SBIR Phase I: Development of Safety Accessory for Improving Performance and Minimizing Complications of Manual Ventilation (COVID-19)

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The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project includes improved performance and minimized complications of manual ventilation through the development of a cost-efficient and user-friendly medical device. The bag valve mask (BVM) is used during first-response and emergencies to manually deliver air to patients unable to breathe on their own. Approximately 13.1 million BVMs are used annually in the United States. Due to a lack of feedback mechanisms, providers are unable to judge their compliance with ventilation recommendations, resulting in a high incidence of life-threatening complications. In the intensive care unit, mechanical ventilators are used for safe and precise air delivery, but the quality is different. This project prevents complications of unsafe manual ventilation, thereby improving the quality of care and providing cost savings for the health system. The project will help bridge the gap between manual and mechanical ventilation, aiding first responders in the COVID-19 pandemic. This Small Business Innovation Research (SBIR) Phase I project will advance the science of emergency airway management. This technology will fit into the existing treatment workflow and supply-chain while addressing the need for safer ventilation during COVID-19. Improper manual ventilation due to delivery of unsafe pressures, volume, or frequency is common and occurs regardless of a provider's training or experience. The prevalence and severity of the problem have been studied extensively, establishing the need for the device. The research and development goal is to develop a device that can achieve performance and safety closer to a ventilator. Studies include characterizing usability, performance, efficacy, and biocompatibility.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.