About this trial
The goal of this pliot study al is to preliminarily evaluate the effectiveness and safety of transbronchial lung volume reduction surgery using the self-devloped endobronchial valves for chronic obstructive pulmonary disease patients with emphysema phenotype . The main questions it aims to answer are:
Does self-devloped endobronchial valves improve the lung function、exercise capacity and symptons of participants? What surgery-related adverse events do participants have after transbronchial lung volume reduction surgery using the self-devloped endobronchial valves?
Participants will:
undergo transbronchial lung volume reduction surgery using the self-devloped endobronchial valves.
receive follow-up before surgery (baseline) and 3 days, 4 weeks, 12weeks after surgery.
Eligibility criteria
Qualifiers
1. Patients with chronic obstructive pulmonary disease based on GOLD diagnostic criteria;
2. Age range from 40 to 85 years old (including 40 and 85 years old);
3. BMI ≤ 35kg/m2;
4. 15% ≤ FEV1% pred ≤ 45%;
Disqualifiers
1. Being pregnant or breastfeeding;
2. PaCO2>50mmHg and/or PaO2<45mmHg;
3. Obvious bronchiectasis or other infectious lung diseases;
4. Hospitalization due to pulmonary infection or acute exacerbation of COPD within the past 12 months prior to baseline assessment twice or more times;
Trial design
Treatments tested in this trial
- bronchoscopic lung volume reduction surgery using endobronchial valve