Prospective Observational Multimodal Neuromonitoring During High-Risk Adult Surgery (NCT07577726) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Prospective Observational Multimodal Neuromonitoring During High-Risk Adult Surgery
United States300 participantsStarted 2026-07
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of enrolled cases with analyzable SedLine quantitative EEG (Patient State Index) recording during surgery
Timeframe: Intraoperative period (duration of surgery, typically 2-12 hours)
2
Proportion of enrolled cases with analyzable Brain4Care extensometry (P2/P1 ratio) recording during surgery
Timeframe: Intraoperative period (duration of surgery, typically 2-12 hours)
3
Correlation between SedLine Patient State Index and intraoperative mean arterial pressure
Timeframe: Intraoperative period through 90 days post-surgery
4
Correlation between Brain4Care extensometry P2/P1 ratio and intraoperative mean arterial pressure
Timeframe: Intraoperative period through 90 days post-surgery
Trial details
NCT IDNCT07577726
SponsorUniversity of Texas Southwestern Medical Center