Back to resultsPrevention of Pneumothorax Following Endoscopic Valve Therapy in Patients With Severe Emphysema
Primary Purpose
Pneumothorax
Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Bed rest
Sponsored by
About this trial
This is an interventional prevention trial for Pneumothorax
Eligibility Criteria
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)
Sites / Locations
- Thoraxklinik Heidelberg
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Modified medical care
Standard medical care
Arm Description
Patients will undergo 48-hours bed rest after endoscopic valve implantation.
Patients will be treated with standard medical care without restriction to bed rest after endoscopic valve implantation.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Excercise capacity before and after valve therapy
6-minute-walk test (m) will be assessed 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03034421
Brief Title
Prevention of Pneumothorax Following Endoscopic Valve Therapy in Patients With Severe Emphysema
Official Title
Prevention of Pneumothorax Following Endoscopic Valve Therapy in Patients With Severe Emphysema
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Terminated
Why Stopped
difficult patient recruitment
Study Start Date
September 2016 (undefined)
Primary Completion Date
August 30, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heidelberg University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumothorax
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Modified medical care
Arm Type
Active Comparator
Arm Description
Patients will undergo 48-hours bed rest after endoscopic valve implantation.
Arm Title
Standard medical care
Arm Type
No Intervention
Arm Description
Patients will be treated with standard medical care without restriction to bed rest after endoscopic valve implantation.
Intervention Type
Behavioral
Intervention Name(s)
Bed rest
Intervention Description
Patients will undergo bed rest for 48 hours following endoscopic valve implantation.
Primary Outcome Measure Information:
Title
Advent of pneumothorax within 90 days following valve implantation
Description
Incidence of pneumothorax that is confirmed by radiological procedures within 90 days after implantation of valves.
Time Frame
90 days following valve implantation
Secondary Outcome Measure Information:
Title
Lung function before and after valve therapy
Description
Lung function parameters (VC [L], FEV1 [L], RV [L], TLC [L] will be assessed 30 and 90 days following valve implantation.
Time Frame
30 and 90 days following valve implantation
Title
Excercise capacity before and after valve therapy
Description
6-minute-walk test (m) will be assessed 30 and 90 days following valve implantation.
Time Frame
30 and 90 days following valve implantation
Title
Dyspnoe score before and after valve therapy
Description
Dyspnoe score (mMRC) will be assessed 30 and 90 days following valve implantation.
Time Frame
30 and 90 days following valve implantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniela Gompelmann, MD
Organizational Affiliation
Thoraxklinik at University of Heidelberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thoraxklinik Heidelberg
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Prevention of Pneumothorax Following Endoscopic Valve Therapy in Patients With Severe Emphysema
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