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The Role of Standardized Training in the Diagnosis of Interstitial Lung Disease by Transbronchial Lung Cryobiopsy

Study Purpose

The aim of this study was to conduct a prospective randomized controlled trial to design simulator and in vitro lung standardized training, to perform a learning curve evaluation of transbronchial lung cryobiopsy (TBLC) operating physicians, and to assess the role of standardized training in TBLC.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Age ≥18 years.

- suspected ILD.

- ≤3 months since HRCT.

- Forced vital capacity (FVC) ≥50% of predicted value.

- Diffused lung carbon monoxide (DLCO) ≥35% predicted value.

- Echocardiography ≤ 12 months.

- Estimated pulmonary artery systolic pressure ≤40 mmHg.

- Body mass index (BMI) ≤35 kg/m2.

- Patient consent for experimentation.

Exclusion Criteria:

- Patients with platelet counts less than 50 × 109/L or prothrombin time international normalized ratio (INR) higher than 1.5.

- Patients refused to participate in the experiment

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06245954
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	China-Japan Friendship Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Transbronchial Lung Cryobiopsy

Arms & Interventions

Arms

Experimental: Standardized training group

The bronchoscopists in this group will accept simulation training by means of simulators and extracorporeal lungs

Other: Traditional teaching model group

The bronchoscopists in this group will accept traditional lectures, hands-on demonstrations and so on to learn TBLC

Interventions

Other: - simulated training

Simulation training of bronchoscopists by means of simulators and extracorporeal lungs

Other: - traditional bedside teaching

TBLC training for bronchoscopists through traditional lectures, hands-on demonstrations

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Mingming Deng, MD

isdeng1017@163.com

86 18801336854

For additional contact information, you can also visit the trial on clinicaltrials.gov.