STTR Phase II: Development of Safety Accessory for Improving Performance and Minimizing Complications of Manual Ventilation

该小型企业技术转让（STTR）第二阶段项目的更广泛影响/商业潜力将是降低标准袋阀面罩（BVM）复苏器引起的并发症风险和相关成本，BVM复苏器广泛用于紧急复苏和气道管理。在美国，每年使用约1310万BVM。医疗提供者经常使用BVM进行不安全的手动通气，无论提供者的资格和经验如何。危险的高压、流速和空气流量可导致并发症，如胃吹入，以及较不常见的吸入性肺炎、急性肺损伤、急性呼吸窘迫综合征、气压伤、体积伤和气胸。迫切需要一种干预措施，以提高患者在使用复苏器袋进行手动通气期间的安全性。该项目涉及开发一种安全装置，与市场上所有标准BVM一起使用，以调节空气流量和压力。该设备将提供安全、经济和优化的通气，同时最大限度地减少胃充气。 该技术应该在整个护理过程中有广泛的应用，特别是在急诊和战场医学中。这个小企业技术转让（STTR）第二阶段项目旨在进一步开发和优化BVM安全性。这一努力优化了提供者在使用设备时接收到的触觉和听觉反馈，并优化了产品的设计和可制造性。此外，该器械在麻醉猪和心脏骤停猪中的生物相容性研究和动物研究将提供FDA批准所需的数据。这项第二阶段的工作将确保患者将获得最佳的循证治疗，并将有助于建立安全设备作为标准的护理。该奖项反映了NSF的法定使命，并已被认为是值得通过评估使用基金会的知识价值和更广泛的影响审查标准的支持。

The broader impact/commercial potential of this Small Business Technology Transfer (STTR) Phase II project will be to reduce the risk of complications and associated costs caused by standard bag valve mask (BVM) resuscitators, which are widely used in emergency resuscitation and airway management. In the United States, about 13.1 million BVMs are used annually. Medical providers frequently deliver unsafe manual ventilation with BVMs, regardless of the qualifications and experience of the provider. Dangerously high pressures, flow rates, and volumes of air flow can result in complications such as gastric insufflation, and less frequently, aspiration pneumonia, acute lung injury, acute respiratory distress syndrome, barotrauma, volutrauma, and pneumothorax. There is an urgent need for an intervention to improve patient safety during manual ventilation with the resuscitator bag. This project involves the development of a safety device to be used with all standard BVMs on the market to regulate air flow and pressure. The device that will offer safe, affordable, and optimized ventilation while minimizing gastric insufflation. The technology should have broad applications across the entire care continuum, but especially in emergency and battlefield medicine.This Small Business Technology Transfer (STTR) Phase II project seeks to further develop and optimize the BVM safety. This effort optimizes the haptic and auditory feedback the provider receives when using the device and optimizes the design and manufacturability of the product. In addition, biocompatibility studies and animal studies of the device in anesthetized pigs and in pigs undergoing cardiac arrest will provide data necessary for FDA clearance. This Phase II work will ensure that patients will receive the most optimal evidence-based treatment and will help establish the safety device as the standard of care.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.