Usability and Performance of a Dual Limb Mask for Non-invasive Ventilation

This is a prospective, non-randomized, non-blinded, crossover pilot investigation to assess the usability, and performance of the investigational OptiNIV Dual mask in the hospital environment. Eligible patients or their family, whanau or friends will be approached and if they consent the patient will be included in the study. If potential participants decline, normal hospital care will be continued. The enrolled participant will receive NIV on the commercially available Visairo mask for one hour during which their ventilatory parameters will be logged. Then the participant will be switched to the OpiNIV Dual investigational mask for another hour. The ventilator data will be collected for these two hours. At the end of the intervention the participant will be reverted to their original mask. The medical staff will be asked to fill out a questionnaire pertaining to the function and usability of the investigational mask compared to the conventional mask.

NIV is an established therapy that delivers positive pressure to the upper airways to provide respiratory support. F\&P have designed a subnasal (under-the-nose) mask that delivers prescribed pressures while improving the efficiency of respiration. This mask has two chambers which encourages dead space washout in the upper airway and minimises CO2 rebreathing, thus delivering more efficient ventilation to the patient and subsequently may reduce the work of breathing. This mask is commercially available under the name OptiNIV (ONIV017). This mask has venting holes and is not compatible with dual limb ventilators.

F\&P have designed the current investigational mask to have the same ventilatory benefits but now for use on dual limb ventilators. Dual limb ventilators operate with less flow than single limb ventilators. As a certain amount of flow is required for the upper airway washout when using OptiNIV. This investigation aims to assess whether the amount of flow required for airway washout does not impact safety, usability and performance of NIV as the comparator.

This study is being conducted prior to commencing clinical benefit studies. The investigational mask is in the development stage.

TO achieve this the enrolled participants will be put on the commercially available Visairo mask, which has a similar under the nose design as the investigational mask, for one hour during which their ventilatory parameters will be logged. Then the participant will be switched to the OpiNIV Dual investigational mask for another hour. The ventilator data will be collected for these two hours. this is done by exporting the vent data via USB. The downloadable data will include the pressures, leak, flows and alarms. At the end of the intervention the participant will be reverted to their original mask. The medical staff will be asked to fill out a questionnaire pertaining to the function and usability of the investigational mask compared to the conventional mask. This will focus on how easy the participant was to get stable on NIV, whether they struggled to get the appropriate pressures set or if they needed to change settings on the vent to achieve therapy. Once the participant has completed both arms the trial is concluded, and the participant will resume normal care.

Eligibility Criteria:
Inclusion Criteria:

* Adults admitted to the ICU prescribed NIV and stable
* Able to receive therapy on a sub-nasal (under-the-nose) mask
* Are 18 years old or older

Exclusion Criteria:

* Contraindicated for NIV
* NIV is likely to fail and/or intubation be required, at the medical staff's discretion
* Bilevel pressure of ≥ 30 cmH2O required
* Do not fit the investigational mask or the standard mask
* Pregnancy (tested under standard care)
* Unable to tolerate NIV for the duration of the investigation
* Agitated
* Unable to understand the consent process