NCT01696916

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").

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Mar 2012

Typical duration for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2012

Completed
9 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
7 months until next milestone

First Posted

Study publicly available on registry

October 2, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

April 15, 2014

Status Verified

April 1, 2014

Enrollment Period

1.9 years

First QC Date

February 21, 2012

Last Update Submit

April 14, 2014

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPDcarbon dioxide6-minute walking test

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (1)

  • Change of PaCO2

    From the beginning of the 6-minute walking test until peak PaCO2, assessed up to 6 minutes

Study Arms (1)

exercise testing

EXPERIMENTAL

6-minute walking test with pCO2 and pO2 measurement

Procedure: 6-minute walking test

Interventions

6-minute walking testPROCEDURE

submaximum exercise test

exercise testing

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • COPD IV with and without a respiratory insufficiency
  • maximal paCO² of 55mmHg at admission (taken at rest by blood gas analysis without LTOT)

You may not qualify if:

  • paCO² \> 55mmHg
  • non-invasive ventilation
  • acute exacerbation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum Berchtesgadener Land

Berchtesgaden, Germany

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Klaus Kenn, Dr. med.

    Klinikum Berchtesgadener Land, Schön Klinik

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head physician (department of pneumology)

Study Record Dates

First Submitted

February 21, 2012

First Posted

October 2, 2012

Study Start

March 1, 2012

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

April 15, 2014

Record last verified: 2014-04

Locations

DE(1)