Emphysema
Conditions
Brief summary
Endoscopic lung volume reduction coil treatment is a treatment option for selected patients with severe emphysema. In the advanced stages, emphysema may lead to chronic hypercapnic respiratory failure. In this observational study the safety and efficacy of endoscopic lung volume reduction coil treatment in patients with chronic hypercapnic respiratory failure is evaluated.
Interventions
PROCEDUREEndoscopic lung volume reduction coil treatment
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with emphysema (chronic obstructive pulmonary disease with forced expired volume in one second (FEV1) \< 50% predicted and residual volume (RV) ≥ 200% predicted) in whom endoscopic lung volume reduction coil treatment is performed * Chronic hypercapnic respiratory failure (PaCO2 ≥ 50 mmHg) * Informed consent
Exclusion criteria
* Therapeutic anticoagulation * Anti-platelet therapy exceeding the use of acetylsalicylic acid * Severe pulmonary hypertension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in PaCO2 | 3 months after endoscopic lung volume reduction (ELVR) |
Secondary
| Measure | Time frame |
|---|---|
| Changes in FEV1 | 3, 6 and 12 months after ELVR |
| Changes in vital capacity | 3, 6 and 12 months after ELVR |
| Changes in residual volume | 3, 6 and 12 months after ELVR |
| Changes in PaCO2 | 6 and 12 months after ELVR |
| Changes in quality of life (St. George's Respiratory Questionnaire, SGRQ) | 3, 6 and 12 months after ELVR |
| Changes in BMI | 3, 6 and 12 months after ELVR |
| Changes in 6-minute walk distance | 3, 6 and 12 months after ELVR |
Countries
Germany
Outcome results
None listed