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

NCT05799040 | Recruiting

• 1 other identifier: 2022-NHLHCRF-LX-01-0202-3
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (4)

• Therapeutic effect of lung volume reduction surgery

  Lung CT

  1 month after bronchoscopic valve lung volume reduction

• Therapeutic effect of lung volume reduction surgery

  Lung CT

  3 months after bronchoscopic valve lung volume reduction

• Therapeutic effect of lung volume reduction surgery

  Lung CT

  6 months after bronchoscopic valve lung volume reduction

• 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

Study Arms (2)

Self-developed pulmonary lobar ventilation detector

Device: Self-developed pulmonary lobar ventilation detector

imported Chartis detection system

Device: Chartis detection system

Interventions

Self-developed pulmonary lobar ventilation detector DEVICE

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

Self-developed pulmonary lobar ventilation detector

Chartis detection system DEVICE

The participants would evaluated by the Chartis detection system.

imported Chartis detection system

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chronic obstructive pulmonary disease

You may qualify if:

• 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

You may not qualify if:

• PaCO2\>8.0 kPa, or PaO2\<6.0 kPa
• 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

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mingming Deng, MD

CONTACT

86 18801336854; isdeng1017@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: April 5, 2023
• Study Start: October 26, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Locations

CN (1)