Prospective Observational Multimodal Neuromonitoring During High-Risk Adult Surgery

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 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 volunteers

Qualifiers

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

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: High-Risk Surgical Patients

Trial outcomes

Primary outcomes

1

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.

Time frame
Intraoperative period (duration of surgery, typically 2-12 hours)
2

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.

Time frame
Intraoperative period (duration of surgery, typically 2-12 hours)
3

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.

Time frame
Intraoperative period through 90 days post-surgery
4

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.

Time frame
Intraoperative period through 90 days post-surgery

Secondary outcomes

1

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.

Time frame
In-hospital postoperative period (expected 2-14 days post-surgery)
2

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.

Time frame
Intraoperative period
3

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).

Time frame
90 days post-surgery

Other outcomes

Sponsors and contacts

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