Validation of Novel Completely Sealed Nasal Positive Airway Pressure Device: SuperNO₂VA™EtCO₂Measurement and Pressure Test Performance

Background: SuperNO2VA™ Et Nasal Mask (Vyaire Medical, Inc., United States) is a new nasal mask with an integrated sampling hood to capture exhaled gases and enable accurate measurements of end tidal carbon dioxide (EtCO2). The authors hypothesized that the SuperNO2VA Et design would measure EtCO2 more accurately than a predicate EtCO2 sampling line, the Smart CapnoLine® Plus, Adult/Intermediate CO2 Oral-Nasal Set (Medtronic, United States). Methods: A simulated patient setup enabled comparison of the accuracy of CO2 measurements within the SuperNO2VA Et and a predicate device for eight condition combinations of input CO2;breath rate and tidal volume (VT);and O2 flow rates. These tests were repeated with simulating Nasal Breathing and Oral Breathing. Results: Testing demonstrated that measurements of 1% and 5% input CO2 within the SuperNO2VA Et were accurate for a range of respiratory rates, VT, O2 flows, and CO2 concentrations. CO2 measurement errors were significantly larger for the Oral-Nasal Set compared to the SuperNO2VA Et for both 1% Input CO2 (-0.12%vol vs. -0.01%vol, p = 0.0005) and 5% Input CO2 (-0.93%vol vs. -0.08%vol, p < 0.0001). At 5% Input CO2, eight of the 12 trials for the Oral-Nasal Set failed to meet the ISO accuracy specification, while all SuperNO2VA Et measurements met the specification. The accuracy of CO2 measurement within the SuperNO2VA were not different for Oral and Nasal Breathing trials for both CO2 concentration (1%: p = 0.33, 5%: p = 0.064). With the Oral-Nasal Set, CO2 measurements were lower during Oral compared to Nasal Breathing (1%: p = 0.0005, 5%: p = 0.0091). Conclusions: Based on performance outcomes, use of the SuperNO2VA Et offers significantly more accurate measurement of EtCO2 than the predicate EtCO2 sampling line. Measurements of EtCO2 within the SuperNO2VA Et are accurate over a range of CO2, breathing rates, tidal volumes, and O2 flows, as well as for nasal and oral breathing.