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

March 11, 2024 updated by: Gang Hou, China-Japan Friendship Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • BeiJing, Beijing, China, 100029
        • Recruiting
        • China-Japan Friendship Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Chronic obstructive pulmonary disease

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
imported Chartis detection system
Device: Chartis detection system
The participants would evaluated by the Chartis detection system.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Therapeutic effect of lung volume reduction surgery
Time Frame: 1 month after bronchoscopic valve lung volume reduction
Lung CT
1 month after bronchoscopic valve lung volume reduction
Therapeutic effect of lung volume reduction surgery
Time Frame: 3 months after bronchoscopic valve lung volume reduction
Lung CT
3 months after bronchoscopic valve lung volume reduction
Therapeutic effect of lung volume reduction surgery
Time Frame: 6 months after bronchoscopic valve lung volume reduction
Lung CT
6 months after bronchoscopic valve lung volume reduction
the integrity of interlobar fissure
Time Frame: 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
Before bronchoscopic valve lung volume reduction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China-Japan Friendship Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 26, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

March 9, 2023

First Submitted That Met QC Criteria

March 22, 2023

First Posted (Actual)

April 5, 2023

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-NHLHCRF-LX-01-0202-3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Obstructive Pulmonary Disease

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in China

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe