Evaluation of the Effectiveness of the Self-developed Pulmonary Lobar Ventilation Detector

Recruiting

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Device: Self-developed pulmonary lobar ventilation detector; Device: Chartis detection system

• Registration Number: NCT05799040
• Lead Sponsor: China-Japan Friendship Hospital

Brief Summary

The goal of observational study is to Evaluation of the effectiveness of the self-developed pulmonary lobar ventilation detector in Chronic Obstructive Pulmonary Disease. The main question it aims to answer are:Evaluation of the effectiveness of the self-developed pulmonary lobar ventilation detector.

Participants will use the self-developed pulmonary lobar ventilation detector and the imported Chartis detection system to evaluate the target pulmonary lobar collateral ventilation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-09
• Study First Submitted QC: 2023-03-22
• Study First Posted: 2023-04-05
• Study Start: 2023-10-26
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-11
• Last Update Posted: 2024-03-12
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients with chronic obstructive pulmonary disease who meet the GOLD diagnostic criteria
• FEV1 ≤ 45% pred and FEV1/FVC<70%
• TLC>100% pred and RV>175% pred
• CAT≥18
• >50% of emphysema destruction
• Smoking prohibition>6 months
• Sign the informed consent form

Exclusion Criteria

• PaCO2>8.0 kPa, or PaO2<6.0 kPa
• 6-minute walking test<160m
• Obvious chronic bronchitis, bronchiectasis or other infectious lung diseases
• Three hospitalizations due to pulmonary infection in the past 12 months before the baseline assessment
• Previous lobectomy, LVRS or lung transplantation
• LVEF<45% and or RVSP>50mmHg
• Anticoagulant therapy that cannot be stopped before surgery
• The patient has obvious immune deficiency
• Participated in other lung drug studies within 30 days before this study
• Pulmonary nodules requiring intervention
• Any disease or condition that interferes with the completion of the initial or subsequent assessment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Self-developed pulmonary lobar ventilation detector	Self-developed pulmonary lobar ventilation detector	-
imported Chartis detection system	Chartis detection system	-

Primary Outcome Measures

Name	Time	Method
the integrity of interlobar fissure	Before bronchoscopic valve lung volume reduction	Use the self-developed pulmonary lobar ventilation detector and the imported Chartis detection system to evaluate the target pulmonary lobar collateral ventilation
Therapeutic effect of lung volume reduction surgery	6 months after bronchoscopic valve lung volume reduction	Lung CT

Trial Locations

Locations (1)

China-Japan Friendship Hospital; 🇨🇳 BeiJing, Beijing, China