NCT07449416NARecruiting
Ceribell Delirium Monitor Outcomes Pilot Study
Ceribell Inc.
Start Date
3/15/2026
Completion Date
12/1/2026
Summary
This pilot study is designed as a pre- and post-delirium monitor cohort study, with a prospective intervention cohort and a retrospective control cohort.
Detailed Description
The purpose of this non-powered pilot study is to assess the feasibility of adding the Ceribell Delirium Monitor to the standard of care delirium assessment and management workflow, identify potential differences in patient outcomes between the control and intervention cohorts, and inform the design of a future randomized controlled trial.
Eligibility Criteria
Age Range: 18 years to No maximum
Inclusion Criteria:
* 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
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.
* 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
Interventions
DEVICE
Ceribell Delirium Monitoring System
Conditions
Delirium in the Intensive Care Unit
Locations
University of California Irvine
Irvine, California 92697
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15261
United States