An interventional study of non-invasive ventilation (NIV) in COPD and Hypercapnia, sponsored by Schön Klinik Berchtesgadener Land. Completed at 1 site in Germany. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-11-08.
Sponsored by Schön Klinik Berchtesgadener Land · Not applicable, Interventional, and Treatment
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.
186 studies on the registry are indexed under Hypercapnia; 34 are open to participants now.
This study's enrollment of 20 is below the median of 49 across 140 interventional studies indexed under Hypercapnia.
Browse Hypercapnia studies →Schön Klinik Berchtesgadener Land is the lead sponsor of 51 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
patients in this arm will perform their first constant work rate test while using NIV and the second constant work rate test without NIV
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
Device: non-invasive ventilation (NIV)
cycle endurance time
time patient ist able to cycle at 60% of his peak work rate
Time frame: maximum 20 minutes
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
Time frame: 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
Time frame: 30 minutes
Oxygen saturation
Measurement of the oxygen saturation during the constant work rate tests
Time frame: 30 minutes
Heart rate
Measurement of the heart rate during the constant work rate tests using a pulse oximeter
Time frame: 30 minutes
Arterial blood pressure
Riva-Rocci measurement of the arterial blood pressure before and in the end of the constant work rate tests
Time frame: 30 minutes
arterial carbondioxide partial pressure
recording of the transcutaneously measured arterial carbondioxide partial pressure using Sentec technology during the constant work rate tests
Time frame: 30 minutes
Tissue Saturation Index
the near infrared technology delivers the Tissue Saturation Index throughout the constant work rate test
Time frame: 30 minutes
total hemoglobin
the near infrared technology delivers the Tissue Saturation Index throughout the constant work rate test
Time frame: 30 minutes
Plan to share: No
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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