Bronchoscopische Longvolume Reductie door middel van éénrichtingsventielen in patiënten met ernstig COPD.
Completed
- Conditions
- COPDEmphysemaEmfyseem
- Registration Number
- NL-OMON23581
- Lead Sponsor
- MC-Groningen, Pulmonary diseases
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 68
Inclusion Criteria
1. Patient > 35 years of age;
2. CT scan indicates heterogeneous emphysema (>25% difference in destruction score between ipsilateral lobes);
Exclusion Criteria
1. Hypercapnia defined by PaCO2>8.0 kPa, or hypoxemia defined by PaO2<6.0kPa, both measured on room air;
2. 6MWT <140 meters;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Statistical and clinical significant improvement in both the FVC and FEV1 as well as in the 6 minute walk test.
- Secondary Outcome Measures
Name Time Method Estimation of costs of BVR compared to care as usual and (historical) costs of LVRS.