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NCT Number: NCT02877290

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

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.

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Key information

Conditions

COPD Behavior Chronic Disease Disease Attributes Hypercapnia Lung Diseases Lung Diseases, Obstructive Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Schoen Klinik BGL

Schoenau Am Königssee, Bavaria, 83471, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-invasive ventilation (NIV)

Device

Primary outcomes

  1. cycle endurance time

    Time frame: maximum 20 minutes

    time patient ist able to cycle at 60% of his peak work rate

Secondary outcomes

  1. 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

  2. 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

  3. Oxygen saturation

    Time frame: 30 minutes

    Measurement of the oxygen saturation during the constant work rate tests

  4. Heart rate

    Time frame: 30 minutes

    Measurement of the heart rate during the constant work rate tests using a pulse oximeter

  5. 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

  6. 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

  7. Tissue Saturation Index

    Time frame: 30 minutes

    the near infrared technology delivers the Tissue Saturation Index throughout the constant work rate test

  8. total hemoglobin

    Time frame: 30 minutes

    the near infrared technology delivers the Tissue Saturation Index throughout the constant work rate test

Sponsors and collaborators

Lead sponsor

Schön Klinik Berchtesgadener Land

Other

Collaborators

  • ResMed

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 24, 2016
Registry last updated
Nov 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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