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

Not Applicable

Terminated

• Conditions: Pneumothorax
• Interventions: Behavioral: Bed rest

• Registration Number: NCT03034421
• Lead Sponsor: Heidelberg University

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-16
• Study First Submitted QC: 2017-01-25
• Study First Posted: 2017-01-27
• Primary Completion: 2018-08-30
• Study Completion: 2018-09-30
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-04
• Last Update Posted: 2022-07-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 38

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Modified medical care	Bed rest	Patients will undergo 48-hours bed rest after endoscopic valve implantation.

Primary Outcome Measures

Name	Time	Method
Advent of pneumothorax within 90 days following valve implantation	90 days following valve implantation	Incidence of pneumothorax that is confirmed by radiological procedures within 90 days after implantation of valves.

Secondary Outcome Measures

Name	Time	Method
Lung function before and after valve therapy	30 and 90 days following valve implantation	Lung function parameters (VC \[L\], FEV1 \[L\], RV \[L\], TLC \[L\] will be assessed 30 and 90 days following valve implantation.
Excercise capacity before and after valve therapy	30 and 90 days following valve implantation	6-minute-walk test (m) will be assessed 30 and 90 days following valve implantation.
Dyspnoe score before and after valve therapy	30 and 90 days following valve implantation	Dyspnoe score (mMRC) will be assessed 30 and 90 days following valve implantation.

Trial Locations

Locations (1)

Thoraxklinik Heidelberg; 🇩🇪 Heidelberg, Germany