Ceribell Delirium Monitor Outcomes Pilot Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ceribell Delirium Monitoring System.
- Who it may be relevant to
- Registry conditions: Delirium in the Intensive Care Unit. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device Ceribell Delirium Monitoring System
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.
Primary outcome measures
- Proportion of Participants with Delirium Diagnosed Outside Routine Standard-of-Care Assessments [Time frame: From ICU admission to ICU discharge (up to 7 days)]
Secondary outcome measures (1)
- Changes in Delirium-Directed Management [Time frame: From ICU admission to ICU discharge (up to 7 days)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Screening
Study locations
United States · 2 centers
- University of California Irvine — Irvine
- University of Pittsburgh Medical Center — Pittsburgh
Identifiers
NCT: NCT07449416 · 2025-01-P