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

用于预测儿童术后阿片类药物引起的呼吸抑制的瞳孔计的开发和商业化

• 批准号: 10390249
• 负责人: Jeffrey Wade Oliver
• 金额: $ 31.91万
• 依托单位: NEUROPTICS, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-07-01 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10390249
• 关键词: Address; Adult; Adverse effects; Adverse event; Agreement; American; Analgesics; Biological Markers; Cardiovascular system; Cessation of life; Child; Childhood; Classification; Clinical; Clinical Data; Clinical Research; Clinical Trials; Collaborations; Computer software; Data; Data Set; Development; Device or Instrument Development; Devices; Economic Burden; Enrollment; Feedback; Focus Groups; Funding; Gold; Health Care Costs; Hospitals; Intelligence; Legal patent; Length of Stay; Life; Malpractice; Measures; Monitor; Morbidity - disease rate; Nausea and Vomiting; Operative Surgical Procedures; Opioid; Outcome; Output; Overdose; Pain; Pain management; Patients; Pediatric Hospitals; Perioperative; Perioperative complication; Phase; Population; Postoperative Period; Production; Public Health; Recommendation; Regulatory Pathway; Research; Resources; Risk; Safety; Sedation procedure; Small Business Innovation Research Grant; Statistical Methods; Technology; Testing; Time; Tonsillectomy; United States National Institutes of Health; Ventilatory Depression; adverse outcome; base; care costs; cohort; commercialization; cost; design; follow-up; graphical user interface; high risk; improved; innovation; meetings; mortality; novel; opioid epidemic; opioid use; prediction algorithm; predictive modeling; prevent; prototype; respiratory; socioeconomics; success; surgical pain; tool

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.

项目摘要 在美国，每年进行约5000万辆手术。阿片类药物通常用作主要镇痛药 控制严重的手术疼痛。但是，阿片类药物与包括恶心，包括恶心的几种不良反应有关， 呕吐，镇静以及更严重的呼吸道抑郁和死亡。呼吸道抑郁症被认可 作为最严重的，威胁生命和昂贵的阿片类药物的并发症之一。虽然 在接受有效和早期预测的手术的患者中可预防，OIOID诱导的呼吸道 抑郁症继续是增加发病率，死亡率，住院时间，成本的主要因素 医疗保健和渎职索赔。与术后阿片类药物诱导的呼吸道有关的成本 美国的抑郁症每年超过6.5亿美元，仅儿童的抑郁症为2.31亿美元。成年人 呼吸道和心血管问题有呼吸抑郁症的高风险，儿童尤其是 易受伤害的。超过60％的儿童接受扁桃体切除术 - 儿童最常见的外科手术 - 可能会产生不良后术后效应，包括呼吸抑郁症。当前的方法依赖 使用昂贵的监测和延长医院，在反应性和延迟识别呼吸道抑郁症上 留给病人。当前，没有有效的工具可以主动识别出具有高风险的患者 阿片类药物引起的术后呼吸道抑郁症。为了满足这种紧迫而未满足的需求，神经触发是 开发一流的基于化学计量学的工具，以主动预测术后呼吸抑郁症 孩子们。该技术基于获得专利的基于专利的呼吸抑郁预测模型 由Sadhasivam博士通过NIH资助的临床研究开发。 Neuroptics和Sadhasivam博士旨在 通过这项加速的SBIR快速轨道提案，将该技术用于广泛的临床使用。在第一阶段， Neuroptics将完成功能齐全的原型，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互动 有关A-100的首次突破设备名称，包括首个，突破性设备名称。 在第二阶段，神经触发会生产设备和患者界面的β单位。这些将得到验证，并 用于通过接受扁桃体切除术的儿童进行临床研究来验证拟议的技术 与Sadhasivam博士合作进行。该技术的定期使用将帮助临床医生 防止呼吸抑郁症，改善阿片类药物的安全性，同时允许医院优化资源。基于 关于当前的阿片类流动相关公共卫生危机和阿片类药物的社会经济伯恩（> 500美元） 数十亿/年），神经触发能力有一个重要的商业市场，可以主动识别并有效地减少 阿片类药物相关的不良反应，包括呼吸抑郁症和数百万美国人的过量 年。