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NCT07485244Recruiting

EEG Abnormalities in Adult ICU Patients With High Risk of Delirium

Ceribell Inc.

Start Date

4/16/2026

Completion Date

9/30/2027

Summary

The purpose of this study is to assess the prevalence of EEG abnormalities on Ceribell POC EEG in adult medical, surgical, and cardiovascular ICU patients with high risk of delirium

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Adult patient ≥18 years old * Requiring admission to a medical, surgical and/or cardiovascular ICU for an expected duration ≥ 24 hours * Receiving treatment for shock (e.g., with vasopressors, intra-aortic balloon pump, or Extracorporeal Membrane Oxygenation therapy) and/or respiratory failure \[e.g., on mechanical ventilation or non-invasive positive pressure ventilation (NIPPV)\]. Exclusion Criteria: * Any structural abnormality or head condition, including the presence of a device, that would prevent the use of the Ceribell EEG system for the entire anticipated EEG monitoring period. Examples include: Craniectomy with a missing bone flap in a region where Ceribell EEG electrodes would be placed. * Anticipated use of continuous EEG for a purpose other than delirium detection during the entire expected monitoring period. * Patients who have been on mechanical ventilation for \>72 hours within the current hospitalization or who are on long-term ventilator support prior to the injury that resulted in the current hospitalization. * Expected death within 12 hours of enrollment or lack of commitment to treatment by family or the medical team (e.g., likely to withdraw life support measures within 12 hours of enrollment). * Acute or chronic neurologic deficit precluding CAM-ICU assessments * Inability to understand English * Bilateral Deafness * Blindness that will preclude delirium evaluation * Current enrollment in a study that does not allow co-enrollment * Inability to obtain informed consent * Attending physician refusal * Patient and/or surrogate refusal * Patient unable to consent and no surrogate available * Prisoners

Interventions

DEVICE

Ceribell EEG System

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Conditions

Delirium in the Intensive Care Unit

Locations

Vanderbilt University Medical Center

Nashville, Tennessee 37232

United States