Sotair – SafeBVM

71%

Of the time, air enters the stomach when ventilating the lungs with a manual resuscitator.⁹

The Solution

SafeBVM’s flagship innovation, the award-winning Sotair device, is primarily funded by grants and contracts from the NIH, NSF, and the Military. Sotair revolutionizes manual ventilation with its flow-limiting valve, ensuring providers deliver air at peak flows of less than 55 LPM, thereby preventing high peak air pressure delivery. This regulation of airflow has also been shown to reduce the risk of overventilation 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.

How Does Sotair® Work?

When flow rates delivered with the bag exceed 55 L/min, the device activates and limits the flow of air providing haptic, auditory, and visual feedback to the user.

Dynamic Pressure Delivery

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.

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

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 Learn More

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

Douglas S. Gardenhire,
EdD, RRT-NPS, FAARCChairman, Department of Respiratory Therapy,
Georgia State University