SafeBVM’s flagship innovation, the award-winning Sotair® device, is primarily funded by grants and contracts from the National Institutes of Health (NIH), National Science Foundation (NSF), and the Military.
Sotair is a small, lightweight, easy to use flow control valve that fits between a manual resuscitator and a patient mask or airway. The valve prevents flow rates of air from exceeding 55 LPM during manual ventilation, ensuring that air delivery stays within safe limits. Flow control helps reduce peak airway pressures, excessive tidal volumes and excessive breath delivery rates, minimizing the risk of over-pressurization, over-ventilation and hyperventilation.
Sotair’s user-friendly design requires only 30 seconds of training. The device offers multi-sensory feedback (haptic, auditory, visual) to guide providers in real-time, enhancing adaptability and consistency while reducing variability in performance during manual ventilation.
If a manual resuscitator is squeezed too fast or too forcefully and flow exceeds 55 LPM, Sotair’s valve closes, creating resistance and triggering tactile and auditory feedback alarms with visual cues. This feedback helps the provider correct their squeeze and deliver ventilation tailored to the patient’s lung condition.
While Sotair has a static flow limit of ~55 LPM, the output peak pressure delivered to the patient is dynamic depending on the patients lung compliance and resistance. For example, for an average adult with healthy lungs, Sotair’s flow limit of 55 LPM corresponds to a maximum peak pressure delivered of approximately 20 cmH2O, when air starts to enter the stomach. In other the disease states like COPD, Asthma or ARDS, the peak pressure generated by the user may be in the 20-30+ cmH2O as they have decreased lungs compliance and/or increased airway resistance.
By acting as a ‘forcing function,’ Sotair® forces the right actions, avoiding rapid, forceful squeezes that lead to over-ventilation.
During the COVID-19 pandemic, a ventilator shortage was anticipated, making manual ventilation a potential alternative. 47 volunteers completed two one-hour manual ventilation sessions, randomized to start with or without Sotair.
Sotair reduces variability in manual ventilation, bringing performance closer to mechanical ventilators.
Authors concluded that extended manual ventilation may be feasible with a safety device, which may reduce barotrauma, under-ventilation and over-ventilation.7
Peak pressures (p>.0001) and tidal volumes (p>0.0001) were significantly improved with the Sotair® device.
Grant 1U54HL143541 (NHLBI) funded a 40-provider pilot bench evaluation of Sotair® with North Providence Fire Station. Implementation of Sotair® showed a 36% improvement in manual ventilation.11
