Prospective Observational Multimodal Neuromonitoring During High-Risk Adult Surgery
Starting soon
Conditions studied: Postoperative Cognitive Complications, Delirium, Perioperative/Postoperative Complications, Brain Injuries, Anesthesia
In brief
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 facts
- Study ID
- NCT07577726
- Run by
- University of Texas Southwestern Medical Center
- People needed
- 300
- Starts
- 2026-07-01
- Expected to finish
- 2028-12-01
- Last updated by the study team
- 2026-05-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- UT Southwestern Medical Center - Clements University Hospital — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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