Bronchoscopy Assessment Tool (OBAT) technical-diagnostic subscore
時間枠：From the first eligible supervised clinical bronchoscopy through the 30th eligible supervised clinical bronchoscopy, up to 12 weeks after randomization.
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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.
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From the first eligible supervised clinical bronchoscopy through the 30th eligible supervised clinical bronchoscopy, up to 12 weeks after randomization.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Time to early clinical competence
時間枠：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.
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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.
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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.
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Overall Clinical Competence Assessed by the Total Ontario Bronchoscopy Assessment Tool Score
時間枠：From the first eligible supervised clinical bronchoscopy through the 30th eligible supervised clinical bronchoscopy, up to 12 weeks after randomization.
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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.
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From the first eligible supervised clinical bronchoscopy through the 30th eligible supervised clinical bronchoscopy, up to 12 weeks after randomization.
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Diagnostic Completeness During Transfer Testing
時間枠：Immediately after completion of the simulation-training curriculum.
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Proportion of the 18 segmental bronchi entered or clearly identified during a standardized post-training assessment on an unfamiliar CT-derived simulated airway model.
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Immediately after completion of the simulation-training curriculum.
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structured Progression During Transfer Testing
時間枠：Immediately after completion of the simulation-training curriculum.
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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.
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Immediately after completion of the simulation-training curriculum.
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Procedure Time and Atraumatic Scope-Control Metrics During Transfer Testing
時間枠：Immediately after completion of the simulation-training curriculum.
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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.
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Immediately after completion of the simulation-training curriculum.
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Technical Performance Assessed by the Bronchoscopy Global Rating Scale, Bronchoscopy Step-by-Step Evaluation Tool, and Bronchoscopy Skills and Tasks Assessment Tool
時間枠：Immediately after completion of the simulation-training curriculum, during the standardized transfer assessment on an unfamiliar CT-derived airway model.
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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.
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Supervisor Prompting, Takeover, and Safety-Process Events
時間枠：During each eligible supervised clinical bronchoscopy through completion of immediate postprocedure monitoring.
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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.
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During each eligible supervised clinical bronchoscopy through completion of immediate postprocedure monitoring.
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Extended Clinical Learning-Curve Performance
時間枠：Procedures 31-50 after the first eligible supervised clinical bronchoscopy, up to 18 months after randomization.
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Normalized partial area under the learning curve for the OBAT technical-diagnostic subscore during eligible supervised clinical bronchoscopies 31-50.
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Procedures 31-50 after the first eligible supervised clinical bronchoscopy, up to 18 months after randomization.
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Patient-Reported Overall Discomfort After Clinical Bronchoscopy
時間枠：On the day of bronchoscopy, after recovery from sedation and before discharge from the bronchoscopy unit.
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Patient-reported overall discomfort measured using a 0-10 visual analog scale, where 0 indicates no discomfort and 10 indicates the worst imaginable discomfort.
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On the day of bronchoscopy, after recovery from sedation and before discharge from the bronchoscopy unit.
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Patient-Reported Coughing and Choking Sensation After Clinical Bronchoscopy
時間枠：On the day of bronchoscopy, after recovery from sedation and before discharge from the bronchoscopy unit.
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Patient-reported coughing and choking sensation measured using prespecified 0-10 visual analog scales or prespecified Likert scales.
Higher scores indicate worse symptoms.
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On the day of bronchoscopy, after recovery from sedation and before discharge from the bronchoscopy unit.
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- スタディディレクター：Gang Hou, PhD、China-Japan Friendship Hospital
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年5月20日
一次修了 (推定)
2027年12月30日
研究の完了 (推定)
2027年12月30日
試験登録日
最初に提出
2026年7月11日
QC基準を満たした最初の提出物
2026年7月17日
最初の投稿 (実際)
2026年7月22日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月22日
QC基準を満たした最後の更新が送信されました
2026年7月17日
最終確認日
2026年5月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。