None listed
Conditions
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.
Interventions
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
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.
Sponsors
Fisher & Paykel Healthcare
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
6 Months to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed