Clinical trial NCT02877290: The Effect of Non-invasive Ventilation on the Oxygenation of Peripheral Muscle in Hypercapnic COPD Patients
Official title: The Effect of Non-invasive Ventilation on the Oxygenation of Peripheral Muscle Tissue, Cardiovascular System and Exercise Capacity in Hypercapnic COPD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Hypercapnia
Keywords: COPD
NIRS
NIV
Exercise
Lead sponsor: Schön Klinik Berchtesgadener Land
Sponsor class: OTHER
Collaborators: name: ResMed
First posted: 2016-08-24
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: cycle endurance time
timeFrame: maximum 20 minutes
Secondary outcomes:
measure: Borg scale of dyspnoea
timeFrame: 30 minutes
measure: Borg scale of leg fatigue
timeFrame: 30 minutes
measure: Oxygen saturation
timeFrame: 30 minutes
measure: Heart rate
timeFrame: 30 minutes
measure: Arterial blood pressure
timeFrame: 30 minutes
measure: arterial carbondioxide partial pressure
timeFrame: 30 minutes
measure: Tissue Saturation Index
timeFrame: 30 minutes
measure: total hemoglobin
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Schoenau Am Königssee
country: Germany
facility: Schoen Klinik BGL
state: Bayern
Study officials:
affiliation: Schoen Klinik BGL
name: Klaus Kenn, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.