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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03182036




Registration number
NCT03182036
Ethics application status
Date submitted
16/05/2017
Date registered
9/06/2017

Titles & IDs
Public title
Portable Oxygen Concentrator Signal Capture Study
Scientific title
Portable Oxygen Concentrator Signal Capture Study
Secondary ID [1] 0 0
AR110517
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypoxia 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Portable pulsed oxygen

Experimental: Study group - Portable pulsed oxygen


Treatment: Devices: Portable pulsed oxygen
Hypoxemic patients will use portable pulsed oxygen at rest, and while performing a six-minute walk test.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Oxygenation
Timepoint [1] 0 0
20 minutes
Secondary outcome [1] 0 0
Heart rate
Timepoint [1] 0 0
20 minutes
Secondary outcome [2] 0 0
Nasal cannula pressure
Timepoint [2] 0 0
20 minutes

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/05/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/08/2017
Sample size
Target
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
St George Hospital - Kogarah
Recruitment postcode(s) [1] 0 0
2217 - Kogarah

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ResMed
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
St George Hospital, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul A Dickens, PhD
Address 0 0
ResMed
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03182036