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Development of the Partial Pressure of Carbon Dioxide During Exercise and at Night in Patients With Chronic Obstructive Pulmonary Disease (COPD) IV

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01696916
First Posted: October 2, 2012
Last Update Posted: April 15, 2014
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.
Information provided by (Responsible Party):
Klaus Kenn, Klinikum Berchtesgadener Land der Schön-Kliniken
  Purpose
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").

Condition Intervention
Chronic Obstructive Pulmonary Disease Procedure: 6-minute walking test

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by Klaus Kenn, Klinikum Berchtesgadener Land der Schön-Kliniken:

Primary Outcome Measures:
  • 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 Measures:
  • Change of PaCO2 [ Time Frame: From the beginning of the 6-minute walking test until peak PaCO2, assessed up to 6 minutes ]

Enrollment: 75
Study Start Date: March 2012
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: exercise testing
6-minute walking test with pCO2 and pO2 measurement
Procedure: 6-minute walking test
submaximum exercise test

  Eligibility

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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): NCT01696916


Locations
Germany
Klinikum Berchtesgadener Land
Berchtesgaden, Germany
Sponsors and Collaborators
Klinikum Berchtesgadener Land der Schön-Kliniken
Investigators
Study Chair: Klaus Kenn, Dr. med. Klinikum Berchtesgadener Land, Schön Klinik
  More Information

Responsible Party: Klaus Kenn, Head physician (department of pneumology), Klinikum Berchtesgadener Land der Schön-Kliniken
ClinicalTrials.gov Identifier: NCT01696916     History of Changes
Other Study ID Numbers: Sentec2012
First Submitted: February 21, 2012
First Posted: October 2, 2012
Last Update Posted: April 15, 2014
Last Verified: April 2014

Keywords provided by Klaus Kenn, Klinikum Berchtesgadener Land der Schön-Kliniken:
COPD
carbon dioxide
6-minute walking test

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases