Anesthesia, Brain Injuries, Delirium, Perioperative/Postoperative Complications, Postoperative Cognitive Complications
Conditions
Keywords
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
Brief 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.
Detailed description
BACKGROUND: Patients undergoing major spine surgery, liver transplantation, on-pump cardiac surgery, major vascular surgery, major thoracic surgery, major abdominal surgery, and neurosurgical craniotomy are exposed to substantial perioperative physiologic stress, including hemodynamic instability, blood loss, cardiopulmonary bypass, and procedure-specific periods of altered cerebral perfusion. Quantitative electroencephalography and noninvasive assessments of intracranial dynamics may provide complementary information about brain state and cerebrovascular physiology during these high-risk operations. However, the relationships between monitor-derived features and intraoperative events - including hypotension, anesthetic transitions, major surgical events, and postoperative outcomes - remain incompletely characterized. DESIGN: Single-center prospective observational cohort study at UT Southwestern Medical Center. SedLine quantitative EEG data are extracted from standard-of-care clinical monitoring for all enrolled subjects. Brain4Care (B4C) noninvasive intracranial dynamics monitoring may additionally be placed as a research device depending on study workflow, patient characteristics, technical feasibility, and clinical context. Either monitoring configuration - SedLine alone or SedLine combined with B4C - constitutes a complete and valid study encounter. The Moberg Clinical Platform (Moberg Analytics; FDA-cleared multimodal data integration system) serves as the primary data acquisition hub where deployed in the operating room, aggregating synchronized high-resolution physiologic waveforms alongside SedLine and B4C outputs. Where Moberg is unavailable, hemodynamic and physiologic variables are collected retrospectively from the Epic intraoperative anesthesia record. MONITORING MODALITIES: Research device placed specifically for this study (where deployed): \- Brain4Care (B4C) extensometry: skull-mounted noninvasive sensor recording cranial compliance-related waveform morphology (P2/P1 ratio, Time to Peak). Standard-of-care clinical data recorded for research purposes: * SedLine (Masimo): 4-channel frontal quantitative EEG providing Patient State Index, Spectral Edge Frequency, and exportable raw EDF-format waveforms. * Moberg Clinical Platform: multimodal physiologic waveform integration including arterial blood pressure, SpO2, ECG, ventilator-derived parameters, temperature, and EtCO2. DATA MANAGEMENT: Subjects are assigned unique study identifiers. Direct identifiers are removed from analytic datasets. Research data are stored on secure, institutionally approved systems accessible only to IRB-authorized study personnel. De-identified data may be shared with qualified external collaborators under executed data use agreements.
Interventions
None listed
Sponsors
University of Texas Southwestern Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of enrolled cases with analyzable SedLine quantitative EEG (Patient State Index) recording during surgery | Intraoperative period (duration of surgery, typically 2-12 hours) | 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 | Intraoperative period (duration of surgery, typically 2-12 hours) | 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 | Intraoperative period through 90 days post-surgery | 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 | Intraoperative period through 90 days post-surgery | 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative delirium assessed by Confusion Assessment Method (CAM) | In-hospital postoperative period (expected 2-14 days post-surgery) | 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 | Intraoperative period | 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 | 90 days post-surgery | 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). |
Countries
United States
Contacts
CONTACTNoah Jouett, DO, PhD
PRINCIPAL_INVESTIGATORNoah Jouett, DO, PhD
University of Texas Southwestern Medical Center
Outcome results
None listed