COPD concomitant with severe lung emphysema
Conditions
Interventions
Group 1: Patients with severe lung emphysema undergoing lung volume reduction surgery (LVRS) or endoscopic lung volume reduction (ELVR) with the endobronchial implantation of valves.
Before treatment
Sponsors
Department of Pneumology-Charité - Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • The medication of COPD patients must be adjusted excellent • A proof of nicotin restriction for over 3 months (COHb50mmHg a consultation in a center for pulmonary hypertension is required. • Dyspnea must be caused primarily due to hyperinflation • The following cutoff criteria are established for the lung function: FEV1180%, total lung volume (TLC) >100% • Significant limitation of patients mobility, defined by the 6-minutes walking test <450m • Software dependent quantification of emphysema score per lung lobe, as shown in computed tomography • For the treatment with valves: absence of collateral ventilation in the target lobe assessed by Chartis ® assessment in a bronchoscopy or by software dependent analysis of fissure integrity
Exclusion criteria
Exclusion criteria: -Patients with a significant hypercapnia (pCO2 <55mmHg) - Absence of collateral ventilation for implantation of endobronchial valves -Current cigarette smoking
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary hypothesis of the study is to find out which treatment strategy results in a higher improvement of FEV1 over time. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary hypothesis is to determine the treatment approaches that contribute to a crucial clinical improvement that contribute to a crucial improvement of the patients quality of life ((6-MWT CAT, MMRC, SGRQ). | — |
Countries
Germany
Contacts
Public ContactChristian Grah
Department of Pneumology- Havelhöhe Clinic
Outcome results
None listed