The Effect of Home and Hospital Mask Designs on Respiratory Variables in Healthy Volunteers

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFisher and Paykel Healthcare

About this trial

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.

Eligibility criteria

Qualifiers

Aged 18 years or over

Able to give informed consent

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Non-invasive ventilation (NIV)

Treatment groups

10 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Locations

This trial has no locations

Sponsors and collaborators