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

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02877290
• Other study ID #: NIV/NIRS in exercise
• Status: Completed
• Phase: N/A
• First received: August 19, 2016
• Last updated: November 7, 2017
• Start date: August 2016
• Est. completion date: October 2017

Study information

• Verified date: November 2017
• Source: Klinikum Berchtesgadener Land der Schön-Kliniken
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• COPD
• Hypercapnia

Intervention

Device:
• non-invasive ventilation (NIV)

Locations

Country	Name	City	State
Germany	Schoen Klinik BGL	Schoenau Am Königssee	Bayern

Sponsors (2)

Lead Sponsor	Collaborator
Klinikum Berchtesgadener Land der Schön-Kliniken	ResMed

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cycle endurance time	time patient ist able to cycle at 60% of his peak work rate	maximum 20 minutes
Secondary	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
Secondary	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
Secondary	Oxygen saturation	Measurement of the oxygen saturation during the constant work rate tests	30 minutes
Secondary	Heart rate	Measurement of the heart rate during the constant work rate tests using a pulse oximeter	30 minutes
Secondary	Arterial blood pressure	Riva-Rocci measurement of the arterial blood pressure before and in the end of the constant work rate tests	30 minutes
Secondary	arterial carbondioxide partial pressure	recording of the transcutaneously measured arterial carbondioxide partial pressure using Sentec technology during the constant work rate tests	30 minutes
Secondary	Tissue Saturation Index	the near infrared technology delivers the Tissue Saturation Index throughout the constant work rate test	30 minutes
Secondary	total hemoglobin	the near infrared technology delivers the Tissue Saturation Index throughout the constant work rate test	30 minutes