Development and Commercialization of a pupillometer to predict postoperative opioid-induced respiratory depression in children

项目总结 在美国，每年大约有5000万例手术。阿片类药物通常用作主要的镇痛剂。 以控制严重的手术疼痛。然而，阿片类药物与几种不良反应有关，包括恶心， 呕吐、镇静，以及更严重的呼吸抑制和死亡。呼吸抑制是公认的 作为围手术期阿片类药物最严重、最危及生命和代价最高的并发症之一。虽然 在有有效和早期预测的手术患者中是可以预防的，阿片类药物引起的呼吸 抑郁症仍然是发病率、死亡率、住院时间、医疗费用增加的主要原因 医疗保健和医疗事故索赔。术后阿片类药物诱导呼吸的相关成本 在美国，抑郁症每年超过6.5亿美元，仅儿童就有2.31亿美元。而成年人则有 呼吸和心血管疾病患呼吸抑制的风险很高，尤其是儿童 很脆弱。超过60%的儿童接受扁桃体切除术--这是儿童中最常见的外科手术-- 可能会经历手术后的不良反应，包括呼吸抑制。目前的方法依赖于 使用昂贵的监测和延长的医院对呼吸抑制的反应性和延迟性识别 为病人留下来。目前，还没有有效的工具来主动和可靠地识别高危患者 阿片类药物致术后呼吸抑制。为了解决这一紧迫而未得到满足的需求，NeurOptics 开发一种一流的基于瞳孔测量的工具来主动预测术后呼吸抑制 孩子们。这项技术是基于专利的基于瞳孔测量法的呼吸抑制预测模型 Sadhasivam博士通过他的NIH资助的临床研究开发的。NeurOptics和萨达西瓦姆博士的目标是 通过这一加速的SBIR Fast-Track计划将这项技术广泛应用于临床。在第一阶段， NeurOptics将完成全功能原型、A-100设备和智能患者的开发 接口(IPI)，作为概念验证。此外，在这一阶段，NeurOptics将与FDA接洽 对调控途径的反馈，包括为A-100指定的首个同类突破性设备。 在第二阶段，NeurOptics将生产该设备和患者界面的Beta单元。这些都将得到核实和 用于通过对接受扁桃体切除术的儿童进行的临床研究来验证所提出的技术 是与萨达西瓦姆博士合作进行的。这项技术的围手术期使用将有助于临床医生 预防呼吸抑制，提高阿片类药物的安全性，同时允许医院优化资源。基座 关于当前与阿片类药物流行相关的公共卫生危机和阿片类药物的社会经济负担(&gt；500美元 亿/年)，对于NeurOptics来说，这是一个重要的商业市场，可以主动识别并有效地降低 数百万美国人与阿片类药物相关的不良反应，包括呼吸抑制和过量 年。

PROJECT SUMMARY With about 50 million surgeries performed annually in the US. Opioids are commonly used as primary analgesics to control severe surgical pain. However, opioids are associated with several adverse effects including nausea, vomiting, sedation, and more serious respiratory depression and death. Respiratory depression is recognized as one of the most serious, life threatening and costly complications from perioperative opioids. Although preventable in patients undergoing surgery with effective and early predictions, opioid-induced respiratory depression continues to be a major contributor to increased morbidity, mortality, length of hospital stay, cost of healthcare and malpractice claims. The cost associated with postoperative opioid-induced respiratory depression in the US is over $650 million annually and $231 million for children alone. While adults with respiratory and cardiovascular concerns are at high risk of respiratory depression, children are particularly vulnerable. Over 60% of children undergoing tonsillectomy – the most common surgical procedure in children – are likely to experience adverse post-operative effects including respiratory depression. Current approaches rely on reactive and delayed identification of respiratory depression using costly monitoring and extended hospital stay for patients. Currently, there is no effective tool to proactively and reliably identify patients at high risk of opioid-induced postoperative respiratory depression. To address this urgent and unmet need, NeurOptics is developing a first-in-class pupillometry-based tool to proactively predict postoperative respiratory depression in children. This technology is based on the patented pupillometry-based respiratory depression prediction model developed by Dr. Sadhasivam through his NIH-funded clinical research. NeurOptics and Dr. Sadhasivam aim to bring this technology to wide clinical use through this accelerated SBIR Fast-Track proposal. In Phase I, NeurOptics will complete the development of a fully functional prototype, the A-100 device and Intelligent Patient Interface (IPI), as proof-of-concept. Additionally, during this phase, NeurOptics will engage with the FDA for feedback on the regulatory pathway including the first-of-kind, breakthrough device designation for the A-100. In Phase II, NeurOptics will manufacture beta units of the device and patient interface. These will be verified and used to validate the proposed technology through a clinical study with children undergoing tonsillectomy conducted in collaboration with Dr. Sadhasivam. The perioperative use of this technology will help clinicians to prevent respiratory depression, improve safety of opioids while allowing hospitals to optimize resources. Based on the current opioid-epidemic related public health crisis and socio-economic burden of opioids (>$500 billion/year), a significant commercial market exists for NeurOptics to proactively identify and effectively reduce opioid-related adverse effects including respiratory depression and overdoses in millions of Americans each year.