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.

在美国，每天有超过10万名患者接受全身麻醉。这个 目前全身麻醉的做法容易使患者过度镇静，要么是因为缺乏 大脑监测或使用指数不准确的大脑监测器。过度镇静(发生率为28%) 导致老年人群围手术期神经认知障碍(PND)(≥65岁)。这个 PND的成本对医疗系统来说是巨大的，至少有700亿美元的医疗支出 美国每年的长期医疗费用为每个患者每个病例4400万美元 年。 Pascall的使命是在围手术期和术中护理中改善个性化麻醉。 术中，在NIA姊妹格兰特AG066325的支持下，我们开发了Pascall Wireless 脑电监测系统(M0)用于手术室(OR)，以改善麻醉管理， 减少过度镇静，减少长期PND。我们的系统在五月份通过了FDA的审批 2022年 这一赠款项目提出了一项重大的创新，将围手术期的认知 使用Pascall FDA批准的监护仪对术中监护进行评估，以实现及时 PND的麻醉护理和有效监测。Pascall通过以下方式实现了这一创新 三(3)个具体目标： (目标1)研制神经认知障碍围手术期监测测试组合 (PMiND)并与Pascall FDA批准的无线脑电系统(Pascall M0)集成 (目标2)开发一种算法来识别外科手术后风险较高的患者- 手术后精神错乱和 (目标3)开发和整合一种估计术中麻醉剂的方法 帕斯卡FDA对手术室(OR)脑监测系统的要求- 无线脑电系统(M0) 尽管目前有许多认知评估产品，但没有一个是为 围手术期监测(目标1)也不能提供危险评分和麻醉要求 术中监护系统(目标2-3)。 这一新项目的成功将使术前认知评估变得容易 管理。这个项目的贡献是改变目前全身麻醉的做法 走向更个性化的患者护理，特别是针对PND高危人群。这个 提议的项目具有创新性，因为它结合了术前认知评估和 术中脑状态监测。认知评估的设计是为了可靠性和 可用性，以适应快节奏的手术工作流程，并高度特定于识别和 老年患者PND的减少。