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

这个小型企业创新研究(SBIR)第一阶段项目的更广泛的影响/商业潜力包括通过开发一种经济高效和用户友好的医疗设备来提高人工通风的性能并将并发症降至最低。袋式阀门面罩(BVM)在急救和紧急情况下使用，以手动向无法自主呼吸的患者输送空气。在美国，每年大约有1310万台BVMS被使用。由于缺乏反馈机制，提供者无法判断其对通风建议的遵守情况，导致危及生命的并发症发生率较高。在重症监护病房，使用机械呼吸机是为了安全和精确地输送空气，但质量不同。该项目可预防不安全的人工通风并发症，从而提高护理质量，并为卫生系统节省费用。该项目将有助于弥合人工通风和机械通风之间的差距，帮助应对新冠肺炎疫情的急救人员。这一小型企业创新研究(SBIR)第一阶段项目将推进紧急呼吸道管理的科学。这项技术将融入现有的治疗工作流程和供应链，同时满足新冠肺炎期间对更安全通风的需求。由于输送不安全的压力、流量或频率而导致的不适当的手动通风是很常见的，无论提供者的培训或经验如何，都会发生这种情况。已经对问题的普遍性和严重性进行了广泛的研究，确定了对该设备的需求。研发目标是开发一种能够实现更接近呼吸机的性能和安全性的设备。研究包括可用性、性能、有效性和生物兼容性。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

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.