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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05799040
• Other study ID #: 2022-NHLHCRF-LX-01-0202-3
• Status: Recruiting
• Start date: October 26, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: China-Japan Friendship Hospital
• Contact: Mingming Deng, MD
• Phone: 86 18801336854
• Email: isdeng1017[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• Self-developed pulmonary lobar ventilation detector
The participants would evaluated by the self-developed pulmonary lobar ventilation detector.
• Chartis detection system
The participants would evaluated by the Chartis detection system.

Locations

Country	Name	City	State
China	China-Japan Friendship Hospital	BeiJing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China-Japan Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Therapeutic effect of lung volume reduction surgery	Lung CT	1 month after bronchoscopic valve lung volume reduction
Primary	Therapeutic effect of lung volume reduction surgery	Lung CT	3 months after bronchoscopic valve lung volume reduction
Primary	Therapeutic effect of lung volume reduction surgery	Lung CT	6 months after bronchoscopic valve lung volume reduction
Primary	the integrity of interlobar fissure	Use the self-developed pulmonary lobar ventilation detector and the imported Chartis detection system to evaluate the target pulmonary lobar collateral ventilation	Before bronchoscopic valve lung volume reduction