Developing an Integrated Brain State Monitor for Personalized Anesthesia Decision Support: Preventing Postoperative Delirium in Elderly and Patients At Risk for Alzheimer's or Related Dementias

Each day, more than 100,000 patients undergo general anesthesia in the United States. 40 percent of the patients receiving anesthesia care are 60 years or older. Post-operative delirium (POD) in these patients has been recognized as a major problem since at least the 1950’s. This project addresses the heightened risk of post-operative delirium (POD) in elderly patients, particularly those with Alzheimer’s disease and related dementias. Existing interventions, like geriatrician involvement and hospital elder life programs (HELP), have shown promise, but their implementation in hospital systems is challenging. Furthermore, current EEG monitors like Medtronic BIS have shown mixed efficacy in POD prevention. Responding to this gap, the PASCALL shall introduces neuroscience-based personalized anesthesia management by integrating our FDA-cleared Wireless Monitor (M0) with Electronic Medical Record (EMR), infusion pumps and anesthesia machine to obtain the needed information to personalize anesthesia decision support. In Aim 1, we seek to establish technical feasibility in connecting with these external systems and devices. In Aim 2, we shall develop the next- generation integrated brain monitoring system (M1) to be FDA-submission ready under appropriate FDA guidance, ISO and ICE standards. In Aim 3, we focus on developing M1 clinical decision support features: 1) accurate age-compensated brain state tracking, 2) anesthetic dose guidance, and 3) POD risk prediction. We shall validate these features using our expansive datasets of N=108,968 subjects across 4 studies. In Aim 4, we shall work with the FDA to determine the regulatory requirements and discuss clinical trial planning.