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

Primary Purpose

COPD, Hypercapnia

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
non-invasive ventilation (NIV)
Sponsored by
Schön Klinik Berchtesgadener Land
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD focused on measuring COPD, NIRS, NIV, Exercise

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Schoen Klinik BGL

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

cycling test first with NIV, then without NIV

cycling test first without NIV, then with NIV

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 19, 2016
Last Updated
November 7, 2017
Sponsor
Schön Klinik Berchtesgadener Land
Collaborators
ResMed
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1. Study Identification

Unique Protocol Identification Number
NCT02877290
Brief Title
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

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Schön Klinik Berchtesgadener Land
Collaborators
ResMed

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Hypercapnia
Keywords
COPD, NIRS, NIV, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cycling test first with NIV, then without NIV
Arm Type
Experimental
Arm Description
patients in this arm will perform their first constant work rate test while using NIV and the second constant work rate test without NIV
Arm Title
cycling test first without NIV, then with NIV
Arm Type
Experimental
Arm Description
patients in this arm will perform their first constant work rate test without NIV and the second constant work rate test with NIV
Intervention Type
Device
Intervention Name(s)
non-invasive ventilation (NIV)
Primary Outcome Measure Information:
Title
cycle endurance time
Description
time patient ist able to cycle at 60% of his peak work rate
Time Frame
maximum 20 minutes
Secondary Outcome Measure Information:
Title
Borg scale of dyspnoea
Description
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
Time Frame
30 minutes
Title
Borg scale of leg fatigue
Description
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
Time Frame
30 minutes
Title
Oxygen saturation
Description
Measurement of the oxygen saturation during the constant work rate tests
Time Frame
30 minutes
Title
Heart rate
Description
Measurement of the heart rate during the constant work rate tests using a pulse oximeter
Time Frame
30 minutes
Title
Arterial blood pressure
Description
Riva-Rocci measurement of the arterial blood pressure before and in the end of the constant work rate tests
Time Frame
30 minutes
Title
arterial carbondioxide partial pressure
Description
recording of the transcutaneously measured arterial carbondioxide partial pressure using Sentec technology during the constant work rate tests
Time Frame
30 minutes
Title
Tissue Saturation Index
Description
the near infrared technology delivers the Tissue Saturation Index throughout the constant work rate test
Time Frame
30 minutes
Title
total hemoglobin
Description
the near infrared technology delivers the Tissue Saturation Index throughout the constant work rate test
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Kenn, Prof. Dr.
Organizational Affiliation
Schoen Klinik BGL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schoen Klinik BGL
City
Schoenau Am Königssee
State/Province
Bayern
ZIP/Postal Code
83471
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30242790
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.
Results Reference
derived

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

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