Developing a novel system combining cognitive assessment with PASCALL FDA-cleared intraoperative anesthesia EEG brain monitor to prevent postoperative neurocognitive disorders in aging patients

开发一种将认知评估与 FDA 批准的 PASCALL 术中麻醉脑电图脑监测仪相结合的新型系统，以预防老年患者术后神经认知障碍

• 批准号: 10760816
• 负责人: Tuan Le Mau
• 金额: $ 29.99万
• 依托单位: PASCALL SYSTEMS, INCORPORATED
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-30 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10760816
• 关键词: Age; Aging; Algorithms; Anesthesia procedures; Anesthetics; Brain; Caring; Categories; Clinical; Cognitive; Computer software; Computerized Medical Record; Data; Dexmedetomidine; Elderly; Electroencephalography; Expenditure; Funding; General Anesthesia; General Practices; Grant; Health Care Costs; Health Expenditures; Healthcare Systems; Impaired cognition; Incidence; Industry; Intervention; Intraoperative Care; Intraoperative Monitoring; Ketamine; Legal patent; Length of Stay; Life; Long-Term Care; Marketing; Measures; Medicare; Methods; Mission; Modeling; Monitor; Nature; Neurocognitive; Neuropsychological Tests; Neurosciences; Nitrous Oxide; Operating Rooms; Operative Surgical Procedures; Outcome; Patients; Perioperative; Pharmaceutical Preparations; Phase; Physiological; Population; Populations at Risk; Postoperative Period; Privatization; Regulation; Reporting; Research Design; Rights; Risk; Risk Reduction; Science; Screening procedure; Sedation procedure; Sister; Site; Small Business Technology Transfer Research; Specific qualifier value; System; Systems Integration; Testing; United States; United States National Institutes of Health; brain electrical activity; brief screening; cognitive testing; cost; design; drug action; economic cost; human old age (65+); improved; indexing; innovation; multidisciplinary; neurocognitive disorder; novel; older patient; patient population; personalized care; population based; post-operative cognitive dysfunction; postoperative delirium; prevent; screening; societal costs; success; tool; usability; wireless

Each day, more than 100,000 patients undergo general anesthesia in the United States. The current practice of general anesthesia is prone to over-sedating patients, either due to the lack of brain monitoring or using brain monitors with inaccurate indices. Over-sedation (at 28% incidence) contributes to perioperative neurocognitive disorders (PNDs) in elderly population (≥65yrs). The cost of PND is enormous to the healthcare system, at least $70B in healthcare expenditures annually in the United State with the long-term healthcare cost at $44M per patient per case per year. PASCALL mission is to improve personalized anesthesia across peri- and intra-operative care. Intraoperatively, supported by NIA sister grant AG066325, we developed PASCALL Wireless EEG monitoring system (M0) for the operating room (OR) to improve anesthesia management, reduce over-sedation and reduce long-term PND. Our system received FDA clearance in May 2022. This grant project proposes a significant innovation that combines perioperative cognitive assessment with intraoperative monitoring using PASCALL FDA-cleared monitor to enable timely anesthesia care and effective monitoring of PNDs. PASCALL realizes this innovation through three (3) specific aims: (Aim 1) To develop Perioperative Monitoring of Neurocognitive Disorders test battery (pMiND) and integrate with Pascall FDA-cleared Wireless EEG system (PASCALL M0) (Aim 2) To develop an algorithm to identify surgical patients at greater risk of post- operative delirium and (Aim 3) To develop and integrate a measure to estimate intra-operative anesthetic requirements to brain monitoring systems in the operating room (OR) into Pascall FDA- cleared Wireless EEG system (M0) Although there are a multitude of current cognitive assessment products, none were designed for perioperative monitoring (Aim 1) nor able to provide at-risk score and anesthetic requirement to an intraoperative monitoring system (Aim 2-3). The success of this novel project will make pre-operative cognitive assessment easy to administer. The contribution of this project is to shift current practices of general anesthesia towards more personalized patient care, especially for patients’ population at risk with PND. The proposed project is innovative because it combines preoperative cognitive assessment with intraoperative brain state monitoring. The cognitive assessment is designed for reliability and usability to fit the fast-paced surgery workflow and highly specific to the identification and reduction of PND in elderly patients.

每天，美国有100,000多名患者在美国接受全身麻醉。这 当前全身麻醉的做法容易容易过度隔离患者，要么是由于缺乏 大脑监测或使用脑部监测器，指数不准确。过度分析（发病率为28％） 在古老的人群（≥65岁）中有助于定期神经认知障碍（PND）。这 PND的费用是医疗系统的巨大，至少$ 70B的医疗保健支出 在美国，长期医疗保健费用为每例患者4400万美元 年。 Pascall任务是改善跨周期和术中心的个性化麻醉。 术中，在Nia Sister Grant AG066325的支持下，我们开发了Pascall Wireless 手术室（OR）的脑电图监测系统（M0）改善麻醉管理， 减少过度调整并减少长期PND。我们的系统在5月获得了FDA的通关 2022。 该赠款项目提出了一项重大创新，结合了定期认知 使用PASCALL FDA清理显示器进行术中监测评估，以及时启用 麻醉护理和对PND的有效监测。 Pascall通过 三（3）个具体目的： （目标1）开发对神经认知障碍测试电池的围手术期监测 （PMIND）并与Pascall FDA清除无线EEG系统（Pascall M0）集成 （目标2）开发算法以识别出更大风险的外科手术患者 手术ir妄和 （目标3）开发和整合一项措施以估计术中麻醉 对手术室中的大脑监测系统（OR）的要求（OR）进入Pascall FDA- 清除的无线脑电图系统（M0） 尽管当前有许多认知评估产品，但没有一个专为 定期监控（AIM 1）也不能在风险中分数和麻醉要求 术中监测系统（AIM 2-3）。 这个新颖项目的成功将使术前认知评估易于 管理。该项目的贡献是改变全身麻醉的当前实践 面向更个性化的患者护理，尤其是针对PND风险的患者人群。 拟议的项目具有创新性，因为它将术前认知评估与 术中大脑状态监测。认知评估专为可靠性和 适合快节奏的手术工作流程的可用性，并且高度特定于识别和 老患者的PND减少。