About this trial
This is a prospective observational cohort study of adult patients admitted to the Neurosciences Intensive Care Unit (NSICU) at UT Southwestern Medical Center. The study acquires multimodal neuromonitoring data - including SedLine quantitative EEG (qEEG) from standard-of-care monitoring, Brain4Care (B4C) noninvasive intracranial dynamics monitoring, and near-infrared spectroscopy (NIRS)-derived cerebral autoregulation (CA) indices where NIRS is already in clinical use - and links these data to bedside physiologic, medication, diagnostic, and clinical outcome variables during standard care. No alteration of clinical management occurs. The study prioritizes aneurysmal subarachnoid hemorrhage (aSAH) patients to characterize the natural history of noninvasive CA parameter evolution through the delayed cerebral ischemia (DCI) window (admission through Day 14) and provides preliminary data for subsequent interventional study design.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older
Admitted to the NSICU at UT Southwestern Medical Center
Informed consent obtained from subject or legally authorized representative (as defined under Texas Health and Safety Code Section 166.039), or consent process underway per institutional policy
At least one study monitoring modality feasible (SedLine qEEG and/or Brain4Care extensometry); NIRS data collected where already in standard clinical use
Disqualifiers
Age younger than 18 years
Prisoner status
Active declination of participation by subject or legally authorized representative
Absence of both subject and legally authorized representative consent when required
Trial population
Adult patients age 18 years or older admitted to the Neurosciences Intensive Care Unit (NSICU) at UT Southwestern Medical Center. The population is intentionally broad to support observational analyses across common neurocritical care diagnoses. aSAH patients are a priority enrollment group given the scientific objectives related to characterizing the natural history of noninvasive CA parameter evolution through the DCI window.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Proportion of enrolled participants with analyzable Brain4Care extensometry (P2/P1 ratio) recording across NSICU diagnoses
Percentage of enrolled participants with at least one successful Brain4Care (B4C) extensometry monitoring session yielding analyzable P2/P1 ratio data. Signal quality assessed by artifact burden and adequate waveform morphology. Reported as a single proportion compared across primary NSICU diagnostic groups (aSAH, TBI, ICH, stroke, other).
Proportion of Brain4Care extensometry sessions with computable cerebral autoregulation indices (nPRx) across NSICU diagnoses
Percentage of Brain4Care (B4C) extensometry monitoring sessions from which the noninvasive pressure reactivity index (nPRx) can be computed from B4C waveforms and concurrent arterial blood pressure data. Reported as a single proportion compared across primary NSICU diagnostic groups (aSAH, TBI, ICH, stroke, other).
NIRS-derived cerebral oximetry index (COx) trajectory through the delayed cerebral ischemia window in aSAH
Prospective characterization of near-infrared spectroscopy (NIRS)-derived cerebral oximetry index (COx; unitless, range -1 to +1) trajectory from NSICU admission through Day 14 in aSAH patients. Correlation of COx trajectory with DCI onset (clinical and imaging-confirmed) and neurological outcome at discharge, reported as Spearman correlation coefficients.
NIRS-derived optimal mean arterial pressure (MAPopt) trajectory through the delayed cerebral ischemia window in aSAH
Prospective characterization of near-infrared spectroscopy (NIRS)-derived optimal mean arterial pressure (MAPopt; reported in mmHg) trajectory from NSICU admission through Day 14 in aSAH patients. Correlation of MAPopt trajectory with DCI onset (clinical and imaging-confirmed) and neurological outcome at discharge, reported as Spearman correlation coefficients.
Secondary outcomes
SedLine Patient State Index values in relation to sedation exposure and clinical neurological status
Characterization of SedLine-derived Patient State Index (PSI; unitless, range 0-100) in relation to sedative medication exposure, clinical neurological status, primary NSICU diagnosis, and neurological outcome at discharge. PSI values reported as median with interquartile range stratified by sedation state and diagnostic group.
SedLine Spectral Edge Frequency values in relation to sedation exposure and clinical neurological status
Characterization of SedLine-derived Spectral Edge Frequency (SEF95; reported in Hz) in relation to sedative medication exposure, clinical neurological status, primary NSICU diagnosis, and neurological outcome at discharge. SEF95 values reported as median with interquartile range stratified by sedation state and diagnostic group.
Proportion of Brain4Care extensometry monitoring sessions successfully completed across NSICU clinical care states
Percentage of Brain4Care (B4C) extensometry monitoring sessions successfully completed, reported as a single proportion stratified by clinical care state (intubated/ventilated vs. extubated; sedated vs. awake; EVD present vs. absent). Duration of analyzable monitoring epochs reported in hours. Proportion of patients with multi-session longitudinal data reported as percentage.
Correlation between transcranial Doppler (TCD) mean flow velocity and Brain4Care-derived noninvasive pressure reactivity index (nPRx) in aSAH
Spearman correlation coefficient between daily transcranial Doppler (TCD)-derived mean flow velocity (cm/s) and concurrently computed Brain4Care (B4C)-derived noninvasive pressure reactivity index (nPRx) in aSAH patients. Temporal association between TCD-defined vasospasm severity (Lindegaard ratio) and nPRx deterioration characterized as time-lagged cross-correlation.
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