Manual ventilation with Ambu bag and normal lung compliance.

Manual ventilation with Ambu bag and low lung compliance.

Manual ventilation with smart bag and normal lung compliance.

Manual ventilation with smart bag and low lung compliance.

Manual ventilation with Ambu bag and Sotair device with normal lung compliance.

Manual ventilation with Ambu bag and Sotair device with low lung compliance.

The device is a durable plastic connector with a silicone flap inside it requiring no special handling. There are no patients involved, only a simulated lung that also requires no special handling. Adult Sotair® device has FDA clearance as a Class II device through the 510(k) pathway (K212905) for the intended use of "Flow-limiting, safe, and optimal manual ventilation to minimize gastric insufflation."

The primary Ventilation endpoint is minute ventilation while manually ventilating the simulated lung over the course of 10 hours.

The major endpoints of the subjects response to performing the manual ventilation will be: Respiratory rate and heart rate; Samn-Perelli 7-point fatigue scale reported hourly; Modified Borg Rating of Perceived Exertion 10-point scale reported hourly.

Secondary endpoints include: tidal volume, peak inspiratory pressure, respiratory rate, and estimated alveolar ventilation while ventilating the simulated lung.