A randomised, cross over, non-inferiority trial comparing a newly engineered non-invasive ventilator to a commercially available device in patients with respiratory failure

The total study time will be approximately 2 hours duration with all study procedures being performed by a study investigator. At the beginning of the trial a Sentec transcutaneous monitoring device sensor will be attached to the participant's earlobe to monitor transcutaneous carbon dioxide (PtCO2) and oxygen saturations (SpO2). Blood pressure monitoring will also be attached. Participants will rest for 15 minutes while the Sentec signal stabilises. If supplementary oxygen is required, it will be provided through the oxygen device in use prior to the study, or through a device agreed upon between the study investigator and the participants clinical team (examples include nasal canula, hudson mask and nasal high flow oxygen). The fraction of inspired oxygen (FiO2) will be titrated so that the participants' SpO2 values are within the target range of 88-92%. The FiO2 settings will remain fixed for the remainder of the trial. The study intervention is the Airvo-3 NIV device and the study control is the Respironics V60 NIV device. Participants will be randomised to which device they receive NIV therapy through first, and then will cross over to the other device. The first treatment period is 30 minutes of bi-level spontaneous timed non-invasive ventilation (NIV) therapy using either the intervention device or control device. A study investigator will establish the appropriate bi-level NIV settings with input from a respiratory/sleep specialist and upon review of previous therapeutic settings. If supplemental oxygen is required, it will be delivered through a port on the side of the NIV mask circuit, with the FiO2 set as the same as the FiO2 used during the initial 15 minute stabalisation period described above. The NIV mask will then be fitted by a study investigator, who will remain present to assess mask fit, intervention efficacy and adherence to the study procedures for the duration of this period. Following the first treatment period, there will be a 30 minute washout period where the participant will receive oxygen if required, using the same oxygen delivery device and FiO2 as that used during the initial 15 minute stabilization period. The participant will remain resting throughout this period. The second treatment period is 30 minutes of bi-level spontaneous timed non-invasive ventilation (NIV) therapy using whichever device was not used during the first treatment period. A study investigator will establish the appropriate bi-level NIV settings with input from a respiratory/sleep specialist and upon review of previous therapeutic settings. If supplemental oxygen is required, it will be delivered through a port on the side of the NIV mask circuit, with the FiO2 set as the same as the FiO2 used during the initial 15minute stabalisation period described above. The NIV mask will then be fitted by a study investigator, who will remain present to assess mask fit, intervention efficacy and adherence to the study procedures for the duration of this period. After completing the second treatment period, participants will be changed back onto their standard oxygen delivery device with the settings as they were prior to entering the trial. The participants involvement in the trial will then be complete.