Chronic Obstructive Pulmonary DiseaseNCT01696916
Development of the Partial Pressure of Carbon Dioxide During Exercise and at Night in Patients With Chronic Obstructive Pulmonary Disease (COPD) IV
A study testing 6-minute walking test in people with Chronic Obstructive Pulmonary Disease, run by Schön Klinik Berchtesgadener Land at 1 site in Germany.
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). Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- 6-minute walking test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2012to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD IV with and without a respiratory insufficiency
- maximal paCO² of 55mmHg at admission (taken at rest by blood gas analysis without LTOT)
Who cannot join
- paCO² > 55mmHg
- non-invasive ventilation
- acute exacerbation
Trial locations and contacts
1 site in 1 country.
About this study
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
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").
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- 6-minute walking test
- Keywords
- COPD, carbon dioxide, 6-minute walking test
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6-minute walking testProcedure or surgery
submaximum exercise test
| Study group | Role | What they receive |
|---|---|---|
| exercise testing | Experimental | 6-minute walking test with pCO2 and pO2 measurement Receives: Procedure: 6-minute walking test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase of PaCO2 more than 5mmHg
Measured: 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
Measured: From the beginning of the 6-minute walking test until peak PaCO2, assessed up to 6 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2012 (estimated)
- Study startMar 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schön Klinik Berchtesgadener Land
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klaus Kenn, Schön Klinik Berchtesgadener Land
- Investigators
- Klaus Kenn, Dr. med., Study chair, Klinikum Berchtesgadener Land, Schön Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01696916
- Sponsor's protocol ID
- Sentec2012
- Status last verified
- Apr 2014
- First submitted
- 21 Feb 2012
- Last updated
- 15 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01696916
- Acronym / sponsor ID
- Sentec2012
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, carbon dioxide, 6-minute walking test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Schön Klinik Berchtesgadener LandUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 2 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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").
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| exercise testing | Experimental | Procedure: 6-minute walking test6-minute walking test with pCO2 and pO2 measurement |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- COPD IV with and without a respiratory insufficiency
- maximal paCO² of 55mmHg at admission (taken at rest by blood gas analysis without LTOT)
Key exclusion criteria (3 listed)
- paCO² > 55mmHg
- non-invasive ventilation
- acute exacerbation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 6-minute walking testsubmaximum exercise test | Procedure or surgery | exercise testing |
Primary outcome
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.
1 secondary outcome
Change of PaCO2
Time frame: From the beginning of the 6-minute walking test until peak PaCO2, assessed up to 6 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klaus Kenn, Dr. med. study chair
Klinikum Berchtesgadener Land, Schön Klinik
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6-minute walking test in people with Chronic Obstructive Pulmonary Disease, run by Schön Klinik Berchtesgadener Land at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2014.