Evaluation of SuperNO₂VA™ mask technology in a clinical setting: A pilot study

Background: One of the biggest challenges for anesthesia practitioners during airway management is the maintenance of adequate oxygenation and ventilation during difficult and emergency airway situations. Providing nasal ventilation during the “apneic period” defined as the time between the end of bag-mask ventilation and successful placement of an appropriate airway device, may allow for improved oxygenation throughout the process in which the airway is secured. The SuperNO₂VA™ mask (Revolutionary Medical Devices, USA) is a newly developed nasal mask that delivers non-invasive positive pressure nasal ventilation that is designed to provide continuous oxygenation and ventilation during anesthetic induction until the airway is secured. Aim: The purpose of this study was to evaluate the clinical performance of the SuperNO₂VA™ mask for nasal oxygenation and ventilation during pre-induction, post-induction, laryngoscopy, and tracheal intubation in adult patients requiring general anesthesia. Methods: Following IRB/ethical board approval and written informed consent, 30 adult patients, ages 18 years or older, with an ASA status I-III, who were scheduled for an elective surgery that required general anesthesia and tracheal intubation, were enrolled into this study. Patient demographic characteristics and intervening outcomes were all recorded. The SuperNO₂VA™’s efficacy was evaluated by the measurement and recorded values of peak airway pressures, tidal volumes, minimal oxygen saturation values (while the airway was secured), as well as, an objective assessment grading scale for mask ventilation. The time required to secure the airway, including laryngoscopy, was also recorded. Results: The SuperNO₂VA™ nasal mask provided adequate oxygenation and successful ventilation in 29 of 30 patients, resulting in an overall success rate of 97% (95% confidence interval: 83%–100%). One patient was unable to be successfully ventilated by the SuperNOVA™ mask and was noted a Grade IV. The mean duration of laryngoscopy was 50.7 ± 23.2 s, with an average SpO₂ of 99.6 ± 0.8% calculated for this interval. The lowest observed SpO₂ for the 29 patients at preoxygenation, pre-induction, pre-ETT insertion, during laryngoscopy, post-intubation, and in the PACU was 95, 97, 97, 97, 98, and 94%, respectively. The average for the lowest SpO₂ during the entire airway procedure was 98.1 ± 7.0%. And the average peak airway pressure, for all 29 patients, was 17.97 ± 3.95 mmHg, with a mean tidal volume of 573.7 ± 40.7 mL. Conclusion: This observational study demonstrated that the SuperNO₂VA™ mask facilitates non-invasive positive pressure ventilation while providing adequate oxygenation and ventilation during pre-induction, post-induction, laryngoscopy, and tracheal intubation in elective surgical patients. Conversely, considering the novelty of this particular study, further research is warranted to determine its usefulness in patients with known/predicted difficult airways, or even during emergent situations.