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

17. července 2026 aktualizováno: 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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

110

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

  • Čína
    • Beijing Municipality
      • Beijing, Beijing Municipality, Čína, 100029
        • Nábor
        • China-Japan Friendship Hospital
        • Kontakt:
        • Dílčí vyšetřovatel:
          • Mingming Deng, PhD
        • Vrchní vyšetřovatel:
          • Gang Hou, PhD
        • Kontakt:
        • Dílčí vyšetřovatel:
          • Run Tong, PhD

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Výzkum zdravotnických služeb
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: 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.
Jiný: 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.
Komparátor placeba: 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.
Jiný: 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

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Early clinical bronchoscopy performance measured by Ontario Bronchoscopy Assessment Tool (OBAT) technical-diagnostic subscore
Časové okno: 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.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Time to early clinical competence
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Gang Hou

Spolupracovníci

Anhui Chest Hospital
Shandong Public Health Clinical Center

Vyšetřovatelé

  • Ředitel studie: Gang Hou, PhD, China-Japan Friendship Hospital

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

20. května 2026

Primární dokončení (Odhadovaný)

30. prosince 2027

Dokončení studie (Odhadovaný)

30. prosince 2027

Termíny zápisu do studia

První předloženo

11. července 2026

První předloženo, které splnilo kritéria kontroly kvality

17. července 2026

První zveřejněno (Aktuální)

22. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

22. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

17. července 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další identifikační čísla studie

  • 2024-KY-095

Plán pro data jednotlivých účastníků (IPD)

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ANO

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Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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