Evaluating a new device for measuring lung ventilation in COPD patients
Evaluation of the Effectiveness of the Self-developed Pulmonary Lobar Ventilation Detector
China-Japan Friendship Hospital · NCT05799040
This study is testing a new device that helps measure lung ventilation in people with COPD to see how well it works compared to existing methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | China-Japan Friendship Hospital (other) |
| Locations | 1 site (BeiJing, Beijing) |
| Trial ID | NCT05799040 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effectiveness of a self-developed pulmonary lobar ventilation detector in patients with Chronic Obstructive Pulmonary Disease (COPD). Participants will use this device alongside the imported Chartis detection system to evaluate pulmonary lobar collateral ventilation. The study focuses on patients who meet specific diagnostic criteria for COPD, including certain lung function parameters and emphysema destruction levels. The goal is to determine how well this new device performs in comparison to established methods.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with COPD who meet the GOLD criteria and have specific lung function metrics.
Not a fit: Patients with severe respiratory failure or other significant lung diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved methods for assessing lung function in COPD patients, potentially enhancing treatment strategies.
How similar studies have performed: While similar studies have explored lung function assessment, the specific use of this self-developed device is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
BeiJing, Beijing
- China-Japan Friendship Hospital — BeiJing, Beijing, China (RECRUITING)
Study contacts
- Study coordinator: Mingming Deng, MD
- Email: isdeng1017@163.com
- Phone: 86 18801336854
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Obstructive Pulmonary Disease