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| Name | Class |
|---|---|
| ResMed | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| non-invasive ventilation (NIV) | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| cycle endurance time | time patient ist able to cycle at 60% of his peak work rate | maximum 20 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 30 minutes |
| Borg scale of leg fatigue |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Klaus Kenn, Prof. Dr. | Schoen Klinik BGL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schoen Klinik BGL | Schoenau Am Königssee | Bavaria | 83471 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30242790 | Derived | 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. |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D006935 | Hypercapnia |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D063087 | Noninvasive Ventilation |
| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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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
| 30 minutes |
| Oxygen saturation | Measurement of the oxygen saturation during the constant work rate tests | 30 minutes |
| Heart rate | Measurement of the heart rate during the constant work rate tests using a pulse oximeter | 30 minutes |
| Arterial blood pressure | Riva-Rocci measurement of the arterial blood pressure before and in the end of the constant work rate tests | 30 minutes |
| arterial carbondioxide partial pressure | recording of the transcutaneously measured arterial carbondioxide partial pressure using Sentec technology during the constant work rate tests | 30 minutes |
| Tissue Saturation Index | the near infrared technology delivers the Tissue Saturation Index throughout the constant work rate test | 30 minutes |
| total hemoglobin | the near infrared technology delivers the Tissue Saturation Index throughout the constant work rate test | 30 minutes |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D001519 | Behavior |