About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Age younger than 18 years
Prisoner status
Pregnancy
Unable to provide informed consent in English (consent documents available in English only)
Trial population
Adult patients 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. These populations were selected because they commonly experience substantial perioperative hemodynamic and physiologic perturbations.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Proportion of enrolled cases with analyzable SedLine quantitative EEG (Patient State Index) recording during surgery
Percentage of total enrolled cases yielding analyzable SedLine Patient State Index (PSI) epochs during the intraoperative period. Signal quality assessed by artifact burden and data completeness. Reported as a single proportion (percentage of cases with analyzable PSI data) across surgical case types.
Proportion of enrolled cases with analyzable Brain4Care extensometry (P2/P1 ratio) recording during surgery
Percentage of total enrolled cases yielding analyzable Brain4Care (B4C) extensometry P2/P1 ratio epochs during the intraoperative period. Signal quality assessed by artifact burden and adequate waveform morphology. Reported as a single proportion (percentage of cases with analyzable B4C data) across surgical case types.
Correlation between SedLine Patient State Index and intraoperative mean arterial pressure
Spearman correlation coefficient between SedLine-derived Patient State Index (PSI) values and concurrently recorded intraoperative mean arterial pressure. Secondary within-case correlation analyses with vasoactive drug administration epochs, anesthetic transitions, blood loss events, and major surgical epochs will also be reported as correlation coefficients.
Correlation between Brain4Care extensometry P2/P1 ratio and intraoperative mean arterial pressure
Spearman correlation coefficient between Brain4Care (B4C) extensometry-derived P2/P1 ratio values and concurrently recorded intraoperative mean arterial pressure. Secondary within-case correlation analyses with vasoactive drug administration epochs, anesthetic transitions, blood loss events, and major surgical epochs will also be reported as correlation coefficients.
Secondary outcomes
Incidence of postoperative delirium assessed by Confusion Assessment Method (CAM)
Rate of postoperative delirium as documented by Confusion Assessment Method (CAM) assessments in nursing records during the postoperative hospital stay, reported as incidence (percentage of enrolled patients with at least one positive CAM screen). Secondary analyses will examine associations between intraoperative SedLine PSI or B4C P2/P1 ratio features and postoperative delirium occurrence.
Proportion of cases with computable cerebrovascular reactivity indices from Brain4Care extensometry and arterial blood pressure data
Percentage of enrolled cases in which cerebrovascular reactivity-related indices can be computed from acquired Brain4Care (B4C) extensometry waveforms and concurrent arterial blood pressure data, reported as a single proportion with characterization of index distributions across surgical populations.
Functional status at 90 days post-surgery assessed by modified Rankin Scale via medical record review
Functional and neurological status assessed by modified Rankin Scale (mRS) score via medical record review and/or structured contact at up to 90 days from date of surgery. Reported as ordinal mRS score (0-6).
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