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 100,000 名患者接受全身麻醉。这 当前的全身麻醉实践很容易导致患者过度镇静，这要么是由于缺乏 脑部监测或使用指数不准确的脑部监测器。过度镇静（发生率为 28%） 导致老年人群（≥65 岁）围手术期神经认知障碍（PND）。这 PND 的成本对医疗保健系统来说是巨大的，医疗保健支出至少为 $70B 在美国，每年每名患者每例的长期医疗费用为 4400 万美元 年。 PASCALL 的使命是改善围手术期和术中护理的个性化麻醉。 术中，在 NIA 姊妹基金 AG066325 的支持下，我们开发了 PASCALL Wireless 用于手术室（OR）的脑电图监测系统（M0）以改善麻醉管理， 减少过度镇静并减少长期 PND。我们的系统于五月获得 FDA 批准 2022 年。 该资助项目提出了一项重大创新，将围手术期认知结合起来 使用经 FDA 批准的 PASCALL 监测仪进行术中监测评估，以便及时进行评估 麻醉护理和 PND 的有效监测。 PASCALL 通过以下方式实现了这一创新 三 (3) 个具体目标： （目标 1）开发神经认知障碍围手术期监测测试电池组 (pMiND) 并与 FDA 批准的 Pascall 无线脑电图系统 (PASCALL M0) 集成 （目标 2）开发一种算法来识别手术后风险较高的患者 手术性谵妄和 （目标 3）开发并整合一种评估术中麻醉的方法 Pascall FDA 对手术室 (OR) 脑部监测系统的要求 通过无线脑电图系统（M0） 尽管目前有多种认知评估产品，但没有一个是专为认知评估而设计的。 围手术期监测（目标 1）也无法提供风险评分和麻醉要求 术中监测系统（目标 2-3）。 这个新颖项目的成功将使术前认知评估变得容易 管理。该项目的贡献是改变目前全身麻醉的做法 实现更加个性化的患者护理，特别是对于有 PND 风险的患者群体。这 拟议的项目具有创新性，因为它将术前认知评估与 术中脑状态监测。认知评估的设计是为了可靠性和 适合快节奏手术工作流程的可用性，并且对识别和识别具有高度特异性 减少老年患者的 PND。