Portable Oxygen Concentrator Signal Capture Study

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.

Study Overview

• Status: Completed
• Conditions: Hypoxia
• Intervention / Treatment: Device: Portable pulsed oxygen

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Kogarah, New South Wales, Australia, 2217
      • St George Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group; Portable pulsed oxygen	Device: Portable pulsed oxygen; Hypoxemic patients will use portable pulsed oxygen at rest, and while performing a six-minute walk test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygenation	SpO2 during rest and exercise using portable pulsed oxygen therapy	20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	Heart rate during rest and exercise using portable pulsed oxygen therapy	20 minutes
Nasal cannula pressure	Nasal cannula pressure during rest and exercise using portable pulsed oxygen therapy	20 minutes

Collaborators and Investigators

• Sponsor: ResMed
• Collaborators: St George Hospital, Australia
• Investigators: Study Director: Paul A Dickens, PhD, ResMed; Study Director: Peter Wlodarczyk, BEng, ResMed

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2017
• Primary Completion (Actual): August 3, 2017
• Study Completion (Actual): August 3, 2017

Study Registration Dates

• First Submitted: May 16, 2017
• First Submitted That Met QC Criteria: June 7, 2017
• First Posted (Actual): June 9, 2017

Study Record Updates

• Last Update Posted (Actual): April 19, 2021
• Last Update Submitted That Met QC Criteria: April 14, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: AR110517

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes