Prospective Observational Multimodal Neuromonitoring During High-Risk Adult Surgery

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT07577726
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Jul 31, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Proportion of enrolled cases with analyzable SedLine quantitative EEG (Patient State Index) recording during surgery [ Time Frame: Intraoperative period (duration of surgery, typically 2-12 hours) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UT Southwestern Medical Center - Clements University HospitalDallasTexas75390
Noah Jouett, DO, PhD
[email protected]
2147862783
Noah Jouett, DO, PhD (PRINCIPAL_INVESTIGATOR)
Ulrike Hoffmann, MD, PhD (SUB_INVESTIGATOR)
Peiman Lahsaei, MD (SUB_INVESTIGATOR)

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By research site
UT Southwestern Medical Center - Clements University Hospital· Dallas, TX

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