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:
Information provided by (Responsible Party):
Klaus Kenn, Klinikum Berchtesgadener Land der Schön-Kliniken
ClinicalTrials.gov Identifier:
NCT01696916
First received: February 21, 2012
Last updated: April 14, 2014
Last verified: April 2014
  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: 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 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. ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: February 21, 2012
Last Updated: April 14, 2014
Health Authority: Germany: Ethics Commission

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

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

ClinicalTrials.gov processed this record on August 21, 2014