[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638143":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":16,"locations":21,"responsibleParty":43,"collaborators":10,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":10,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":10,"enrollmentInfo":55,"targetDuration":10,"studyType":58,"phases":10,"briefSummary":59,"conditions":60,"keywords":66,"overallStatus":82,"whyStopped":10,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"University of Texas Southwestern Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"High-Risk Surgical Patients",null,"Adult patients age 18 years or older undergoing major spine surgery, liver transplantation, on-pump cardiac surgery, major vascular surgery, major thoracic surgery, major abdominal surgery, or neurosurgical craniotomy at UT Southwestern Medical Center. All participants undergo SedLine qEEG data capture from existing standard-of-care clinical monitoring. A subset additionally undergo B4C noninvasive intracranial dynamics monitoring as a research device.",[13],{"name":14,"affiliation":5,"role":15},"Noah Jouett, DO, PhD","PRINCIPAL_INVESTIGATOR",[17],{"name":14,"role":18,"phone":19,"phoneExt":10,"email":20},"CONTACT","2147862783","Noah.Jouett@UTSouthwestern.edu",[22],{"facility":23,"status":10,"city":24,"state":25,"zip":26,"country":27,"countryCode":28,"cosmosGeoPoint":29,"geoPoint":34,"contacts":35},"UT Southwestern Medical Center - Clements University Hospital","Dallas","Texas","75390","United States","US",{"type":30,"coordinates":31},"Point",[32,33],-96.80667,32.78306,{"lat":33,"lon":32},[36,37,38,41],{"name":14,"role":18,"phone":19,"phoneExt":10,"email":20},{"name":14,"role":15,"phone":10,"phoneExt":10,"email":10},{"name":39,"role":40,"phone":10,"phoneExt":10,"email":10},"Ulrike Hoffmann, MD, PhD","SUB_INVESTIGATOR",{"name":42,"role":40,"phone":10,"phoneExt":10,"email":10},"Peiman Lahsaei, MD",{"type":15,"investigatorFullName":44,"investigatorTitle":45,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Noah Jouett","Principal Investigator, Department of Anesthesiology and Pain Management","100638143","prospective-observational-multimodal-neuromonitoring-during-high-risk-adult-surgery-100638143",false,"NCT07577726","Prospective Observational Multimodal Neuromonitoring During High-Risk Adult Surgery","Prospective Observational Multimodal Neuromonitoring During High-Risk Adult Surgery: A Single-Center Cohort Study of Quantitative EEG, Noninvasive Intracranial Dynamics, and Perioperative Physiologic Correlates","Inclusion Criteria:\n\n* Age 18 years or older\n* Scheduled to undergo major spine surgery, liver transplantation, on-pump cardiac surgery, major vascular surgery, major thoracic surgery, major abdominal surgery, or neurosurgical craniotomy at UT Southwestern Medical Center\n* Able to provide informed consent (self or legally authorized representative when applicable)\n* Safe and feasible placement of SedLine and\u002For Brain4Care monitoring as determined by the clinical and research teams\n* Anticipated availability of perioperative clinical data needed for study analyses\n\nExclusion Criteria:\n\n* Age younger than 18 years\n* Prisoner status\n* Pregnancy\n* Unable to provide informed consent in English (consent documents available in English only)\n* Declining participation\n* Lack of subject or legally authorized representative consent when required\n* Clinical condition preventing safe or feasible placement of study monitors (e.g., incompatible surgical field location, significant facial or scalp injury, open wounds at intended sensor placement site)\n* Operative workflow or clinical urgency precluding reasonable completion of consent and monitor placement prior to start of surgery\n* Anticipated clinical data capture insufficient for meaningful analysis","ALL","18 Years",{"count":56,"type":57},300,"ESTIMATED","OBSERVATIONAL","This is a prospective observational cohort study of adult patients undergoing high-risk surgery at UT Southwestern Medical Center. The study acquires synchronized multimodal neuromonitoring data - including SedLine quantitative EEG (qEEG) extracted from standard-of-care clinical monitoring and, where deployed, Brain4Care (B4C) noninvasive intracranial dynamics data - and links these data to perioperative hemodynamic, medication, laboratory, procedural, and outcome variables. No alteration of routine clinical care occurs. The primary goal is to characterize associations between monitor-derived features and perioperative clinical variables, and to establish a multimodal dataset supporting future analyses of perioperative brain health in high-risk surgical populations.",[61,62,63,64,65],"Postoperative Cognitive Complications","Delirium","Perioperative\u002FPostoperative Complications","Brain Injuries","Anesthesia",[67,68,69,70,71,72,73,74,75,76,77,78,79,80,81],"quantitative EEG","SedLine","Brain4Care","intracranial dynamics","cerebrovascular reactivity","perioperative neuromonitoring","postoperative delirium","perioperative brain health","cardiac surgery","liver transplantation","spine surgery","Moberg Clinical Platform","cerebral autoregulation","high-risk surgery","intraoperative monitoring","NOT_YET_RECRUITING","2026-05-04",{"date":85,"type":86},"2026-05-11","ACTUAL",{"date":88,"type":57},"2026-07",{"date":90,"type":57},"2028-12",{"name":5,"class":6},1]