Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000150549p
Ethics application status
Submitted, not yet approved
Date submitted
18/12/2023
Date registered
16/02/2024
Date last updated
16/02/2024
Date data sharing statement initially provided
16/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Humidified flow therapy for people living in the community with chronic respiratory disease
Scientific title
Feasibility, safety and acceptability of short-term humidified flow therapy in people with respiratory conditions living in the community
Secondary ID [1] 311203 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic respiratory disease with sputum burden and/or breathlessness 332391 0
Condition category
Condition code
Respiratory 329093 329093 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
myAirvo 3TM (Fisher & Paykel) is a non-invasive respiratory support that provides flow from 2-60 L/min and delivers heated (up to 38°C) and humidified (100% relative humidity) air via a nasal cannula, with supplemental oxygen as required.
Participants will have an individualised dose of oxygen only as prescribed by their Respiratory Physician and if required.
Participants will be able to use myAirvo 3TM at home. Participants will be advised to use myAirvo 3TM for at least one hour a day for 28 days.
Registered Nurses, Respiratory Physiotherapists, Respiratory Registrars and Physicians, will administer the intervention.
Adherence to the intervention will be monitored remotely via myAirvo 3TM.
Intervention code [1] 327654 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336910 0
Feasibility of myAirvo 3 for treating people with chronic respiratory disease in the community
Timepoint [1] 336910 0
Baseline, at week 1, 2 and 3 from baseline, and at end of intervention (week 4)
Primary outcome [2] 337150 0
Safety of myAirvo 3 for treating people with chronic respiratory disease in the community
Timepoint [2] 337150 0
Baseline, at week 1, 2 and 3 from baseline, and at end of intervention (week 4)
Primary outcome [3] 337151 0
Acceptability of myAirvo 3 for treating people with chronic respiratory disease in the community
Timepoint [3] 337151 0
Baseline, at week 1, 2 and 3 from baseline, and at end of intervention (week 4)
Secondary outcome [1] 430147 0
Quality of life
Timepoint [1] 430147 0
Baseline, at week 1, 2 and 3 from baseline, and at end of intervention (week 4)
Secondary outcome [2] 430871 0
Symptom change
Timepoint [2] 430871 0
Baseline, at week 1, 2 and 3 from baseline, and at end of intervention (week 4)
Secondary outcome [3] 430872 0
Hospital admission during 28 days trial and study period
Timepoint [3] 430872 0
Baseline, at week 1, 2 and 3 from baseline, and at end of intervention (week 4)

Eligibility
Key inclusion criteria
- greater than or equal to 18 years of age
- MMSE > 24
- Has sputum burden and/or breathlessness and a diagnosed chronic respiratory condition
- Known to The Sutherland Hospital Respiratory Coordinated Care Program
- Willingness to give written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- < 18 years of age
- MMSE greater than or equal to 24
- Unable to tolerate a nasal cannula
- Patients with a history of type 2 respiratory failure
- Unable to safely set up and use the device at home
- Has not given written informed consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2024
Actual
Date of last participant enrolment
Anticipated
1/11/2025
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 25951 0
The Sutherland Hospital - Caringbah
Recruitment postcode(s) [1] 41785 0
2229 - Caringbah

Funding & Sponsors
Funding source category [1] 315463 0
Hospital
Name [1] 315463 0
The Sutherland Hospital
Country [1] 315463 0
Australia
Primary sponsor type
Hospital
Name
The Sutherland Hospital
Address
126 Kareena Rd, Miranda NSW 2228
Country
Australia
Secondary sponsor category [1] 317533 0
None
Name [1] 317533 0
Address [1] 317533 0
Country [1] 317533 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314372 0
South Eastern Sydney Local Health District HREC
Ethics committee address [1] 314372 0
Ethics committee country [1] 314372 0
Australia
Date submitted for ethics approval [1] 314372 0
15/12/2023
Approval date [1] 314372 0
Ethics approval number [1] 314372 0

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

Contacts
Principal investigator
Name 131342 0
Dr Mary Santos
Address 131342 0
The Sutherland Hospital, Southcare, 126 Kareena Rd, NSW Miranda 2228
Country 131342 0
Australia
Phone 131342 0
+61 295407547
Fax 131342 0
Email 131342 0
Mary.Santos@health.nsw.gov.au
Contact person for public queries
Name 131343 0
Mary Santos
Address 131343 0
The Sutherland Hospital, Southcare, 126 Kareena Rd, Miranda NSW 2228
Country 131343 0
Australia
Phone 131343 0
+61 295407547
Fax 131343 0
Email 131343 0
Mary.Santos@health.nsw.gov.au
Contact person for scientific queries
Name 131344 0
Mary Santos
Address 131344 0
The Sutherland Hospital, Southcare, 126 Kareena Rd, Miranda NSW 2228
Country 131344 0
Australia
Phone 131344 0
+61 295407547
Fax 131344 0
Email 131344 0
Mary.Santos@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data collected during the trial including demographics and primary and secondary outcomes.
When will data be available (start and end dates)?
Data will be available at end of study recruitment and analysis (approx Jan 2026).
No end date for data availability.
Available to whom?
Researchers investigating similar intervention
Available for what types of analyses?
Meta-analysis
How or where can data be obtained?
Data available from Principle Investigator. Email: mary.santos@health.nsw.gov.au


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.