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The Problem
The Problem
- The manual resuscitator, also known as the bag valve mask (BVM), is the standard means of providing emergency ventilatory support.
- Poor manual ventilation technique is a well-documented problem that occurs irrespective of a provider’s qualifications, training, experience, and confidence.
- There are minimal safeguards for manual ventilation with a BVM. This results in high provider variability in breath delivery and can lead to serious complications.8
Pressure Delivered During Manual Ventilation
High Provider Variability
98%
Of responders delivered at least one breath that was inadequate or excessive per 90-second period.8
Solution
MVIP
- SafeBVM’s Manual Ventilation Improvement Program (MVIP) focuses on 4 pillars: assessment, education, skills competency, and safety/quality improvement.
- This turn-key training program addresses every aspect of manual ventilation and ensures that the provider’s skills are sharp year-round.
- MVIP includes the implementation of SafeBVM’s award-winning and recently FDA-cleared medical device, the Adult Sotair® Device, in the field to reinforce what providers learned and minimize patient harm.
71%
Of the time, air enters the stomach when ventilating the lungs with a manual resuscitator.9
The ADULT Sotair® Device
- Air enters the stomach (gastric insufflation) at peak pressures crossing 20-22 cmH2O.1,2,3
- Sotair® limits the flow of air at 55 L/min. For an adult with normal lung compliance and resistance, this corresponds to a maximum pressure of approximately 20 cmH2O.
- Adult Sotair® Device received 510 (k) clearance from the US FDA for minimizing gastric insufflation.
- Because Sotair® functions based on flow and not pressure, it can safely ventilate patients with a collapsed lung causing lower compliance or obstructed airway with a high resistance.
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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