BronchoscopyNCT07718451
Randomized Controlled Trial of Multi-Patient CT-Derived Digital Twin Anatomical Variability Training to Shorten the Clinical Learning Curve for Bronchoscopy
A study testing Multi-patient CT-derived digital twin anatomical variability training and Anatomically uniform standard-model bronchoscopy simulation training in people with Bronchoscopy and Learning Curves and Outcomes of Simulation-based Training, run by Gang Hou at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bronchoscopy, Learning Curves and Outcomes of Simulation-based Training, Learning Curve
- What is being tested?
- Multi-patient CT-derived digital twin anatomical variability training and Anatomically uniform standard-model bronchoscopy simulation training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2026to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 10Show fewer
- 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.
Who cannot join
- 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:
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Gang Hou, PhD, ＋86 13840065481, hougangcmu@163.com
Run Tong, PhD, +86 15201507091, tong-run@hotmail.com
About this study
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.
Read the detailed description
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.
- Being tested
- Multi-patient CT-derived digital twin anatomical variability training, Anatomically uniform standard-model bronchoscopy simulation training
- Keywords
- bronchoscopy, learning curve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-patient CT-derived digital twin anatomical variability trainingOther
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.
Anatomically uniform standard-model bronchoscopy simulation trainingOther
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
| Study group | Role | What they receive |
|---|---|---|
| Multi-patient CT-derived digital twin anatomical variability training | Active comparator | 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. Receives: Other: Multi-patient CT-derived digital twin anatomical variability training |
| Anatomically uniform standard-model bronchoscopy simulation training. | Placebo comparator | 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. Receives: Other: Anatomically uniform standard-model bronchoscopy simulation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early clinical bronchoscopy performance measured by Ontario Bronchoscopy Assessment Tool (OBAT) technical-diagnostic subscore
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.
Measured: From the first eligible supervised clinical bronchoscopy through the 30th eligible supervised clinical bronchoscopy, up to 12 weeks after randomization.
Secondary outcomes (10)
Time to early clinical competence
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.
Measured: 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
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.
Measured: 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
Proportion of the 18 segmental bronchi entered or clearly identified during a standardized post-training assessment on an unfamiliar CT-derived simulated airway model.
Measured: Immediately after completion of the simulation-training curriculum.
structured Progression During Transfer Testing
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.
Measured: Immediately after completion of the simulation-training curriculum.
Procedure Time and Atraumatic Scope-Control Metrics During Transfer Testing
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.
Measured: 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
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
Measured: 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
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.
Measured: During each eligible supervised clinical bronchoscopy through completion of immediate postprocedure monitoring.
Extended Clinical Learning-Curve Performance
Normalized partial area under the learning curve for the OBAT technical-diagnostic subscore during eligible supervised clinical bronchoscopies 31-50.
Measured: Procedures 31-50 after the first eligible supervised clinical bronchoscopy, up to 18 months after randomization.
Patient-Reported Overall Discomfort After Clinical Bronchoscopy
Patient-reported overall discomfort measured using a 0-10 visual analog scale, where 0 indicates no discomfort and 10 indicates the worst imaginable discomfort.
Measured: 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
Patient-reported coughing and choking sensation measured using prespecified 0-10 visual analog scales or prespecified Likert scales. Higher scores indicate worse symptoms.
Measured: On the day of bronchoscopy, after recovery from sedation and before discharge from the bronchoscopy unit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start20 May 2026
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for BronchoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a parallel-group randomized controlled trial in which novice bronchoscopists are assigned to either multi-patient CT-derived digital twin anatomical variability simulation training or standard anatomically uniform bronchoscopy simulation training. Each participant receives only one type of training. The intervention groups are balanced in duration, instructor supervision, and hardware platform. Following simulation, participants perform supervised real-patient flexible bronchoscopies, and learning curves, procedural efficiency, competency, and patient-centered outcomes are assessed over the first 30 clinical cases, with extended follow-up for exploratory analysis. This design allows comparison of early clinical skill acquisition and patient experience between the two training methods.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gang Hou
- Sponsor type
- University, hospital or other
- Collaborators
- Anhui Chest Hospital, Shandong Public Health Clinical Center
- Responsible party
- Sponsor-investigator, Gang Hou, China-Japan Friendship Hospital
- Investigators
- Gang Hou, PhD, Study director, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07718451
- Sponsor's protocol ID
- 2024-KY-095
- Status last verified
- May 2026
- First submitted
- 11 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 11751195Kennedy 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.
