Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Effects of Supplemental Oxygen Delivered by a Portable Oxygen Concentrator Compared to a Liquid Oxygen Device in Hypoxemic COPD Patients at Rest
Verified date | February 2018 |
Source | Klinikum Berchtesgadener Land der Schön-Kliniken |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to investigate the effects of supplemental oxygen on blood oxygenation at rest in Patients with severe to very severe COPD comparing the portable oxygen concentrator (Activox™ 4L) to a liquid continuous oxygen device (Companion®).
Status | Completed |
Enrollment | 20 |
Est. completion date | September 15, 2017 |
Est. primary completion date | September 15, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 80 Years |
Eligibility |
Inclusion Criteria: - COPD patients with hypoxemia at rest (paO2 < 55 or 60 mmHg, according to the recent supplemental oxygen guidelines [Hadringe, M., et al., British Thoracic Society guidelines for home oxygen use in adults. Thorax, 2015. 70 Suppl 1: p. i1-43.] - Participation in an inpatient pulmonary rehabilitation program (Schön Klinik BGL) - Written informed consent Exclusion Criteria: - The Need of more than 4 Liter/min Oxygen at rest to achieve PaO2 > 55 or 60mmHg - Signs of acute exacerbation - General exclusion criteria for exercise tests, e.g. acute coronary syndrome, acute myo- or pericarditis, acute lung embolism, pulmonary infarction, acute uncontrolled heart insufficiency |
Country | Name | City | State |
---|---|---|---|
Germany | Schoen Klinik Berchtesgadener Land | Schoenau Am Koenigssee |
Lead Sponsor | Collaborator |
---|---|
Klinikum Berchtesgadener Land der Schön-Kliniken |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference between LOD and POC in Partial pressure of oxygen levels | PO2 values between LOD and POC at comparable Levels of oxygen supply (1liter/minute LOD will be compared to Level 1 of POC until 4liters/Minute LOD to Level 4 of POC) | after 10 minutes of each LOD step compared to 10 minutes of each POC step | |
Secondary | Difference between LOD and POC in Partial pressure of carbon dioxide levels | PCO2 values between LOD and POC at comparable Levels of oxygen supply (1liter/minute LOD will be compared to Level 1 of POC until 4liters/Minute LOD to Level 4 of POC) | after 10 minutes of each LOD step compared to 10 minutes of each POC step | |
Secondary | Change of partial pressure of Oxygen from one POC step to the next step | Change in PO2 values from e.g. POC step 1 to POC step 2, step 2 to 3 etc. | after 10 minutes of one POC step compared to after 10 minutes of the next POC step | |
Secondary | Change of partial pressure of carbon dioxide from one POC step to the next step | Change in PCO2 values between e.g. POC step 1 to POC step 2, step 2 to 3 etc. | after 10 minutes of one POC step compared to after 10 minutes of the next POC step |
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