Sotair – SafeBVM

71%

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

The Solution

SafeBVM’s award winning Sotair device is funded by grants and contracts from NIH, NSF, Military and Air Force. It revolutionizes manual ventilation with its flow-limiting valve, regulating air flow above 55 LPM, thereby preventing high peak air pressures. Regulation of air flow has been shown to reduce excessive volume and respiratory rates, reducing the risk of over ventilation and hyperventilation.

Sotair’s design is intuitive and only requires 30 seconds for training. The device provides real-time, multi-sensory feedback (haptic, auditory, visual) to guide providers, enhancing adaptability and consistency in patient care no matter the patient type or lung condition.

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.

ADULT Sotair® Device Features

FDA 510(k) cleared for Adult, single patient use
Prevents high air flow rates (>55LPM) during manual ventilation, thereby limiting peak air pressures. Regulation of airflow helps reduce excessive tidal volumes and breath delivery rates, minimizing the risk of over-ventilation and hyperventilation
Intended to minimize air entry into the stomach
Immediate real-time haptic auditory and visual feedback
Decreases provider variability and improves consistency of ventilation
30 second basic training

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.

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