Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
BACKGROUND: Patients admitted to the NSICU undergo rapid physiologic changes related to primary neurologic injury, secondary brain injury, sedation, mechanical ventilation, and evolving systemic illness. Cerebral autoregulation (CA) - the brain's intrinsic mechanism for maintaining stable perfusion across a range of systemic arterial pressures - is measurably impaired in aSAH, traumatic brain injury (TBI), intracerebral hemorrhage (ICH), and acute ischemic stroke. In aSAH, CA impairment during the 4-14 day post-rupture window is independently associated with delayed cerebral ischemia (DCI), the leading cause of preventable death and disability in survivors. Approximately 75% of aSAH patients require an external ventricular drain (EVD), which prevents standard ICP-based CA monitoring. B4C extensometry and NIRS-derived CA indices offer EVD-independent monitoring approaches whose feasibility and signal characteristics in aSAH have not been prospectively described.
DESIGN: Single-center prospective observational cohort study at the UT Southwestern NSICU. Eligible subjects may undergo B4C extensometry monitoring (the sole research-specific device under this protocol) and/or have research data recorded from existing standard-of-care clinical monitoring including SedLine qEEG, full-montage long-term monitoring EEG (where clinically ordered), NIRS, invasive ICP/CPP from EVD monitors, transcranial Doppler (TCD; standard of care for aSAH at UT Southwestern), and NeurOptics NPi automated pupillometry. The Moberg Clinical Platform (Moberg Analytics; FDA-cleared) serves as the primary data acquisition hub in the NSICU, aggregating synchronized high-resolution physiologic waveforms from existing bedside monitors without placing any additional research devices.
MONITORING MODALITIES:
Research device placed specifically for research purposes under this protocol:
- Brain4Care (B4C) extensometry: skull-mounted noninvasive sensor recording cranial compliance-related waveform morphology (P2/P1 ratio, Time to Peak), from which surrogate CA indices (nPRx, nCPPopt, nMx) are derived.
Standard-of-care clinical data recorded for research purposes (no additional devices placed):
ASAH PRIORITY ENROLLMENT: For aSAH patients, the protocol prioritizes monitoring through ICU Day 14 to characterize the natural history of B4C-derived and NIRS-derived CA index evolution through the DCI window. An optional 90-day follow-up captures functional and neurological outcomes beyond hospital discharge.
DATA MANAGEMENT: Subjects are assigned unique study identifiers. Direct identifiers are removed from analytic datasets. De-identified data may be shared with qualified external collaborators under executed data use agreements and with applicable IRB approval. De-identified data from this study may be combined with data from the companion NSICU Autonomic Modulation Study for analyses within the approved scope of both protocols.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult NSICU Patients | Adult patients age 18 years or older admitted to the NSICU at UT Southwestern Medical Center. Diagnostic groups include but are not limited to aneurysmal subarachnoid hemorrhage, traumatic brain injury, intracerebral hemorrhage, acute ischemic stroke, seizure-related presentations, postoperative neurosurgical patients, disorders of consciousness, and encephalopathy. aSAH patients represent the priority enrollment group. All participants have at least one monitoring modality acquired: B4C extensometry placed by study personnel, and/or research data recorded from existing standard-of-care SedLine, NIRS, TCD, or long-term monitoring EEG monitoring. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Through ICU Day 14 or hospital discharge, whichever occurs first |
| 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). | Through ICU Day 14 or hospital discharge, whichever occurs first |
| 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. | ICU admission through Day 14 post-rupture |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Noah Jouett, DO, PhD | Contact | 2147862783 | Noah.Jouett@UTSouthwestern.edu |
| Name | Affiliation | Role |
|---|---|---|
| Noah Jouett, DO, PhD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Southwestern Medical Center - Clements University Hospital NSICU | Dallas | Texas | 75390 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ICU admission through Day 14 post-rupture |
| Duration of ICU stay (expected 7-21 days for aSAH; varies by diagnosis) |
| 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. | Duration of ICU stay (expected 7-21 days for aSAH; varies by diagnosis) |
| 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. | Through ICU Day 14 or hospital discharge |
| 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. | ICU Day 1 through Day 14 |
| Functional status at 90 days post-discharge 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 optional structured contact at 90 days. Reported as ordinal mRS score (0-6). This component is not required for protocol completion; omission does not constitute a protocol deviation. | 90 days post-hospital discharge |
| ID | Term |
|---|---|
| D013345 | Subarachnoid Hemorrhage |
| D000070642 | Brain Injuries, Traumatic |
| D002543 | Cerebral Hemorrhage |
| D000083242 | Ischemic Stroke |
| D055191 | Delayed Emergence from Anesthesia |
| D001927 | Brain Diseases |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001930 | Brain Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D020521 | Stroke |
| D011183 | Postoperative Complications |
Not provided
Not provided