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

Sponsor

China-Japan Friendship Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05799040

Collaborator

(none)

Enrollment

21.1

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Device: Self-developed pulmonary lobar ventilation detector Device: Chartis detection system

Study Design

Study Type:

Observational

Anticipated Enrollment :

40 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Mar 30, 2023

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Self-developed pulmonary lobar ventilation detector	Device: Self-developed pulmonary lobar ventilation detector The participants would evaluated by the self-developed pulmonary lobar ventilation detector.
imported Chartis detection system	Device: Chartis detection system The participants would evaluated by the Chartis detection system.

Arm

Intervention/Treatment

Self-developed pulmonary lobar ventilation detector

Device: Self-developed pulmonary lobar ventilation detector

The participants would evaluated by the self-developed pulmonary lobar ventilation detector.

imported Chartis detection system

Device: Chartis detection system

The participants would evaluated by the Chartis detection system.

Outcome Measures

Primary Outcome Measures

Therapeutic effect of lung volume reduction surgery [1 month after bronchoscopic valve lung volume reduction]
Lung CT
Therapeutic effect of lung volume reduction surgery [3 months after bronchoscopic valve lung volume reduction]
Lung CT
Therapeutic effect of lung volume reduction surgery [6 months after bronchoscopic valve lung volume reduction]
Lung CT
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

China-Japan Friendship Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gang Hou, Principal Investigator, China-Japan Friendship Hospital

ClinicalTrials.gov Identifier:

NCT05799040

Other Study ID Numbers:

2022-NHLHCRF-LX-01-0202-3

First Posted:

Apr 5, 2023

Last Update Posted:

Apr 5, 2023

Last Verified:

Mar 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of Apr 5, 2023