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Ceribell Delirium Monitor Outcomes Pilot Study
Recruiting
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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
About the study
This pilot study is designed as a pre- and post-delirium monitor cohort study, with a prospective intervention cohort and a retrospective control cohort.
What is being tested
- Ceribell Delirium Monitoring System (device)
Sponsor: Ceribell Inc. · Participants: 100 · Started: Mar 15, 2026
Contact the study team
- Michelle Hofmann, MSN · Phone: 908-892-1193
- Alexandra C. Fietsam, PhD · Phone: 563-209-1704
Official record on ClinicalTrials.gov — NCT07449416
Locations in the U.S.
| California | University of California Irvine, Irvine |
| Pennsylvania | University of Pittsburgh Medical Center, Pittsburgh (Not yet recruiting) |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.