PubMed 23370487Davoudi 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.
PubMed 18408359Cold 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.
PubMed 33282381Deng 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.
PubMed 41207791Voduc 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.
PubMed 32622822Voduc 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.
PubMed 26862890
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Multi-Patient CT-Derived Digital Twin Anatomical Variability Training to Shorten the Clinical Learning Curve for Bronchoscopy
- ClinicalTrials.gov ID
- NCT07718451
- Acronym / sponsor ID
- 2024-KY-095
- Keywords
- bronchoscopy, learning curve
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Gang HouUniversity, hospital or other
- Collaborators
- Anhui Chest Hospital, Shandong Public Health Clinical Center
- Study start
- 20 May 2026 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a parallel-group randomized controlled trial in which novice bronchoscopists are assigned to either multi-patient CT-derived digital twin anatomical variability simulation training or standard anatomically uniform bronchoscopy simulation training. Each participant receives only one type of training. The intervention groups are balanced in duration, instructor supervision, and hardware platform. Following simulation, participants perform supervised real-patient flexible bronchoscopies, and learning curves, procedural efficiency, competency, and patient-centered outcomes are assessed over the first 30 clinical cases, with extended follow-up for exploratory analysis. This design allows comparison of early clinical skill acquisition and patient experience between the two training methods.
| Arm | Type | Receives |
|---|---|---|
| Multi-patient CT-derived digital twin anatomical variability training | Active comparator | Other: Multi-patient CT-derived digital twin anatomical variability trainingParticipants 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. |
| Anatomically uniform standard-model bronchoscopy simulation training. | Placebo comparator | Other: Anatomically uniform standard-model bronchoscopy simulation trainingParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
- Age ≥18 years.
Key exclusion criteria (10 listed)
- 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.
- Emergency bronchoscopy, intubated intensive care unit patients, severe hypoxemia, or significant hemodynamic instability.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-patient CT-derived digital twin anatomical variability trainingParticipants 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. | Other | Multi-patient CT-derived digital twin anatomical variability training |
| Anatomically uniform standard-model bronchoscopy simulation trainingParticipants 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 | Other | Anatomically uniform standard-model bronchoscopy simulation training. |
Primary outcome
Early clinical bronchoscopy performance measured by Ontario Bronchoscopy Assessment Tool (OBAT) technical-diagnostic subscore
Time frame: 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.
10 secondary outcomes
Time to early clinical competence
Time frame: 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
Time frame: 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
Time frame: Immediately after completion of the simulation-training curriculum.
structured Progression During Transfer Testing
Time frame: Immediately after completion of the simulation-training curriculum.
Procedure Time and Atraumatic Scope-Control Metrics During Transfer Testing
Time frame: 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
Time frame: 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
Time frame: During each eligible supervised clinical bronchoscopy through completion of immediate postprocedure monitoring.
Extended Clinical Learning-Curve Performance
Time frame: Procedures 31-50 after the first eligible supervised clinical bronchoscopy, up to 18 months after randomization.
Patient-Reported Overall Discomfort After Clinical Bronchoscopy
Time frame: 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
Time frame: On the day of bronchoscopy, after recovery from sedation and before discharge from the bronchoscopy unit.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Results publication: PubMed 11751195Ost 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.
- Results publication: PubMed 23370487Kennedy 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.
- Results publication: PubMed 18408359Davoudi 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.
- Results publication: PubMed 33282381Cold 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.
- Results publication: PubMed 41207791Deng 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.
- Results publication: PubMed 32622822Voduc 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.
- Results publication: PubMed 26862890Voduc 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gang Hou, PhD study director
China-Japan Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-patient CT-derived digital twin anatomical variability training and Anatomically uniform standard-model bronchoscopy simulation training in people with Bronchoscopy and Learning Curves and Outcomes of Simulation-based Training, run by Gang Hou at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gang Hou, PhD (＋86 13840065481, hougangcmu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early clinical bronchoscopy performance measured by Ontario Bronchoscopy Assessment Tool (OBAT) technical-diagnostic subscore (time frame: From the first eligible supervised clinical bronchoscopy through the 30th eligible supervised clinical bronchoscopy, up to 12 weeks after randomization.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07718451, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.