Portable Oxygen Concentrator Signal Capture Study

Hypoxia Clinical Trial

Official title:

Portable Oxygen Concentrator Signal Capture Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03182036
• Other study ID #: AR110517
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Hypoxia

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