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

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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

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.

Condition or disease Intervention/treatment Phase
Pneumothorax Behavioral: Bed rest Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prevention of Pneumothorax Following Endoscopic Valve Therapy in Patients With Severe Emphysema
Study Start Date : September 2016
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Modified medical care
Patients will undergo 48-hours bed rest after endoscopic valve implantation.
Behavioral: Bed rest
Patients will undergo bed rest for 48 hours following endoscopic valve implantation.

No Intervention: Standard medical care
Patients will be treated with standard medical care without restriction to bed rest after endoscopic valve implantation.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03034421


Contacts
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Contact: Daniela Gompelmann, MD 0049-6221-3968087 daniela.gompelmann@med.uni-heidelberg.de

Locations
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Germany
Thoraxklinik Heidelberg Recruiting
Heidelberg, Germany, 69126
Contact: Daniela Gompelmann, MD    +49(0)62213968087    daniela.gompelmann@thoraxklinik-heidelberg.de   
Principal Investigator: Daniela Gompelmann, MD         
Sponsors and Collaborators
Heidelberg University
Investigators
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Principal Investigator: Daniela Gompelmann, MD Thoraxklinik at University of Heidelberg

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Responsible Party: Heidelberg University
ClinicalTrials.gov Identifier: NCT03034421     History of Changes
Other Study ID Numbers: Protocol G1.1 - 17.04.2016
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: January 27, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
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Pneumothorax
Emphysema
Pathologic Processes
Respiratory Tract Diseases
Pleural Diseases