Ceribell Delirium Monitor Outcomes Pilot Study (NCT07449416) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Ceribell Delirium Monitor Outcomes Pilot Study
United States100 participantsStarted 2026-03-15
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Proportion of Participants with Delirium Diagnosed Outside Routine Standard-of-Care Assessments
Timeframe: From ICU admission to ICU discharge (up to 7 days)