Pneumothorax Clinical Trial
Official title:
Prevention of Pneumothorax Following Endoscopic Valve Therapy in Patients With Severe Emphysema
Verified date | July 2022 |
Source | Heidelberg University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Endoscopic valve therapy is an effective therapy for patients with severe emphysema and low interlobar collateral ventilation. Although, valve therapy is a minimal-invasive treatment approach, it is associated with complications the most common of which is pneumothorax with a rate of 18-25%. Modifying post-operative medical care including bed rest for 48 hours after valve implantation may reduce the risk of post-interventional pneumothorax.
Status | Terminated |
Enrollment | 38 |
Est. completion date | September 30, 2018 |
Est. primary completion date | August 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years and older |
Eligibility | Inclusion Criteria: - FEV1 < 50%, RV>150%, TLC>100% - emphysema confirmed by computed tomography - pO2 >60 mmHg (with supplemental oxygen), pCO2 < 55 mmHg (room condition) - no significant collateral ventilation (assessed by fissure analysis and/or catheter-based measurement) - no COPD exacerbation within the past 8 weeks - daily use of < 20 mg Prednisolon - non-smoking for a minimum of 4 months prior to consent - Patient has provided written informed consent Exclusion Criteria: - BMI < 18 kg/m² - clinically relevant bronchiectasis - failed cardiac clearance: defined as myocardial infarction within last 6 weeks, decompensation of heart failure - Prior lung resection (e.g. lobectomy) |
Country | Name | City | State |
---|---|---|---|
Germany | Thoraxklinik Heidelberg | Heidelberg |
Lead Sponsor | Collaborator |
---|---|
Heidelberg University |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Advent of pneumothorax within 90 days following valve implantation | Incidence of pneumothorax that is confirmed by radiological procedures within 90 days after implantation of valves. | 90 days following valve implantation | |
Secondary | Lung function before and after valve therapy | Lung function parameters (VC [L], FEV1 [L], RV [L], TLC [L] will be assessed 30 and 90 days following valve implantation. | 30 and 90 days following valve implantation | |
Secondary | Excercise capacity before and after valve therapy | 6-minute-walk test (m) will be assessed 30 and 90 days following valve implantation. | 30 and 90 days following valve implantation | |
Secondary | Dyspnoe score before and after valve therapy | Dyspnoe score (mMRC) will be assessed 30 and 90 days following valve implantation. | 30 and 90 days following valve implantation |
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