Development of the Partial Pressure of Carbon Dioxide During Exercise and at Night in Patients With Chronic Obstructive Pulmonary Disease (COPD) IV
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
6-minute walking test
Sponsored by
About this trial
This is an interventional basic science trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, carbon dioxide, 6-minute walking test
Eligibility Criteria
Inclusion Criteria:
- COPD IV with and without a respiratory insufficiency
- maximal paCO² of 55mmHg at admission (taken at rest by blood gas analysis without LTOT)
Exclusion Criteria:
- paCO² > 55mmHg
- non-invasive ventilation
- acute exacerbation
Sites / Locations
- Klinikum Berchtesgadener Land
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
exercise testing
Arm Description
6-minute walking test with pCO2 and pO2 measurement
Outcomes
Primary Outcome Measures
Increase of PaCO2 more than 5mmHg
Secondary Outcome Measures
Change of PaCO2
Full Information
NCT ID
NCT01696916
First Posted
February 21, 2012
Last Updated
April 14, 2014
Sponsor
Schön Klinik Berchtesgadener Land
1. Study Identification
Unique Protocol Identification Number
NCT01696916
Brief Title
Development of the Partial Pressure of Carbon Dioxide During Exercise and at Night in Patients With Chronic Obstructive Pulmonary Disease (COPD) IV
Official Title
Development of the Partial Pressure of Carbon Dioxide During 6-min Walking Test and at Night in Patients With Chronic Obstructive Pulmonary Disease IV
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Schön Klinik Berchtesgadener Land
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to investigate the development of partial pressure of carbon dioxide during the 6-min walking test and during night in Chronic Obstructive Pulmonary Disease (COPD)-patients (GOLD stage IV). Therefore the partial pressure of carbon dioxide, oxygen saturation and the heart rate are registered by a device called "Sentec" during the mentioned periods. In addition a measurement of activity is realised by an activity monitor ("Sensewear").
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, carbon dioxide, 6-minute walking test
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
exercise testing
Arm Type
Experimental
Arm Description
6-minute walking test with pCO2 and pO2 measurement
Intervention Type
Procedure
Intervention Name(s)
6-minute walking test
Intervention Description
submaximum exercise test
Primary Outcome Measure Information:
Title
Increase of PaCO2 more than 5mmHg
Time Frame
From time of starting 6-minute walking test until the time of PaCO2-increase of more than 5mmHg assessed up to 6 minutes.
Secondary Outcome Measure Information:
Title
Change of PaCO2
Time Frame
From the beginning of the 6-minute walking test until peak PaCO2, assessed up to 6 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
COPD IV with and without a respiratory insufficiency
maximal paCO² of 55mmHg at admission (taken at rest by blood gas analysis without LTOT)
Exclusion Criteria:
paCO² > 55mmHg
non-invasive ventilation
acute exacerbation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Kenn, Dr. med.
Organizational Affiliation
Klinikum Berchtesgadener Land, Schön Klinik
Official's Role
Study Chair
Facility Information:
Facility Name
Klinikum Berchtesgadener Land
City
Berchtesgaden
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Development of the Partial Pressure of Carbon Dioxide During Exercise and at Night in Patients With Chronic Obstructive Pulmonary Disease (COPD) IV
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