The goal of this randomized cross-over study is to investigate whether the design of non-invasive ventilation (NIV) mask impacts respiratory variables in healthy volunteers on NIV therapy. The main questions it aims to answer are:
* To assess if mask design impacts the ventilatory ratio in healthy volunteers. * To assess if mask design impacts transcutaneous CO2, respiratory rate, and tidal volume in healthy volunteers.
Participants will attend five study visits:
* Visit 1. Participants will be fitted to use non-invasive ventilation briefly to acclimatize them to using the therapy. * Visit 2. Participants will receive NIV with one of four masks. They will be asked to breathe through their mouth or through their nose, with a break from NIV in between the two sessions of NIV. * Visits 3-5. Participants will receive NIV with one of the other three masks, repeating Visit 2.
Aged 18 years or over
Able to give informed consent
Unable to tolerate non-invasive ventilation (NIV)
Unable to adequately fit an NIV mask
Claustrophobia while using NIV
Symptoms of cold or flu (including COVID-19) in previous twenty-four hours
Crossover
Non-invasive ventilation (NIV)
DeviceDelivery of positive airway pressure to the lungs via an interface, such as a mask
8
Treatment groupsSee each treatment group below.
Change in ventilatory ratio
To assess if mask design can reduce ventilatory ration in healthy volunteers
Change in transcutaneous carbon dioxide (CO2)
To assess if mask design can reduce transcutaneous CO2 in healthy volunteers
Change in respiratory rate
To assess if mask design can reduce respiratory rate in healthy volunteers
Change in tidal volume
To assess if mask design can reduce tidal volume in healthy volunteers
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This trial is not recruiting at the moment. You can still explore other options:
