None listed
Conditions
Brief summary
The aim of this study is to evaluate the impact and feasibility of using domiciliary humidified nasal high flow therapy as an adjunct to standard care in reducing exacerbation burden and healthcare utilisation in patients with chronic lung disease, using respiratory rate as an early physiological marker of clinical deterioration. This study is a randomised, 2-period, open-label crossover trial evaluating domiciliary humidified nasal high flow (NHF) therapy in adults with chronic lung disease (CLD) who experience recurrent exacerbations.
Interventions
Participants on the intervention arm will receive humidified nasal high flow therapy (NHF) for at least 4 hours a day (preferably overnight) in their homes for 4 weeks of intervention period prior to crossing over to their standard care.
Device specifications:
o Device: myAIRVO device by Fisher & Paykel Healthcare
o Interface: nasal cannula (sized and fitted to patient to minimise air leak and discomfort with the aim of using largest size appropriate with a clear gap around each pro
Participants on the intervention arm will receive humidified nasal high flow therapy (NHF) for at least 4 hours a day (preferably overnight) in their homes for 4 weeks of intervention period prior to crossing over to their standard care. Device specifications: o Device: myAIRVO device by Fisher & Paykel Healthcare o Interface: nasal cannula (sized and fitted to patient to minimise air leak and discomfort with the aim of using largest size appropriate with a clear gap around each prong) o Flow rate: starting at 15L/min up to 60L/min, titrated to comfort?? o Humidification: temperature set between 34 and 37 degrees Celsius and titrated for comfort o FiO2: - If not on supplemental oxygen: FiO2 ~21% (room air) - If already on supplemental oxygen: fixed FiO2 as per pre-trial oxygen prescription (not titrated) Device set up and training: o Vital detect, under mattress sensor and other study equipment / paperwork will be delivered to all participants homes at the start of trial and for those starting on intervention arm, the NHF device will also be delivered at the same time by the respiratory nurses. NHF will be delivered prior to intervention period for those starting on standard care. o Set up and education by home respiratory nurses at the time of device delivery. Approximately an hour will be allocated for this. o Education will be provided on device use and troubleshooting, cleaning and maintenance and when to seek help Throughout the trial, this respiratory rate, heart rate, peripheral oxygen saturation, symptoms and quality of life questionnaires will be monitored. Adherence can be monitored via the data uploaded to online server, but participants will not be routinely contacted to encourage adherence.
Sponsors
Flinders Medical Centre
Study design
Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• age 18 years or older, • clinically diagnosed with COPD (stable, hypoxaemic and/or hypercapnic), asthma, bronchiectasis, CPFE, ILD or other chronic respiratory disease at the investigator’s discretion, • must have had 2 or more respiratory related hospital admissions in 12 months, • managed by respiratory integrated care services (RICS), • clinically stable at the time of recruitment, • participant or carer need to be able to set up / use device following education, • must be able to provide informed consent.
Exclusion criteria
• unable to provide informed consent, • severe cognitive impairment or unstable psychiatric illness that will interfere with provision of NHF therapy, • exacerbation 1 week prior to recruitment, • contraindication to using humidified nasal flow therapy such as severe facial/nasal trauma, • already using positive airway pressure device (NIV or CPAP).
Outcome results
None listed