The Effect of Non-invasive Ventilation on the Oxygenation of Peripheral Muscle in Hypercapnic COPD Patients
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2016
CompletedFirst Submitted
Initial submission to the registry
August 19, 2016
CompletedFirst Posted
Study publicly available on registry
August 24, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedNovember 8, 2017
November 1, 2017
1.2 years
August 19, 2016
November 7, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
cycle endurance time
time patient ist able to cycle at 60% of his peak work rate
maximum 20 minutes
Secondary Outcomes (8)
Borg scale of dyspnoea
30 minutes
Borg scale of leg fatigue
30 minutes
Oxygen saturation
30 minutes
Heart rate
30 minutes
Arterial blood pressure
30 minutes
- +3 more secondary outcomes
Study Arms (2)
cycling test first with NIV, then without NIV
EXPERIMENTALpatients in this arm will perform their first constant work rate test while using NIV and the second constant work rate test without NIV
cycling test first without NIV, then with NIV
EXPERIMENTALpatients in this arm will perform their first constant work rate test without NIV and the second constant work rate test with NIV
Interventions
Eligibility Criteria
You may qualify if:
- Chronic obstructive pulmonary disease GOLD (Global initiative for chronic obstructive lung disease) stage IV
- Hypercapnia: pCO2\>50mmHg (at rest or in exercise)
- written consent
You may not qualify if:
- orthopaedic comorbidities that do not allow a cycle endurance test
- acute exacerbation of COPD
- Cardiac insufficiency, acute coronary syndrome
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Schön Klinik Berchtesgadener Landlead
- ResMedcollaborator
Study Sites (1)
Schoen Klinik BGL
Schoenau Am Königssee, Bavaria, 83471, Germany
Related Publications (1)
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.
PMID: 30242790DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Klaus Kenn, Prof. Dr.
Schoen Klinik BGL
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. Klaus Kenn
Study Record Dates
First Submitted
August 19, 2016
First Posted
August 24, 2016
Study Start
August 1, 2016
Primary Completion
October 1, 2017
Study Completion
October 1, 2017
Last Updated
November 8, 2017
Record last verified: 2017-11
Data Sharing
- IPD Sharing
- Will not share