Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03182036




Registration number
NCT03182036
Ethics application status
Date submitted
16/05/2017
Date registered
9/06/2017
Date last updated
19/04/2021

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
N/A
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
Not Applicable
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
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 website
https://clinicaltrials.gov/ct2/show/NCT03182036
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03182036