Ceribell Delirium Monitor Outcomes Pilot Study

Ceribell Delirium Monitor Outcomes Pilot 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.

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.

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