Prospective Observational Multimodal Neuromonitoring in Adult NSICU Patients

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Texas Southwestern Medical Center

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

300 Participants
are grouped into 1 trial group
Group A: Adult NSICU Patients

Trial outcomes

Primary outcomes

1

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).

Time frame
Through ICU Day 14 or hospital discharge, whichever occurs first
2

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).

Time frame
Through ICU Day 14 or hospital discharge, whichever occurs first
3

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.

Time frame
ICU admission through Day 14 post-rupture
4

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.

Time frame
ICU admission through Day 14 post-rupture

Secondary outcomes

1

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.

Time frame
Duration of ICU stay (expected 7-21 days for aSAH; varies by diagnosis)
2

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.

Time frame
Duration of ICU stay (expected 7-21 days for aSAH; varies by diagnosis)
3

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.

Time frame
Through ICU Day 14 or hospital discharge
4

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.

Time frame
ICU Day 1 through Day 14

Other outcomes

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