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
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
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 20, 2014