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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date April 2021
Source ResMed
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

This study aims to examine patient oxygenation levels and markers of exertion (e.g. breath rate, heart rate and breath pattern) while using a portable oxygen concentrator, with the aim to understand exercise desaturation in hypoxemic subjects.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Portable pulsed oxygen
Hypoxemic patients will use portable pulsed oxygen at rest, and while performing a six-minute walk test.

Locations

Country Name City State
Australia St George Hospital Kogarah New South Wales

Sponsors (2)

Lead Sponsor Collaborator
ResMed St George Hospital, Australia

Country where clinical trial is conducted

Australia, 

Outcome

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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