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Trial registered on ANZCTR


Registration number
ACTRN12616000286448
Ethics application status
Approved
Date submitted
25/02/2016
Date registered
4/03/2016
Date last updated
11/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
AirSpiral and tracheostomy connector usability with myAIRVO 2
Scientific title
AirSpiral and tracheostomy connector usability in children and adults using myAIRVO 2
Secondary ID [1] 288573 0
None
Universal Trial Number (UTN)
U111111788883
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic obstructive pulmonary disease 297700 0
Requirement for Tracheostomy 297861 0
Bronchiectasis 297901 0
Condition category
Condition code
Respiratory 297885 297885 0 0
Chronic obstructive pulmonary disease
Respiratory 297886 297886 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will consist of two arms comprising:
1) Home-based children who have tracheotomies and require heated humidification therapy.
2) Home-based adult nasal high flow users.

In arm 1), the caregivers of children users of myAIRVO 2 will be given 2 new tracheostomy connectors and 1 new heated breathing tube. They will be asked to setup, use, and clean these new devices as they did with predicate devices for a 60 day period ( the maximum period of use for the new breathing tube). They will be asked to use the 1st tracheostomy connector for the first 30 days (the maximum duration of use for the connector) and then use 2nd for the next 30 days of the trial. At the end of the trial period, the caregivers will fill out and questionnaire to evaluate the usability of the new devices and perceived comfort. All trialled devices will be functionally and visually inspected at the end of the trial.

In arm 2), current adult users of myAIRVO 2 will be given a new heated breathing tube. They will be asked to use the new heated breathing tube in the same manner as the old breathing tube for a 60 day period (the maximum duration of use for the new tube). At the end of the use period, the participants will be asked a short questionnaire to evaluate the usability and comfort of the new breathing tube. The tested breathing tube will be collected and functionally and visually inspected at the end of the trial.
Intervention code [1] 293959 0
Treatment: Devices
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297405 0
Usability of new breathing tube and tracheostomy connector will be evaluated by the user (participant or caregiver) using a 10-point Likert Scale rating.
Timepoint [1] 297405 0
After 2 months of use
Secondary outcome [1] 320972 0
Comfort of new heated breathing tube and tracheostomy connector will be evaluated by the user (participant or caregiver) using a 10-point Likert Scale rating.
Timepoint [1] 320972 0
After 2 months of use

Eligibility
Key inclusion criteria
Arm 1: At least 6 months but less than 18 years of age, current user of myAIRVO 2, expected to require heated humidification for a tracheotomy for more than 2 months.

Arm 2: 18 years or older, current user of myAIRVO 2, expected to use myAIRVO 2 for 2 months or longer.
Minimum age
6 Months
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any condition that at the investigator discretion is believed may present a safety risk or impact the feasibility of the study or validity of the study results.

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7603 0
New Zealand
State/province [1] 7603 0
Auckland

Funding & Sponsors
Funding source category [1] 292921 0
Commercial sector/Industry
Name [1] 292921 0
Fisher & Paykel Healthcare
Address [1] 292921 0
15 Maurice Paykel Place, East Tamaki, Auckland 2013
Country [1] 292921 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fisher & Paykel Healthcare
Address
15 Maurice Paykel Place, East Tamaki, Auckland 2013
Country
New Zealand
Secondary sponsor category [1] 291677 0
None
Name [1] 291677 0
Address [1] 291677 0
Country [1] 291677 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294426 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 294426 0
Ethics committee country [1] 294426 0
New Zealand
Date submitted for ethics approval [1] 294426 0
29/01/2016
Approval date [1] 294426 0
15/03/2016
Ethics approval number [1] 294426 0
16/NTA/6

Summary
Brief summary
Nasal high flow (NHF) is an emerging treatment for providing domiciliary humidification via a nasal cannula. The NHF system can also be used to provide heated humidification to patients in the community with tracheotomies through the use of the tracheostomy connector. The purpose of this investigation is to evaluate the ease of setup, comfort, and performance of the consumables (breathing tube, patient interface) used to provide these therapies. This investigation will provide formative and summative information to help evaluate the usability of currently used devices and provide design input for future development.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63662 0
Dr James Revie
Address 63662 0
Fisher & Paykel Healthcare, 15 Maurice Paykel Place, East Tamaki, Auckland 2013
Country 63662 0
New Zealand
Phone 63662 0
+64 9 574 0123 ext 7733
Fax 63662 0
Email 63662 0
james.revie@fphcare.co.nz
Contact person for public queries
Name 63663 0
Dr James Revie
Address 63663 0
Fisher & Paykel Healthcare, 15 Maurice Paykel Place, East Tamaki, Auckland 2013
Country 63663 0
New Zealand
Phone 63663 0
+64 9 574 0123 ext 7733
Fax 63663 0
Email 63663 0
james.revie@fphcare.co.nz
Contact person for scientific queries
Name 63664 0
Dr James Revie
Address 63664 0
Fisher & Paykel Healthcare, 15 Maurice Paykel Place, East Tamaki, Auckland 2013
Country 63664 0
New Zealand
Phone 63664 0
+64 9 574 0123 ext 7733
Fax 63664 0
Email 63664 0
james.revie@fphcare.co.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary