Brain monitors track hidden dangers during major surgery
NCT ID NCT07577726
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study watches brain activity in 300 adults during high-risk surgeries like heart or spine operations. Researchers use special monitors to track brain waves and pressure, linking them to patient outcomes. The goal is to understand why some people develop confusion or brain injury after surgery, but no treatments are tested here.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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UT Southwestern Medical Center - Clements University Hospital
Dallas, Texas, 75390, United States
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