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

项目摘要 每年在美国进行大约5000万例手术。阿片类药物通常用作主要镇痛药 来控制剧烈的手术疼痛然而，阿片类药物与几种不良反应有关，包括恶心， 呕吐、镇静、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、危及生命和费用最高的并发症之一。虽然 在接受手术的患者中可通过有效和早期预测预防，阿片类药物诱导的呼吸道疾病 抑郁症仍然是增加发病率、死亡率、住院时间、 医疗保健和医疗事故索赔。与术后阿片类药物诱导的呼吸相关的费用 在美国，抑郁症每年花费超过6.5亿美元，仅儿童就花费2.31亿美元。虽然成年人与 呼吸和心血管问题是呼吸抑制的高风险，儿童尤其是 脆弱超过60%的儿童接受扁桃体切除术-最常见的儿童外科手术- 可能会出现包括呼吸抑制在内的术后不良反应。目前的方法依赖于 使用昂贵的监测和延长住院时间对呼吸抑制的反应性和延迟识别 为病人留下。目前，还没有有效的工具来主动和可靠地识别高风险的患者。 阿片类药物引起的术后呼吸抑制。为了满足这一迫切而未满足的需求，NeurOptics 开发一流的基于瞳孔测量的工具，以主动预测术后呼吸抑制， 孩子这项技术是基于专利的瞳孔测量为基础的呼吸抑制预测模型 由Sadhasivam博士通过他的NIH资助的临床研究开发。NeurOptics和Sadhasivam博士的目标是 通过这一加速SBIR快速通道提案，将这项技术推广到临床应用。在第一阶段， NeurOptics将完成一个功能齐全的原型，A-100设备和智能患者的开发。 接口（IPI），作为概念验证。此外，在此阶段，NeurOptics将与FDA合作， 对监管途径的反馈，包括A-100的首个突破性器械认定。 在第二阶段，NeurOptics将生产设备和患者接口的beta单元。这些将被验证， 用于通过对接受扁桃体切除术的儿童进行临床研究来验证所提出的技术 与Sadhasivam博士合作进行。围手术期使用这项技术将有助于临床医生， 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。基于 关于当前与类阿片流行病有关的公共卫生危机和类阿片的社会经济负担（> 500美元 10亿/年），NeurOptics存在一个重要的商业市场，可以主动识别并有效减少 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.