COPD Emphysema Emfyseem
Conditions
Interventions
Bronchoscopic lung volume reduction using Zephyr one-way endobronchial valves (PulmonX USA).
There will be a crossover of the control group to treatment.
Sponsors
UMC-Groningen, Pulmonary diseases
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient > 35 years of age; 2. CT scan indicates heterogeneous emphysema (>25% difference in destruction score between ipsilateral lobes); 3. CT shows ≥ 60% destruction of the target lobe; 4. CT scan indicates intact fissures as assessed on the sagittal reconstructions of a thin slice CT, or previously performed assessment of collateral flow show absence of collateral ventilation; 5. Post- bronchodilator FEV1 100% en RV>150%; 7. Dyspnea score of ≥2 on the mMRC scale of 0-4; 8. Patient has stopped smoking for a minimum of 6 months prior to entering the study; 9. Signed informed Consent; 10. Subject is willing and able to comply with all study testing and procedures according to protocol and guidelines; 11. Lobar exclusion during EBV treatment is achieved.
Exclusion criteria
Exclusion criteria: 1. Hypercapnia defined by PaCO2>8.0 kPa, or hypoxemia defined by PaO2III.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Statistical and clinical significant improvement in both the FVC and FEV1 as well as in the 6 minute walk test. | — |
Secondary
| Measure | Time frame |
|---|---|
| Estimation of costs of BVR compared to care as usual and (historical) costs of LVRS. | — |
Contacts
Public ContactKarin Klooster
Department of Pulmonary Diseases, AA11 University Medical Center Groningen PO Box 30001
Outcome results
None listed