Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

17. juli 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

110

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100029
        • Rekruttering
        • China-Japan Friendship Hospital
        • Kontakt:
        • Underforsker:
          • Mingming Deng, PhD
        • Ledende efterforsker:
          • Gang Hou, PhD
        • Kontakt:
        • Underforsker:
          • Run Tong, PhD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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.
Andet: 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.
Placebo komparator: 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.
Andet: 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Early clinical bronchoscopy performance measured by Ontario Bronchoscopy Assessment Tool (OBAT) technical-diagnostic subscore
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to early clinical competence
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Gang Hou

Samarbejdspartnere

Anhui Chest Hospital
Shandong Public Health Clinical Center

Efterforskere

  • Studieleder: Gang Hou, PhD, China-Japan Friendship Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

20. maj 2026

Primær færdiggørelse (Anslået)

30. december 2027

Studieafslutning (Anslået)

30. december 2027

Datoer for studieregistrering

Først indsendt

11. juli 2026

Først indsendt, der opfyldte QC-kriterier

17. juli 2026

Først opslået (Faktiske)

22. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. juli 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 2024-KY-095

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Jamaica

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner