Randomized Controlled Trial of Multi-Patient CT-Derived Digital Twin Anatomical Variability Training to Shorten the Clinical Learning Curve for Bronchoscopy
17 de julio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
110
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Gang Hou, PhD
- Número de teléfono: ＋86 13840065481
- Correo electrónico: hougangcmu@163.com
Copia de seguridad de contactos de estudio
- Nombre: Run Tong, PhD
- Número de teléfono: +86 15201507091
- Correo electrónico: tong-run@hotmail.com
Ubicaciones de estudio
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana, 100029
- Reclutamiento
- China-Japan Friendship Hospital
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Contacto:
- Gang Hou, PhD
- Número de teléfono: ＋86 13840065481
- Correo electrónico: hougangcmu@163.com
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Sub-Investigador:
- Mingming Deng, PhD
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Investigador principal:
- Gang Hou, PhD
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Contacto:
- Run Tong, PhD
- Número de teléfono: +86 15201507091
- Correo electrónico: tong-run@hotmail.com
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Sub-Investigador:
- Run Tong, PhD
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: 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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Comparador de placebos: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Early clinical bronchoscopy performance measured by Ontario Bronchoscopy Assessment Tool (OBAT) technical-diagnostic subscore
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Time to early clinical competence
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Gang Hou, PhD, China-Japan Friendship Hospital
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
20 de mayo de 2026
Finalización primaria (Estimado)
30 de diciembre de 2027
Finalización del estudio (Estimado)
30 de diciembre de 2027
Fechas de registro del estudio
Enviado por primera vez
11 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
17 de julio de 2026
Publicado por primera vez (Actual)
22 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
22 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
17 de julio de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 2024-KY-095
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .