COPDNCT02877290
The Effect of Non-invasive Ventilation on the Oxygenation of Peripheral Muscle in Hypercapnic COPD Patients
A study testing non-invasive ventilation (NIV) in people with COPD and Hypercapnia, run by Schön Klinik Berchtesgadener Land at 1 site in Germany.
Trial summary
In this study, 20 hypercapnic COPD patients will perform two constant workrate endurance cycle tests. One test will be while using non-invasive Ventilation (NIV) support, one without in a randomized cross-over design. The aim is to measure, whether NIV is able to change peripheral and respiratory muscle oxygenation. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COPD, Hypercapnia
- What is being tested?
- non-invasive ventilation (NIV)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2016to Oct 2017
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic obstructive pulmonary disease GOLD (Global initiative for chronic obstructive lung disease) stage IV
- Hypercapnia: pCO2>50mmHg (at rest or in exercise)
- written consent
Who cannot join
- orthopaedic comorbidities that do not allow a cycle endurance test
- acute exacerbation of COPD
- Cardiac insufficiency, acute coronary syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Non-invasive Ventilation on the Oxygenation of Peripheral Muscle Tissue, Cardiovascular System and Exercise Capacity in Hypercapnic COPD Patients
In this study, 20 hypercapnic COPD patients will perform two constant workrate endurance cycle tests. One test will be while using non-invasive Ventilation (NIV) support, one without in a randomized cross-over design. The aim is to measure, whether NIV is able to change peripheral and respiratory muscle oxygenation.
Read the detailed description
In this study patients will perform one incremental work rate test to obtain peak work rate. On the following days two constant work rate cycle endurance tests (CWRT) will be performed at 60% of Peak work rate using a randomised cross-over design. Between the two CWRTs there will be one hour of recovery time in between.
One of the CWRTs will be performed with the support of non-invasive Ventilation (NIV), the other one without. Respiratory and cardiovascular parameters will be observed through transcutaneous measurement of CO2 (Sentec device) and near-infrared spectroscopy devices.
The purpose of this study is, to examine whether the use of NIV not only decreases patients dyspnoea, but also has positive effects on the patients cardiovascular System, exercise capacity and muscle oxygenation. The investigators will examine the tissue oxygen saturation in the 7th intercostal space (reflecting a respiratory muscle) and on the M. vastus lateralis of the leg during both CWRTs. With the Support of NIV, it is expected to see a change in the oxygenation towards a better perfusion of the leg muscle, due to a facilitation of the work of breathing. This may result in a later onset of leg fatigue and an increased exercise capacity of the patients. To have an equivalent workload all parameters will be compared during isotime.
To conclude, aim of this study is to record the interplay of Oxygenation and Perfusion between the Intercostal muscles and the peripheral leg muscle during exercise. The investigators hypothesize, that the use of NIV may change the oxygenation in favour of the leg muscle through relieving the respiratory muscles.
- Conditions
- COPD, Hypercapnia
- Being tested
- non-invasive ventilation (NIV)
- Keywords
- COPD, NIRS, NIV, Exercise
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Hypercapnia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive ventilation (NIV)Device
| Study group | Role | What they receive |
|---|---|---|
| cycling test first with NIV, then without NIV | Experimental | patients in this arm will perform their first constant work rate test while using NIV and the second constant work rate test without NIV Receives: Device: non-invasive ventilation (NIV) |
| cycling test first without NIV, then with NIV | Experimental | patients in this arm will perform their first constant work rate test without NIV and the second constant work rate test with NIV Receives: Device: non-invasive ventilation (NIV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
cycle endurance time
time patient ist able to cycle at 60% of his peak work rate
Measured: maximum 20 minutes
Secondary outcomes (8)
Borg scale of dyspnoea
In the beginning and in the end of the constant work rate tests patients will be asked to rate their current level of dyspnoea on the modified Borg scale from 0 to 10
Measured: 30 minutes
Borg scale of leg fatigue
In the beginning and in the end of the constant work rate tests patients will be asked to rate their current Level of leg fatigue on the modified Borg scale from 0 to 10
Measured: 30 minutes
Oxygen saturation
Measurement of the oxygen saturation during the constant work rate tests
Measured: 30 minutes
Heart rate
Measurement of the heart rate during the constant work rate tests using a pulse oximeter
Measured: 30 minutes
Arterial blood pressure
Riva-Rocci measurement of the arterial blood pressure before and in the end of the constant work rate tests
Measured: 30 minutes
arterial carbondioxide partial pressure
recording of the transcutaneously measured arterial carbondioxide partial pressure using Sentec technology during the constant work rate tests
Measured: 30 minutes
Tissue Saturation Index
the near infrared technology delivers the Tissue Saturation Index throughout the constant work rate test
Measured: 30 minutes
total hemoglobin
the near infrared technology delivers the Tissue Saturation Index throughout the constant work rate test
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schön Klinik Berchtesgadener Land
- Sponsor type
- University, hospital or other
- Collaborators
- ResMed
- Responsible party
- Principal investigator, Klaus Kenn, Schön Klinik Berchtesgadener Land
- Investigators
- Klaus Kenn, Prof. Dr., Principal investigator, Schoen Klinik BGL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02877290
- Sponsor's protocol ID
- NIV/NIRS in exercise
- Status last verified
- Nov 2017
- First submitted
- 19 Aug 2016
- Last updated
- 8 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Gloeckl R, Andrianopoulos V, Stegemann A, Oversohl J, Schneeberger T, Schoenheit-Kenn U, Hitzl W, Dreher M, Koczulla AR, Kenn K. High-pressure non-invasive ventilation during exercise in COPD patients with chronic hypercapnic respiratory failure: A randomized, controlled, cross-over trial. Respirology. 2019 Mar;24(3):254-261. doi: 10.1111/resp.13399. Epub 2018 Sep 21.
