Integration of Sotair with Capnography for Standardizing Manual Ventilation Technique and Improving Patient Outcomes

Abstract SafeBVM is transforming emergency ventilation through our innovative Sotair device, addressing the widespread risks of improper manual ventilation. Manual ventilation remains a gold standard of emergency and critical care, yet it is often delivered incorrectly, up to 81% of the time in emergency settings. Unsafe manual ventilation leads to severe complications such as gastric insufflation, aspiration pneumonia, risk of acute lung injury (ALI) and acute respiratory distress syndrome (ARDS), which have hefty treatment costs ranging from $36,000 to $140,000 per patient. These preventable outcomes highlight the critical need for a device that ensures safe and guideline- compliant manual ventilation. The Sotair addresses these challenges through a flow-blocking and pressure- control mechanism which automatically restricts unsafe flow rates exceeding 55 L/min. It also provides real-time audiovisual feedback, guiding providers to adjust their technique for safe and effective ventilation. At just 14 grams, Sotair is lightweight, compatible with all commercially available bag-valve masks and airway devices, and requires no external power source. Its integration into emergency workflows will facilitate personalized ventilation while significantly reducing complications. Based on both studies in the literature and discussions with EMS personnel and key opinion leaders (KOLs), further improvements in ventilation could be gained by integrating a capnography sensor into the Sotair, enabling real-time end-tidal CO₂ (EtCO₂) monitoring as well as ventilation control while also reducing workflow complexity and minimizing dead space. By combining ventilation control with real-time EtCO₂ monitoring, this novel device will not only simplify emergency airway management but also result in further improvements in patient outcomes, reducing life-threatening complications associated with improper manual ventilation. The specific aims of this project are as follows: Aim 1) Design, Engineering, and Prototyping of the Sotair + Capnography Integrated Device. Aim 2) Testing and Preparation of Filing for Regulatory Approval. These efforts will result in the preparation of a comprehensive submission for FDA clearance and will pave the way for successful commercialization of the Sotair device. This innovation positions Sotair as the new gold standard for manual ventilation, enabling safer and more effective care even in resource- limited emergency environments.