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

The Effect of Non-invasive Ventilation on the Oxygenation of Peripheral Muscle Tissue, Cardiovascular System and Exercise Capacity 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.

Study Overview

• Status: Completed
• Conditions: COPD; Hypercapnia
• Intervention / Treatment: Device: non-invasive ventilation (NIV)

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bayern
    • Schoenau Am Königssee, Bayern, Germany, 83471
      • Schoen Klinik BGL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: non-invasive ventilation (NIV)
Experimental: 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	Device: non-invasive ventilation (NIV)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cycle endurance time	time patient ist able to cycle at 60% of his peak work rate	maximum 20 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Schön Klinik Berchtesgadener Land
• Collaborators: ResMed
• Investigators: Principal Investigator: Klaus Kenn, Prof. Dr., Schoen Klinik BGL

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: August 19, 2016
• First Submitted That Met QC Criteria: August 19, 2016
• First Posted (Estimate): August 24, 2016

Study Record Updates

• Last Update Posted (Actual): November 8, 2017
• Last Update Submitted That Met QC Criteria: November 7, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Exercise; COPD; NIV; NIRS
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypercapnia
• Other Study ID Numbers: NIV/NIRS in exercise

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No