Prevention of Pneumothorax Following Endoscopic Valve Therapy in Patients With Severe Emphysema

Study Overview
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Brief Summary
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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.

Detailed Description
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Patient enrolment and data acquisition is to be carried out on a prospective basis. It is planned to enrol a total of 130 patients with advanced emphysema and low collateral ventilation. Patients will be randomly assigned in a 1:1 ratio to receive modified medical care including a 48 bed rest or standard medical care following valve implantation. All patients will undergo treatment at one study centre in Heidelberg.

Official Title
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Prevention of Pneumothorax Following Endoscopic Valve Therapy in Patients With Severe Emphysema

Conditions
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Pneumothorax

Intervention / Treatment
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* Behavioral: Bed rest


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Modified medical care<br>Patients will undergo 48-hours bed rest after endoscopic valve implantation. | Behavioral: Bed rest<br>* Patients will undergo bed rest for 48 hours following endoscopic valve implantation.<br>|
| No Intervention: Standard medical care<br>Patients will be treated with standard medical care without restriction to bed rest after endoscopic valve implantation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |