Hypoxia Clinical Trial
Official title:
Portable Oxygen Concentrator Signal Capture Study
NCT number | NCT03182036 |
Other study ID # | AR110517 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 26, 2017 |
Est. completion date | August 3, 2017 |
Verified date | April 2021 |
Source | ResMed |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The main purpose of this study is to learn how patients breathe on portable oxygen concentrators (POCs), and to get feedback from patients using POCs.
Status | Completed |
Enrollment | 20 |
Est. completion date | August 3, 2017 |
Est. primary completion date | August 3, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patient is willing to give written informed consent - Patient can read and comprehend English - Patient is = 18 years of age - Patient has moderate to severe hypoxaemia (SpO2 = 92%) at rest - Patient reports shortness of breath on exertion Exclusion Criteria: - Patient has musculoskeletal impairment, or other impairment that may be the limiting factor in 6MWT - Patient has a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study - Patient has acute coronary syndrome, acute myo- or pericarditis, acute lung embolism, pulmonary infarction, acute uncontrolled heart insufficiency - Patient shows signs of acute exacerbation of underlying lung condition - Patient is deemed to be unsuitable for inclusion in the opinion of the researcher, including for the following reasons: - they do not comprehend English - they are unable to provide written informed consent - they are physically unable to comply with the protocol |
Country | Name | City | State |
---|---|---|---|
Australia | St George Hospital | Kogarah | New South Wales |
Lead Sponsor | Collaborator |
---|---|
ResMed | St George Hospital, Australia |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Oxygenation | SpO2 during rest and exercise using portable pulsed oxygen therapy | 20 minutes | |
Secondary | Heart rate | Heart rate during rest and exercise using portable pulsed oxygen therapy | 20 minutes | |
Secondary | Nasal cannula pressure | Nasal cannula pressure during rest and exercise using portable pulsed oxygen therapy | 20 minutes |
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