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The Problem
The Problem
The manual resuscitator, or bag valve mask (BVM), represents the standard means for providing emergency ventilatory support. Despite its widespread use and the essential role it plays, it remains a skill with high variability regardless of a healthcare provider’s qualifications, training, experience, or confidence.
This may be attributable to inherent challenges in an emergency situation, coupled with the minimal safeguards available with BVM. Such variability can lead to hyperventilation, including overventilation, and/or hypoventilation, including underventilation, each carrying risks of severe complications such as aspiration pneumonia, lung injury, Acute Respiratory Distress Syndrome (ARDS) and even death.
Pressure Delivered During Manual Ventilation
The Solution:
The ADULT Sotair® Device
- FDA 510(k) cleared for Adult, single patient use
- Sotair is a flow control valve that fits between a manual resuscitator and a patient mask/airway. The valve prevents flow rates of air from exceeding 55 LPM during manual ventilation
- Regulation of airflow helps reduce peak airway pressures, excessive tidal volumes¹ and excessive breath delivery rates,² minimizing the risk of over-pressurization, over-ventilation and hyperventilation
- Sotair acts as a ‘Forcing Function,’ constraining the provider to deliver safer manual ventilation with less variability. This is most effective in ensuring system-wide change¹ ³
- 100% activation and flow limiting testing ensures reliability in performance
High Provider Variability
98%
Of responders delivered at least one breath that was inadequate or excessive per 90-second period.8
Our Supporters
Awarded a Technology/Therapeutic Development Grant as a part of the Military Medical Research and Development program by the Department of Defense (DoD)
Awarded 2 grants by the NIH, one Phase II SBIR/STTR grant, and one grant in collaboration with UMASS Memorial Medical Center
Awarded Phae I SBIR contract by the AFWERX/AF Ventures initiative of the US Air Force
Awarded Phase I & II SBIR/STTR grants by the National Science Foundation
Sotair (1st & 2nd gen) was selected as a winner in 2019 and 2022 for the EMSWORLD Innovation Awards
Selected in 2020's International Top 20 (out of 1800)
Out of 130 companies, SafeBVM was 1 of 2 companies that were awarded grants
Won Gold Prize in the 2019 European Design Awards
Awarded a small business grant for the development and commercialization of SafeBVM's technology
Selected for the 2021 program focused on companies looking to improve care, reduce costs and create new efficient approaches to problems within the medical industry
Selected into the highly competitive NASDAQ Milestone Makers Program
Won 1st place at the University of Minnesota's 2019 Design of Medical Device Conference
Sotair was published as a potential solution to reduce barotrauma, overventilation, and underventilation in periods of extended manual ventilation
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
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