Back to resultsPortable Oxygen Concentrator Signal Capture Study
Primary Purpose
Hypoxia
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Portable pulsed oxygen
Sponsored by
About this trial
This is an interventional treatment trial for Hypoxia
Eligibility Criteria
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
Sites / Locations
- St George Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study group
Arm Description
Portable pulsed oxygen
Outcomes
Primary Outcome Measures
Oxygenation
SpO2 during rest and exercise using portable pulsed oxygen therapy
Secondary Outcome Measures
Heart rate
Heart rate during rest and exercise using portable pulsed oxygen therapy
Nasal cannula pressure
Nasal cannula pressure during rest and exercise using portable pulsed oxygen therapy
Full Information
NCT ID
NCT03182036
First Posted
May 16, 2017
Last Updated
April 14, 2021
Sponsor
ResMed
Collaborators
St George Hospital, Australia
1. Study Identification
Unique Protocol Identification Number
NCT03182036
Brief Title
Portable Oxygen Concentrator Signal Capture Study
Official Title
Portable Oxygen Concentrator Signal Capture Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
May 26, 2017 (Actual)
Primary Completion Date
August 3, 2017 (Actual)
Study Completion Date
August 3, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ResMed
Collaborators
St George Hospital, Australia
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm Description
Portable pulsed oxygen
Intervention Type
Device
Intervention Name(s)
Portable pulsed oxygen
Intervention Description
Hypoxemic patients will use portable pulsed oxygen at rest, and while performing a six-minute walk test.
Primary Outcome Measure Information:
Title
Oxygenation
Description
SpO2 during rest and exercise using portable pulsed oxygen therapy
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
Heart rate
Description
Heart rate during rest and exercise using portable pulsed oxygen therapy
Time Frame
20 minutes
Title
Nasal cannula pressure
Description
Nasal cannula pressure during rest and exercise using portable pulsed oxygen therapy
Time Frame
20 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul A Dickens, PhD
Organizational Affiliation
ResMed
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Peter Wlodarczyk, BEng
Organizational Affiliation
ResMed
Official's Role
Study Director
Facility Information:
Facility Name
St George Hospital
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Portable Oxygen Concentrator Signal Capture Study
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