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Observational Study on Brain Monitoring During High-Risk Surgery

This study is looking at how the brain responds during major surgeries like spine surgery, liver transplants, and heart surgery. Researchers will use two types of brain monitoring, SedLine (a quantitative electroencephalogram or qEEG, which measures brain electrical activity) and Brain4Care (which measures non-invasive brain dynamics), to collect information during your surgery. They will also collect other routine information about your health, medications, and recovery. The goal is to understand how these brain monitoring measurements relate to your health during and after surgery, and to create a dataset for future research on brain health in patients undergoing high-risk procedures. You would be eligible if you are 18 or older and scheduled for one of these major surgeries at UT Southwestern Medical Center. The study is currently unclear on its recruitment status.

Study design
This is a single-center observational study at UT Southwestern Medical Center, planning to enroll 300 adult patients. It is not a randomized study and does not involve new treatments.
What's involved
Your routine clinical care will not be altered. The study involves collecting data from standard-of-care brain monitoring during your surgery, and potentially additional non-invasive brain monitoring if feasible.
Compensation
Not stated in the trial record.
Follow-up
Researchers will collect data during surgery and for up to 90 days after surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07577726

Prospective Observational Multimodal Neuromonitoring During High-Risk Adult Surgery

Not Yet Recruiting
Not specifiedAges 18+Observational
University of Texas Southwestern Medical Center
~300 participants
Updated 2026-05-11 on ClinicalTrials.gov

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of enrolled cases with analyzable SedLine quantitative EEG (Patient State Index) recording during surgery
Measured over Intraoperative period (duration of surgery, typically 2-12 hours)
+3 more outcomes measured

Conditions

Postoperative Cognitive Complications
Delirium
Perioperative/Postoperative Complications
Brain Injuries
Anesthesia

Explore related trials

Abdominal SurgeryBrain InjuryCardiac SurgeryCraniotomyDeliriumLiver TransplantationPostoperative cognitive dysfunctionSpine SurgeryThoracic Surgical ProcedureVascular Surgical Procedure

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Noah Jouett, DO, PhD · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center

Who to contact

Noah Jouett, DO, PhD
[email protected]
2147862783
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Proportion of enrolled cases with analyzable SedLine quantitative EEG (Patient State Index) recording during surgeryIntraoperative period (duration of surgery, typically 2-12 hours)

    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.

  • Proportion of enrolled cases with analyzable Brain4Care extensometry (P2/P1 ratio) recording during surgeryIntraoperative period (duration of surgery, typically 2-12 hours)

    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.

  • Correlation between SedLine Patient State Index and intraoperative mean arterial pressureIntraoperative period through 90 days post-surgery

    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.

  • Correlation between Brain4Care extensometry P2/P1 ratio and intraoperative mean arterial pressureIntraoperative period through 90 days post-surgery

    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.