An interventional study of Ceribell Delirium Monitoring System in Delirium in the Intensive Care Unit, sponsored by Ceribell Inc.. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by Ceribell Inc. · Not applicable, Interventional, and Screening
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.
933 studies on the registry are indexed under Delirium; 190 are open to participants now.
This study's planned enrollment of 100 is below the median of 112 across 550 interventional studies indexed under Delirium.
Browse Delirium studies →Ceribell Inc. is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
ICU patients who meet the inclusion and exclusion criteria will be enrolled. These patients will undergo up to 12 hours of continuous EEG recording with the Ceribell Delirum Monitor for up to 7 days. If delirium is detected, the study staff will perform CAM-ICU assessments to determine the presence of delirium. Additionally, a Delirium Trend Report will be presented to each patient's care team during morning rounds and any alterations in patient care will be documented.
Device: Ceribell Delirium Monitoring System
Patients who met the inclusion and exclusion criteria during their ICU stay will be enrolled in the retrospective control arm. Study staff will collect data on delirium management and patient clinical outcomes from chart review.
The Ceribell Delirium Monitor provides an assessment of delirium every 15 minutes during each EEG recording and provides a trend graph depicting the output of the algorithm. If delirium is detected, a CAM-ICU assessment will be performed to confirm the presence of delirium. The patient's care team will use the additional data provided by the Ceribell Delirium Monitor to inform decisions regarding alterations in the patient's delirium management.
Proportion of Participants with Delirium Diagnosed Outside Routine Standard-of-Care Assessments
Percentage of participants who receive at least one delirium diagnosis outside of routine morning and evening standard-of-care (SOC) assessments during the ICU stay.
Time frame: From ICU admission to ICU discharge (up to 7 days)
Changes in Delirium-Directed Management
Documented changes in pharmacologic or non-pharmacologic delirium-directed treatment or management per participant during the ICU stay. A change is defined as initiation, discontinuation, or dose adjustment of a delirium-directed medication, or implementation of a new non-pharmacologic delirium intervention.
Time frame: From ICU admission to ICU discharge (up to 7 days)
Plan to share: No
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