NCT03182036

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2017

Completed
10 days until next milestone

Study Start

First participant enrolled

May 26, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 9, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2017

Completed
Last Updated

April 19, 2021

Status Verified

April 1, 2021

Enrollment Period

2 months

First QC Date

May 16, 2017

Last Update Submit

April 14, 2021

Conditions

Hypoxia

Outcome Measures

Primary Outcomes (1)

  • Oxygenation

    SpO2 during rest and exercise using portable pulsed oxygen therapy

    20 minutes

Secondary Outcomes (2)

  • Heart rate

    20 minutes

  • Nasal cannula pressure

    20 minutes

Study Arms (1)

Study group

EXPERIMENTAL

Portable pulsed oxygen

Device: Portable pulsed oxygen

Interventions

Portable pulsed oxygenDEVICE

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

Study group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • they do not comprehend English
  • they are unable to provide written informed consent
  • they are physically unable to comply with the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St George Hospital

Kogarah, New South Wales, 2217, Australia

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Paul A Dickens, PhD

    ResMed

    STUDY DIRECTOR

  • Peter Wlodarczyk, BEng

    ResMed

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2017

First Posted

June 9, 2017

Study Start

May 26, 2017

Primary Completion

August 3, 2017

Study Completion

August 3, 2017

Last Updated

April 19, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)