Ceribell Delirium Monitor Outcomes Pilot Study
Recruiting now · Not applicable
Conditions studied: Delirium in the Intensive Care Unit
In brief
This pilot study is designed as a pre- and post-delirium monitor cohort study, with a prospective intervention cohort and a retrospective control cohort.
Key facts
- Study ID
- NCT07449416
- Run by
- Ceribell Inc.
- People needed
- 100
- Starts
- 2026-03-15
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-07-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age is 18 years or older
- Admitted to the ICU for an expected duration ≥ 24 hours from enrollment
- Have at least one of the following conditions:
- Acute Sepsis or Septic Shock Admitted to the ICU following elective cardiothoracic surgery Acute respiratory failure requiring non-invasive ventilation or high-flow nasal cannula (HFNC) oxygenation Shock requiring vasopressor therapy Mechanically ventilated - Current RASS ≥ -3 and not expected to require deep sedation (RASS < -3) during the ICU stay
You may not qualify 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.
- Baseline neurological dysfunction (Glasgow Coma Scale < 10) and pre-existing brain injuries such as stroke with known deficits, severe TBI
- History of moderate-severe dementia (IQCODE ≥ 3.5)
- APACHE II score > 30, or SOFA > 9 at enrollment
Where it is running
- University of California Irvine — Irvine, California, United States (enrolling)
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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