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

Not Applicable

Completed

• Conditions: COPD; Hypercapnia
• Interventions: Device: non-invasive ventilation (NIV)

• Registration Number: NCT02877290
• Lead Sponsor: Schön Klinik Berchtesgadener Land

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 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 Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-19
• Study First Submitted QC: 2016-08-19
• Study First Posted: 2016-08-24
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-07
• Last Update Posted: 2017-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Chronic obstructive pulmonary disease GOLD (Global initiative for chronic obstructive lung disease) stage IV
• Hypercapnia: pCO2>50mmHg (at rest or in exercise)
• written consent

Exclusion Criteria

• orthopaedic comorbidities that do not allow a cycle endurance test
• acute exacerbation of COPD
• Cardiac insufficiency, acute coronary syndrome

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
cycling test first without NIV, then with NIV	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
cycling test first with NIV, then without NIV	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

Primary Outcome Measures

Name	Time	Method
cycle endurance time	maximum 20 minutes	time patient ist able to cycle at 60% of his peak work rate

Secondary Outcome Measures

Name	Time	Method
Oxygen saturation	30 minutes	Measurement of the oxygen saturation during the constant work rate tests
Arterial blood pressure	30 minutes	Riva-Rocci measurement of the arterial blood pressure before and in the end of the constant work rate tests
Borg scale of dyspnoea	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
Heart rate	30 minutes	Measurement of the heart rate during the constant work rate tests using a pulse oximeter
Borg scale of leg fatigue	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
arterial carbondioxide partial pressure	30 minutes	recording of the transcutaneously measured arterial carbondioxide partial pressure using Sentec technology during the constant work rate tests
total hemoglobin	30 minutes	the near infrared technology delivers the Tissue Saturation Index throughout the constant work rate test
Tissue Saturation Index	30 minutes	the near infrared technology delivers the Tissue Saturation Index throughout the constant work rate test

Trial Locations

Locations (1)

Schoen Klinik BGL; 🇩🇪 Schoenau Am Königssee, Bayern, Germany