Endoscopic Lung Volume Reduction Coil Treatment in Patients With Chronic Hypercapnic Respiratory Failure

December 20, 2019 updated by: Dr. Hans Klose, Universitätsklinikum Hamburg-Eppendorf
Endoscopic lung volume reduction coil treatment is a treatment option for selected patients with severe emphysema. In the advanced stages, emphysema may lead to chronic hypercapnic respiratory failure. In this observational study the safety and efficacy of endoscopic lung volume reduction coil treatment in patients with chronic hypercapnic respiratory failure is evaluated.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany
        • University Hospital Hamburg-Eppendorf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with severe emphysema and chronic hypercapnic respiratory failure, in whom endoscopic lung volume reduction coil treatment is performed

Description

Inclusion Criteria:

  • Patients with emphysema (chronic obstructive pulmonary disease with forced expired volume in one second (FEV1) < 50% predicted and residual volume (RV) ≥ 200% predicted) in whom endoscopic lung volume reduction coil treatment is performed
  • Chronic hypercapnic respiratory failure (PaCO2 ≥ 50 mmHg)
  • Informed consent

Exclusion Criteria:

  • Therapeutic anticoagulation
  • Anti-platelet therapy exceeding the use of acetylsalicylic acid
  • Severe pulmonary hypertension

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in PaCO2
Time Frame: 3 months after endoscopic lung volume reduction (ELVR)
3 months after endoscopic lung volume reduction (ELVR)

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in PaCO2
Time Frame: 6 and 12 months after ELVR
6 and 12 months after ELVR
Changes in FEV1
Time Frame: 3, 6 and 12 months after ELVR
3, 6 and 12 months after ELVR
Changes in vital capacity
Time Frame: 3, 6 and 12 months after ELVR
3, 6 and 12 months after ELVR
Changes in residual volume
Time Frame: 3, 6 and 12 months after ELVR
3, 6 and 12 months after ELVR
Changes in 6-minute walk distance
Time Frame: 3, 6 and 12 months after ELVR
3, 6 and 12 months after ELVR
Changes in quality of life (St. George's Respiratory Questionnaire, SGRQ)
Time Frame: 3, 6 and 12 months after ELVR
3, 6 and 12 months after ELVR
Changes in BMI
Time Frame: 3, 6 and 12 months after ELVR
3, 6 and 12 months after ELVR

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

November 16, 2016

First Submitted That Met QC Criteria

December 16, 2016

First Posted (Estimate)

December 19, 2016

Study Record Updates

Last Update Posted (Actual)

December 24, 2019

Last Update Submitted That Met QC Criteria

December 20, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PV-5379

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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