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

Chronic Obstructive Pulmonary Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01696916
• Other study ID #: Sentec2012
• Status: Completed
• Phase: N/A
• First received: February 21, 2012
• Last updated: April 14, 2014
• Start date: March 2012
• Est. completion date: February 2014

Study information

• Verified date: April 2014
• Source: Klinikum Berchtesgadener Land der Schön-Kliniken
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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").

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Procedure:
• 6-minute walking test
submaximum exercise test

Locations

Country	Name	City	State
Germany	Klinikum Berchtesgadener Land	Berchtesgaden

Sponsors (1)

Lead Sponsor	Collaborator
Klinikum Berchtesgadener Land der Schön-Kliniken

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase of PaCO2 more than 5mmHg		From time of starting 6-minute walking test until the time of PaCO2-increase of more than 5mmHg assessed up to 6 minutes.	Yes
Secondary	Change of PaCO2		From the beginning of the 6-minute walking test until peak PaCO2, assessed up to 6 minutes	No