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

C

China-Japan Friendship Hospital

Status

Enrolling

Conditions

Transbronchial Lung Cryobiopsy

Treatments

Other: simulated training
Other: traditional bedside teaching

Study type

Interventional

Funder types

Other

Identifiers

NCT06245954
ZRJY2021-BJ08-03-02

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 2 patient groups

Standardized training group
Experimental group
Description:
The bronchoscopists in this group will accept simulation training by means of simulators and extracorporeal lungs
Treatment:
Other: simulated training
Traditional teaching model group
Other group
Description:
The bronchoscopists in this group will accept traditional lectures, hands-on demonstrations and so on to learn TBLC
Treatment:
Other: traditional bedside teaching

Trial contacts and locations

1

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Central trial contact

Mingming Deng, MD

Data sourced from clinicaltrials.gov

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