Delirium in the Intensive Care UnitDevice
What this study is
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
What's being tested
- Ceribell EEG System
Intervention · DEVICE
EEG will be recorded with the Ceribell EEG System, including headband and recorder.
Study details
- Sponsor
- Ceribell Inc.
- Conditions
- Delirium in the Intensive Care Unit
- Enrolling
- 100 people
- Starts
- 2026-03-23
- Est. completion
- 2027-09-30
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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)].
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openVanderbilt University Medical Center
Nashville, Tennessee, United States
- Anya Harden · Contact615-936-7355anya.e.harden@vumc.org
- Wesley Ely, MD, MPH · Principal investigator
Study team
Sponsor
Ceribell Inc.
Study ID 2025-02-P
Have questions? The contacts above can answer them before you apply.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.