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

NCT ID: NCT02877290

Last Updated: 2017-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2017-10-31

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.

Conditions

COPD; Hypercapnia

Keywords

COPD; NIRS; NIV; Exercise

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

cycling test first with NIV, then without 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

Group Type: EXPERIMENTAL

non-invasive ventilation (NIV)

Intervention Type: DEVICE

cycling test first without NIV, then with NIV

patients in this arm will perform their first constant work rate test without NIV and the second constant work rate test with NIV

Group Type: EXPERIMENTAL

non-invasive ventilation (NIV)

Intervention Type: DEVICE

Interventions

non-invasive ventilation (NIV)

Intervention Type: DEVICE

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ResMed

INDUSTRY

Sponsor Role: collaborator

Schön Klinik Berchtesgadener Land

OTHER

Sponsor Role: lead

Responsible Party

Klaus Kenn

Prof. Dr. Klaus Kenn

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Klaus Kenn, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Schoen Klinik BGL

Locations

Schoen Klinik BGL

Schoenau Am Königssee, Bavaria, Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 30242790 (View on PubMed)

Other Identifiers

NIV/NIRS in exercise

Identifier Type: -

Identifier Source: org_study_id