Portable Oxygen Concentrator Signal Capture Study

NCT ID: NCT03182036

Last Updated: 2021-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-26

Study Completion Date

2017-08-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Hypoxia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Study group

Portable pulsed oxygen

Group Type EXPERIMENTAL

Portable pulsed oxygen

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Portable pulsed oxygen

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

St George Hospital, Australia

OTHER

Sponsor Role collaborator

ResMed

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Paul A Dickens, PhD

Role: STUDY_DIRECTOR

ResMed

Peter Wlodarczyk, BEng

Role: STUDY_DIRECTOR

ResMed

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

St George Hospital

Kogarah, New South Wales, Australia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Australia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AR110517

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pulse Oximeter Motion Study
NCT03156140 COMPLETED NA
Pulse Oximeter Hypoxia
NCT04562584 COMPLETED NA