Clinical Trial: The Effect of Non-invasive Ventilation on the Oxygenation of Peripheral Muscle in Hypercapnic COPD Patients

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: The Effect of Non-invasive Ventilation on the Oxygenation of Peripheral Muscle Tissue, Cardiovascular System and Exercise Capacity in Hypercapnic COPD Patients

Brief 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.

Detailed Summary:

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.

Sponsor: Klinikum Berchtesgadener Land der Schön-Kliniken

Current Primary Outcome: Tissue Saturation Index [ Time Frame: 30 minutes ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Borg scale of dyspnoea [ Time Frame: 30 minutes ]
  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
• Borg scale of leg fatigue [ Time Frame: 30 minutes ]
  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
• Oxygen saturation [ Time Frame: 30 minutes ]
  Measurement of the oxygen saturation during the constant work rate tests
• Heart rate [ Time Frame: 30 minutes ]
  Measurement of the heart rate during the constant work rate tests using a pulse oximeter
• Arterial blood pressure [ Time Frame: 30 minutes ]
  Riva-Rocci measurement of the arterial blood pressure before and in the end of the constant work rate tests
• arterial carbondioxide partial pressure [ Time Frame: 30 minutes ]
  recording of the transcutaneously measured arterial carbondioxide partial pressure using Sentec technology during the constant work rate tests
• cycle endurance time [ Time Frame: maximum 20 minutes ]
  time patient ist able to cycle at 60% of his peak work rate

Original Secondary Outcome: Same as current

Information By: Klinikum Berchtesgadener Land der Schön-Kliniken

Dates:
Date Received: August 19, 2016
Date Started: August 2016
Date Completion: July 2017
Last Updated: October 7, 2016
Last Verified: October 2016