Of the time, air enters the stomach when ventilating the lungs with a manual resuscitator (2)
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 blocks the flow of air at 55 L/min. For an average adult, this corresponds to a maximum pressure generated of approximately 20 cmH2O. Air enters the stomach beyond this corresponding pressure threshold.
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.
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.
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>.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, underventilation and overventilation.(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 38% improvement in manual ventilation.
Awarded a small business grant for the development and commercialization of SafeBVM’s technology
Selected for the 2021 program focused on healthcare companies that are looking to improve care,reduce cost sand create new efficient approaches to problems with in the medical industry
Publication showing the enefits of Sotair as a potential solution to reduce barotrauma, overventilation, and under ventilation in periods of extended manual ventilation
Awarded 2 grants by the NIH, one Phase II SBIR/STTR grant, and one grant in collaboration with Umass Memorial Medical Center
Awarded a Phase ISBIR contract by the AFWERX/AFV entures initiative of the US AirForce
SafeBVM was selected in the highly competitive NASDAQ’s Milestone Makers Program
SafeBVM was a part of the 100 companies that were selected for the 2020 Mass Challenge Boston cohort
Out of 130 companies, SafeBVM was one of the two companies that were awarded grants by the AHA
won the Gold Prize in the Life Science Design category in the 2019 European Product Design Awards
These projects will advance the science of emergency airway management. The technology will fit into the existing treatment workflow and supply chain while addressing the need for safer ventilation during COVID-19
The James Dyson Award is an international design award that celebrates, encourages and inspires the next generation of design engineers
1st place at the University of Minnesota’s 2019 Design of Medical Devices Conference
SafeBVM selected as finalist at the 2022 EMS WORLD EXPO Innovation Awards & winner at the 2019 EMS WORLD EXPO Innovation Awards
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 FAEMS
Medical 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, FAARC
Chairman, Department of Respiratory Therapy,
Georgia State University
