Ceribell EEG monitoring for adults in the ICU at high risk of delirium

EEG Abnormalities in Adult ICU Patients With High Risk of Delirium

This project will test whether a portable Ceribell EEG can detect abnormal brain activity in adult medical, surgical, and cardiovascular ICU patients at high risk for delirium.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ceribell Inc. (Industry-sponsored)
• Locations: 1 site (Nashville, Tennessee)
• Trial ID: NCT07485244 on ClinicalTrials.gov

What this trial studies

This is an observational study that uses the Ceribell point-of-care EEG system to record EEG activity in adult ICU patients judged to be at high risk for delirium. Eligible patients are adults admitted to medical, surgical, or cardiovascular ICUs with an expected stay of at least 24 hours who are receiving support for shock or respiratory failure. Patients with structural head conditions preventing electrode placement, those already receiving continuous EEG for other clinical purposes, or those with prolonged prior mechanical ventilation are excluded. The primary goal is to measure how often EEG abnormalities are present in this high-risk ICU population and describe the recorded patterns.

Who should consider this trial

Good fit: Adults aged 18 or older admitted to a medical, surgical, or cardiovascular ICU for an expected ≥24 hours who are receiving treatment for shock (e.g., vasopressors, IABP, or ECMO) and/or respiratory support (mechanical ventilation or NIPPV), and who have no structural head issues that would prevent Ceribell electrode placement.

Not a fit: Patients with skull defects or implanted devices that block Ceribell electrode placement, those already on continuous EEG for other clinical reasons, and patients ventilated >72 hours during the current hospitalization are unlikely to be eligible or to benefit from this monitoring approach.

Why it matters

Potential benefit: If successful, routine point-of-care EEG monitoring could help clinicians detect abnormal brain activity earlier and prompt interventions that may reduce delirium-related complications.

How similar studies have performed: Portable EEG systems like Ceribell have shown promise for detecting seizures and abnormal EEG patterns in ICU patients, but using point-of-care EEG specifically to screen high-risk patients for delirium is less well-established.

Eligibility criteria

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

Where this trial is running

Nashville, Tennessee

• Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)

Study contacts

• Study coordinator: Michelle Hofmann, MSN

Conditions Delirium in the Intensive Care Unit; Ceribell; Electroencephalogram; Delirium monitoring; Delirium