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Completed

NCT Number: NCT03182036

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St George Hospital

Kogarah, New South Wales, 2217, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Portable pulsed oxygen

Device

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

Primary outcomes

  1. Oxygenation

    Time frame: 20 minutes

    SpO2 during rest and exercise using portable pulsed oxygen therapy

Secondary outcomes

  1. Heart rate

    Time frame: 20 minutes

    Heart rate during rest and exercise using portable pulsed oxygen therapy

  2. Nasal cannula pressure

    Time frame: 20 minutes

    Nasal cannula pressure during rest and exercise using portable pulsed oxygen therapy

Sponsors and collaborators

Lead sponsor

ResMed

Industry

Collaborators

  • St George Hospital, Australia

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 9, 2017
Registry last updated
Apr 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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