None listed
Conditions
Brief summary
This is a single-centre, non-randomised, interventional study of 12 healthy, adult participants with continuous measurement of nasopharyngeal temperature during delivery of 100% humidified air via a rhinothermy device at 41°C and 35L/min (rNHF), and 31°C and 10L/min (‘sham’ rhinothermy).
Interventions
Participants will be assigned to either nasal high flow rhinothermy (rNHF) or 'sham' rhinothermy in a fixed order.
Nasal high flow rhinothermy (rNHF) at 41°C involves the delivery of 100% humidified air, heated to 41°C at 35L/min via the rhinothermy device produced by Fisher & Paykel Healthcare.
The rNHF rhinothermy device is a humidifier with integrated flow generator. It draws in room air which is humidified and heated to a set dew point by the device.
Participants will receive their inte
Participants will be assigned to either nasal high flow rhinothermy (rNHF) or 'sham' rhinothermy in a fixed order. Nasal high flow rhinothermy (rNHF) at 41°C involves the delivery of 100% humidified air, heated to 41°C at 35L/min via the rhinothermy device produced by Fisher & Paykel Healthcare. The rNHF rhinothermy device is a humidifier with integrated flow generator. It draws in room air which is humidified and heated to a set dew point by the device. Participants will receive their intervention on site either on the same day as the screening visit, or at another arranged appointment. The intervention will be set-up and delivered under supervision of study investigators. Safety checks will be completed by a study investigator on each device before they are provided for use. Following the five minute baseline monitoring period, the participant will receive their intervention. During the intervention delivery, nasopharyngeal temperatures will be measured for a minimum of ten minutes each in the following order, whilst: 1. Breathing “normally” 2. Nose breathing 3. Mouth breathing Each ten minute period includes a minimum of five minutes “run-in” and five minutes “recording”. The nasopharyngeal temperature measured over five minutes during the “recording” period, are the readings that will be included in the results analysis. Breathing “normally” will be defined as a period when the participant can choose to breathe through their mouth or nose at any time as they choose, and allows talking.
Sponsors
Fisher and Paykel Healthcare Limited
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
• Aged 18-75 years inclusive • In the Investigator’s opinion, is able and willing to comply with all trial requirements
Exclusion criteria
• Any respiratory condition including but not limited to asthma, COPD, bronchiectasis and pulmonary fibrosis • Nasopharyngeal conditions such as a deviated septum and chronic rhinitis, which the investigator considers could impair nasal breathing • Current use of or requirement of oral antibiotics for a respiratory tract infection, pneumonia or infective exacerbation of an underlying respiratory condition • Current use of or requirement of parenteral antibiotics • A notifiable disease e.g. Tuberculosis or Human Immunodeficiency Virus • Current use of anticoagulant medication • Previous sinus surgery • An episode of epistaxis during the last week • Pre-existing bleeding disorder • Neurological or neuromuscular conditions which could cause disorders of breathing, swallowing or posture • Previous allergic reaction to local anaesthetic • Have any other condition which, at the investigator’s discretion, is believed may present a safety risk to the participant or others, or impact the study results or the feasibility of the study.
Outcome results
None listed