Prolonged Manual Ventilation Simulation

Condition(s) studied

Investigational drug(s) / intervention(s)

Sotair: 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."

Study summary

A pilot study on simulated lung scenarios using the standard manual resuscitator bag, flow limiting resuscitator bag, and an FDA approved flow rate limiting device paired with a standard manual resuscitator.

Eligibility

Primary outcome measure(s)

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

Trial sites (1)