RecruitingNCT07485244

EEG Abnormalities in Adult ICU Patients With High Risk of Delirium


Sponsor

Ceribell Inc.

Enrollment

100 participants

Start Date

Apr 16, 2026

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria14

  • 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

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Interventions

DEVICECeribell EEG System

EEG will be recorded with the Ceribell EEG System, including headband and recorder.


Locations(1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States

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NCT07485244


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