Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Effects of Supplemental Oxygen Delivery Via Demand Versus Continuous Flow in Hypoxemic COPD Patients
NCT number | NCT02744170 |
Other study ID # | O2-Demand-Study |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2016 |
Est. completion date | October 2018 |
Verified date | January 2019 |
Source | Klinikum Berchtesgadener Land der Schön-Kliniken |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Oxygen supplementation has been proven to be effective in hypoxemic COPD patients by
increasing oxygenation and reducing dyspnea. In clinical practice there are three common
oxygen delivery systems used: continuous oxygen flow (CF), demand oxygen delivery with liquid
oxygen (DDL) and demand oxgen delivery with portable oxygen concentrator (DDC). The CF
involves considerable wastage of oxygen because oxygen is supplied during in- and exhalation.
Demand oxygen delivery saves oxygen and results in a comparable oxygen saturation at rest in
COPD patients. However, it is unknown, if oxygen supplementation via demand oxygen delivery
is also sufficient during exercise in hypoxemic COPD patients. In addition, it has to be
considered that the lower weight of demand oxygen delivery system might enable patients for
higher physical activity level and mobility in daily life.
The effects of These three oxygen delivery systems shall be investigated by a randomized,
controlled cross-over Trial. Every patient has to perform an Incremental Shuttle Walk Test
and three Endurance Shuttle Walk Tests with three different oxygen supplementation (via CF,
DDL or DDK) in randomized order.
Status | Completed |
Enrollment | 70 |
Est. completion date | October 2018 |
Est. primary completion date | October 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 75 Years |
Eligibility |
Inclusion Criteria: - COPD patients (GOLD stage III to IV) with hypoxemia at rest or during exercise (paO2<60mmHg) - Participation in an inpatient pulmonary rehabilitation program (Schön Klinik BGL) - Written informed consent Exclusion Criteria: - General exclusion criteria for exercise tests, e.g. acute coronary syndrome, acute myo- or pericarditis, acute lung embolism, pulmonary infarction, acute uncontrolled heart insufficiency - Signs of acute exacerbation - Any orthopedic or neurological disabilities that prevent patient from walking |
Country | Name | City | State |
---|---|---|---|
Germany | Klinikum Berchtesgadener Land | Schönau | Berchtesgardener Land |
Lead Sponsor | Collaborator |
---|---|
Klinikum Berchtesgadener Land der Schön-Kliniken |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Oxygen saturation at isotime of the endurance shuttle walk test (ESWT), compared between CF (liquid oxygen) and DD (liquid oxygen) | continuous transcutaneous recording during ESWT by Sentec-Digital-Monitor | at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT | |
Secondary | Breathing frequency | measured by Visionox | at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT | |
Secondary | Inspiratory capacity | measured by Spiropalm | at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT | |
Secondary | Heart rate | continuous transcutaneous recording during ESWT by Sentec-Digital-Monitor | at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT | |
Secondary | Walking distance during ESWT | total distance walked during ESWT | at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT | |
Secondary | dyspnea | assessed by modified Borg scale (0 to 10) | at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT | |
Secondary | partial pressure of carbon dioxide | continuous transcutaneous recording during ESWT by Sentec-Digital-Monitor | at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT |
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