HypoxiaNCT03182036

Portable Oxygen Concentrator Signal Capture Study

A study testing Portable pulsed oxygen in people with Hypoxia, run by ResMed at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hypoxia
What is being tested?: Portable pulsed oxygen
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteAustralia
Study dates: 26 May 2017to 3 Aug 2017
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Australia1 site

St George Hospital
Kogarah, New South Wales, 2217

Other trials in Australia

About this 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.

Read the 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.

Conditions: Hypoxia
Being tested: Portable pulsed oxygen
Medical subject headings: Hypoxia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03182036
Study group	Role	What they receive
Study group	Experimental	Portable pulsed oxygen Receives: Device: Portable pulsed oxygen

What is being measured

The primary outcome is the main question the study is designed to answer.

Oxygenation
SpO2 during rest and exercise using portable pulsed oxygen therapy
Measured: 20 minutes

Secondary outcomes (2)

Heart rate
Heart rate during rest and exercise using portable pulsed oxygen therapy
Measured: 20 minutes
Nasal cannula pressure
Nasal cannula pressure during rest and exercise using portable pulsed oxygen therapy
Measured: 20 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 May 20173 Aug 2017

First posted9 Jun 2017
Study start26 May 2017
Primary completion3 Aug 2017
Study completion3 Aug 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HypoxiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03182036
Sponsor's protocol ID: AR110517
Status last verified: Apr 2021
First submitted: 16 May 2017
Last updated: 19 Apr 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Impact of Closed PBSC Collection With Reduced Gas-Phase Oxygen Exposure on Graft Quality and Early Engraftment in Allo-HSCT
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Effect of High-flow Nasal Cannula Oxygenation on the Incidence of Hypoxemia During Painless Gastrointestinal Endoscopy in Patients at High Risk for Obstructive Sleep Apnea Syndrome in High-altitude Regions
Hypoxemia, Gastric Cancer (Diagnosis)
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Sustained Cord Circulation at Emergency Cesarean Section
Asphyxia Neonatorum, Fetal Hypoxia
Recruiting
Automated Oxygen Titration With the EMILY.AI Device in a Respiratory Intermediate Care Unit
Chronic Respiratory Failure, Acute Respiratory Failure

All Hypoxia trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Portable Oxygen Concentrator Signal Capture Study
ClinicalTrials.gov ID: NCT03182036
Acronym / sponsor ID: AR110517
Conditions: Hypoxia
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: ResMedIndustry (pharma, biotech, devices)
Collaborators: St George Hospital, Australia
Study start: 26 May 2017 (actual)
Primary completion: 3 Aug 2017 (actual)
Study completion: 3 Aug 2017 (actual)
First posted: 9 Jun 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Study group	Experimental	Device: Portable pulsed oxygenPortable pulsed oxygen

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (8 listed)

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:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Portable pulsed oxygenHypoxemic patients will use portable pulsed oxygen at rest, and while performing a six-minute walk test.	Device	Study group

Primary outcome

Oxygenation
Time frame: 20 minutes
SpO2 during rest and exercise using portable pulsed oxygen therapy

2 secondary outcomes

Heart rate
Time frame: 20 minutes
Nasal cannula pressure
Time frame: 20 minutes

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
Individual participant dataSharing planned: No

Related trials for Hypoxia

RecruitingObservational study
Predict Severe Traumatic Brain Injury
Traumatic Brain Injury
Not yet recruiting
Impact of Closed PBSC Collection With Reduced Gas-Phase Oxygen Exposure on Graft Quality and Early Engraftment in Allo-HSCT
Allogeneic Hematopoietic Stem Cell Transplantation (HSCT), Oxygen Deficiency
Not yet recruiting
Effect of High-flow Nasal Cannula Oxygenation on the Incidence of Hypoxemia During Painless Gastrointestinal Endoscopy in Patients at High Risk for Obstructive Sleep Apnea Syndrome in High-altitude Regions
Hypoxemia, Gastric Cancer (Diagnosis)
Recruiting
Sustained Cord Circulation at Emergency Cesarean Section
Asphyxia Neonatorum, Fetal Hypoxia
Recruiting
Automated Oxygen Titration With the EMILY.AI Device in a Respiratory Intermediate Care Unit
Chronic Respiratory Failure, Acute Respiratory Failure

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Paul A Dickens, PhD study director

ResMed

Peter Wlodarczyk, BEng study director

ResMed

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Portable pulsed oxygen in people with Hypoxia, run by ResMed at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oxygenation (time frame: 20 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03182036.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2021.