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NCT07577726
Prospective Observational Multimodal Neuromonitoring During High-Risk Adult Surgery
Conditions: Postoperative Cognitive Complications, Delirium, Perioperative/Postoperative Complications, Brain Injuries, Anesthesia
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 300
Sponsor: University of Texas Southwestern Medical Center
Location: UT Southwestern Medical Center - Clements University Hospital Dallas Texas
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* Age 18 years or older
* 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
* Able to provide informed consent (self or legally authorized representative when applicable)
* Safe and feasible placement of SedLine and/or Brain4Care monitoring as determined by the clinical and research teams
* Anticipated availability of perioperative clinical data needed for study analyses
Exclusion Criteria:
* Age younger than 18 years
* Prisoner status
* Pregnancy
* Unable to provide informed consent in English (consent documents available in English only)
* Declining participation
* Lack of subject or legally authorized representative consent when required
* 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)
* Operative workflow or clinical urgency precluding reasonable completion of consent and monitor placement prior to start of surgery
* Anticipated clinical data capture insufficient for meaningful analysis
Source: ClinicalTrials.gov (NCT07577726). StuddyBuddy aggregates publicly available trial information.