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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03034421
Other study ID # Protocol G1.1 - 17.04.2016
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date September 2016
Est. completion date September 30, 2018

Study information

Verified date July 2022
Source Heidelberg University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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)

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Bed rest
Patients will undergo bed rest for 48 hours following endoscopic valve implantation.

Locations

Country Name City State
Germany Thoraxklinik Heidelberg Heidelberg

Sponsors (1)

Lead Sponsor Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

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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