Pulmonary Emphysema
Conditions
Brief summary
Patients with advanced heterogeneous emphysema experience improvement in clinical outcomes in the same way following either implantation of endobronchial valves or intrabronchial valves.
Detailed description
Patient enrollment and data acquisition is to be carried out on a prospective basis. It is planned to enroll a total of 50 patients with advanced heterogeneous emphysema. After decision to undertake endoscopic lung volume reduction by valve implantation patients will be randomised to two treatment arms. 25 patients receive unilateral IBV treatment or unilateral EBV treatment in each case. All patients will undergo treatment at one study centre in Heidelberg.
Interventions
DEVICEEBV implantation
In severe cases of COPD even optimum treatment involving bronchodilatation with drugs, physical training and possibly oxygen therapy is unable to influence exercise capacity and the perception of dyspnoea to a sufficient extent. Given the assumption that the elastic recoil of the small airways can be improved by a reduction in lung volume and pulmonary function overall by more ergonomic breathing mechanics and diaphragm function, various endoscopic procedures for lung volume reduction are available. The most advanced technique is the implantation of valves. The one-way mechanism of these valves allows air to be expelled during exspiration without any influx of air during inspiration.
DEVICEIBV implantation
In severe cases of COPD even optimum treatment involving bronchodilatation with drugs, physical training and possibly oxygen therapy is unable to influence exercise capacity and the perception of dyspnoea to a sufficient extent. Given the assumption that the elastic recoil of the small airways can be improved by a reduction in lung volume and pulmonary function overall by more ergonomic breathing mechanics and diaphragm function, various endoscopic procedures for lung volume reduction are available. The most advanced technique is the implantation of valves. The one-way mechanism of these valves allows air to be expelled during exspiration without any influx of air during inspiration.
Sponsors
Heidelberg University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* pulmonary function: FEV1 \< 45 %, RV \> 150 %, TLC \> 100 % * heterogeneous emphysema
Exclusion criteria
* homogeneous emphysema * significant bronchiectasis * severe concomitant diseases * pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in pulmonary function (FEV1 and RV/TLC) | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of valve migration rate | 6 months |
| Average changes in pulmonary function (FEV1, IVC, RV, TLC, RV/TLC) | 6 months |
| Average changes in 6-minute-walk-distance | 6 months |
| Number of severe adverse events | 6 months |
Countries
Germany
Outcome results
None listed