71%
Of the time, air enters the stomach when ventilating the lungs with a manual resuscitator.9
The Solution
Sotair employs a flow blocking and pressure control valve mechanism to minimize complications associated with overventilation. The Sotair minimizes excessive pressure in the airway system without venting air by capping peak flow rates at 55 L/min.
Pressure Delivered During Manual Ventilation
Sotair limits the flow of air at 55 L/min. For an average adult, this corresponds to a maximum pressure of approximately 20 cmH2O. Air enters the stomach beyond 20 cmH2O causing gastric insufflation.
Features of the ADULT Sotair Device
- Flow limiting valve limits the inspiratory flow to 55L/min
- Minimizes air entry into the stomach
- Compatible with manual resuscitators, airway and adjuncts that use standard 15/22 mm connectors
- Hospital, emergency, and transport care use
- Adult, single patient use
How Does Sotair Work?
When flow rates delivered with the bag exceed 55 L/min, the device activates and blocks the flow of air providing haptic, auditory, and visual feedback to the user.
Flow <=55L/min Valve not activated Air delivery
Flow >55L/min Valve activated No Air delivery
The ADULT Sotair Device in the British Medical Journal, Innovations
During the COVID-19 pandemic, it was anticipated that there will be a shortage of mechanical ventilators. An alternative may be to implement manual ventilation in these situations. 47 volunteer providers completed two, one-hour manual ventilation sessions. Providers were randomized to complete their initial session either with or without Sotair.
Sotair Performance, Closer to a Ventilator's
The study showed wide variability in tidal volume and peak pressures in the bag alone arm of the study despite prior training. Additionally, peak pressures (p>.0001) and tidal volumes (p>0.0001) were significantly improved with the Sotair device and authors concluded that extended manual ventilation may be feasible with a safety device, which may reduce barotrauma, under-ventilation and over-ventilation.10
GRANT-FUNDED CASE STUDY
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
Pre-Post Sotair Implementation at a Fire & EMS Service
SafeBVM's device limits flow delivered and can be utilized with monitoring devices if needed. This solution to manual ventilation is a must for reducing harmful pressure during emergency care, in and out of the hospital. This device will be an excellent tool that Respiratory Therapists worldwide will utilize to provide a safe means of resuscitation.
Douglas S. Gardenhire, EdD, RRT-NPS, FAARCChairman, Department of Respiratory Therapy, Georgia State University 
Testimonials
safeBVM’s device does limit pressure delivered and can be utilized with monitoring devices if needed. This inexpensive accessory to manual ventilation is a must at reducing harmful pressure during emergency care in and out of the hospital. Once approved, this device will be a tool that Respiratory Therapists (RTs) around the world will utilize to provide a safe means for resuscitation. I look forward to a successful collaboration that can assist in making manual ventilation safer in the future
Joe Holley,MD FACEP FAEMSMedical Director of the State of Tennessee EMS,
Associate Professor in Emergency Medicine at University of Tennessee Health Science Center
safeBVM’s device does limit pressure delivered and can be utilized with monitoring devices if needed. This inexpensive accessory to manual ventilation is a must at reducing harmful pressure during emergency care in and out of the hospital. Once approved, this device will be a tool that Respiratory Therapists (RTs) around the world will utilize to provide a safe means for resuscitation
Douglas S. Gardenhire,EdD, RRT-NPS, FAARCChairman, Department of Respiratory Therapy,
Georgia State University
Previous
Next
