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10万名病人接受全身麻醉。的