PubMed 30242790
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Non-invasive Ventilation on the Oxygenation of Peripheral Muscle Tissue, Cardiovascular System and Exercise Capacity in Hypercapnic COPD Patients
- ClinicalTrials.gov ID
- NCT02877290
- Acronym / sponsor ID
- NIV/NIRS in exercise
- Conditions
- COPD, Hypercapnia
- Keywords
- COPD, NIRS, NIV, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Schön Klinik Berchtesgadener LandUniversity, hospital or other
- Collaborators
- ResMed
- Study start
- Aug 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 24 Aug 2016 (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.
In this study, 20 hypercapnic COPD patients will perform two constant workrate endurance cycle tests. One test will be while using non-invasive Ventilation (NIV) support, one without in a randomized cross-over design. The aim is to measure, whether NIV is able to change peripheral and respiratory muscle oxygenation.
Detailed description
In this study patients will perform one incremental work rate test to obtain peak work rate. On the following days two constant work rate cycle endurance tests (CWRT) will be performed at 60% of Peak work rate using a randomised cross-over design. Between the two CWRTs there will be one hour of recovery time in between.
One of the CWRTs will be performed with the support of non-invasive Ventilation (NIV), the other one without. Respiratory and cardiovascular parameters will be observed through transcutaneous measurement of CO2 (Sentec device) and near-infrared spectroscopy devices.
The purpose of this study is, to examine whether the use of NIV not only decreases patients dyspnoea, but also has positive effects on the patients cardiovascular System, exercise capacity and muscle oxygenation. The investigators will examine the tissue oxygen saturation in the 7th intercostal space (reflecting a respiratory muscle) and on the M. vastus lateralis of the leg during both CWRTs. With the Support of NIV, it is expected to see a change in the oxygenation towards a better perfusion of the leg muscle, due to a facilitation of the work of breathing. This may result in a later onset of leg fatigue and an increased exercise capacity of the patients. To have an equivalent workload all parameters will be compared during isotime.
To conclude, aim of this study is to record the interplay of Oxygenation and Perfusion between the Intercostal muscles and the peripheral leg muscle during exercise. The investigators hypothesize, that the use of NIV may change the oxygenation in favour of the leg muscle through relieving the respiratory muscles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cycling test first with NIV, then without NIV | Experimental | Device: non-invasive ventilation (NIV)patients in this arm will perform their first constant work rate test while using NIV and the second constant work rate test without NIV |
| cycling test first without NIV, then with NIV | Experimental | Device: non-invasive ventilation (NIV)patients in this arm will perform their first constant work rate test without NIV and the second constant work rate test with NIV |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic obstructive pulmonary disease GOLD (Global initiative for chronic obstructive lung disease) stage IV
- Hypercapnia: pCO2>50mmHg (at rest or in exercise)
- written consent
Key exclusion criteria (3 listed)
- orthopaedic comorbidities that do not allow a cycle endurance test
- acute exacerbation of COPD
- Cardiac insufficiency, acute coronary syndrome
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 |
|---|---|---|
| non-invasive ventilation (NIV) | Device | cycling test first with NIV, then without NIV, cycling test first without NIV, then with NIV |
Primary outcome
cycle endurance time
Time frame: maximum 20 minutes
time patient ist able to cycle at 60% of his peak work rate
8 secondary outcomes
Borg scale of dyspnoea
Time frame: 30 minutes
Borg scale of leg fatigue
Time frame: 30 minutes
Oxygen saturation
Time frame: 30 minutes
Heart rate
Time frame: 30 minutes
Arterial blood pressure
Time frame: 30 minutes
arterial carbondioxide partial pressure
Time frame: 30 minutes
Tissue Saturation Index
Time frame: 30 minutes
total hemoglobin
Time frame: 30 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 8 Nov 2017.
- Derived from this study: PubMed 30242790Gloeckl R, Andrianopoulos V, Stegemann A, Oversohl J, Schneeberger T, Schoenheit-Kenn U, Hitzl W, Dreher M, Koczulla AR, Kenn K. High-pressure non-invasive ventilation during exercise in COPD patients with chronic hypercapnic respiratory failure: A randomized, controlled, cross-over trial. Respirology. 2019 Mar;24(3):254-261. doi: 10.1111/resp.13399. Epub 2018 Sep 21.
- Individual participant dataSharing planned: No
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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, Prof. Dr. principal investigator
Schoen Klinik BGL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-invasive ventilation (NIV) in people with COPD and Hypercapnia, 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 3 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 8 Nov 2017. 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?
cycle endurance time (time frame: maximum 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02877290, which also lists 1 linked publication.
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 8 Nov 2017.