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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03034421
Recruitment Status : Unknown
Verified January 2017 by Heidelberg University.
Recruitment status was:  Recruiting
First Posted : January 27, 2017
Last Update Posted : January 27, 2017
Sponsor:
Information provided by (Responsible Party):
Heidelberg University

Tracking Information
First Submitted Date  ICMJE September 16, 2016
First Posted Date  ICMJE January 27, 2017
Last Update Posted Date January 27, 2017
Study Start Date  ICMJE September 2016
Estimated Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2017)
Advent of pneumothorax within 90 days following valve implantation [ Time Frame: 90 days following valve implantation ]
Incidence of pneumothorax that is confirmed by radiological procedures within 90 days after implantation of valves.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2017)
  • Lung function before and after valve therapy [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 30 and 90 days following valve implantation ]
    Dyspnoe score (mMRC) will be assessed 30 and 90 days following valve implantation.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention of Pneumothorax Following Endoscopic Valve Therapy in Patients With Severe Emphysema
Official Title  ICMJE Prevention of Pneumothorax Following Endoscopic Valve Therapy in Patients With Severe Emphysema
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Pneumothorax
Intervention  ICMJE Behavioral: Bed rest
Patients will undergo bed rest for 48 hours following endoscopic valve implantation.
Study Arms  ICMJE
  • Active Comparator: Modified medical care
    Patients will undergo 48-hours bed rest after endoscopic valve implantation.
    Intervention: Behavioral: Bed rest
  • No Intervention: Standard medical care
    Patients will be treated with standard medical care without restriction to bed rest after endoscopic valve implantation.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 25, 2017)
130
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2018
Estimated Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03034421
Other Study ID Numbers  ICMJE Protocol G1.1 - 17.04.2016
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Heidelberg University
Study Sponsor  ICMJE Heidelberg University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Daniela Gompelmann, MD Thoraxklinik at University of Heidelberg
PRS Account Heidelberg University
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP