Prospective Observational Multimodal Neuromonitoring During High-Risk Adult Surgery

NCT07577726 | Not Yet Recruiting

• 1 other identifier: STU20260828
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Cognitive Complications; Delirium; Perioperative/Postoperative Complications; Brain Injuries; Anesthesia

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

Outcome Measures

Primary Outcomes (4)

• 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.

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

• 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.

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

• 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.

  Intraoperative period through 90 days post-surgery

• 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.

  Intraoperative period through 90 days post-surgery

Secondary Outcomes (3)

• Incidence of postoperative delirium assessed by Confusion Assessment Method (CAM)

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

• Proportion of cases with computable cerebrovascular reactivity indices from Brain4Care extensometry and arterial blood pressure data

  Intraoperative period

• Functional status at 90 days post-surgery assessed by modified Rankin Scale via medical record review

  90 days post-surgery

Study Arms (1)

High-Risk Surgical Patients

Adult patients age 18 years or older undergoing 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. All participants undergo SedLine qEEG data capture from existing standard-of-care clinical monitoring. A subset additionally undergo B4C noninvasive intracranial dynamics monitoring as a research device.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center - Clements University Hospital

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Postoperative Cognitive Complications; Delirium; Postoperative Complications; Brain Injuries; Emergence Delirium

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Noah Jouett, DO, PhD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Noah Jouett, DO, PhD

CONTACT

2147862783; Noah.Jouett@UTSouthwestern.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Department of Anesthesiology and Pain Management

Study Record Dates

• First Submitted: April 18, 2026
• First Posted: May 11, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 11, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)