Ceribell Delirium Monitor Outcomes Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Proportion of Participants with Delirium Diagnosed Outside Routine Standard-of-Care Assessments
Study Overview
Brief 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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Prospective Ceribell Delirium Monitoring
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.
Intervention: Ceribell Delirium Monitoring System (Device)
Retrospective Control
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.
Outcomes
Primary Outcomes
Proportion of Participants with Delirium Diagnosed Outside Routine Standard-of-Care Assessments
Time Frame: From ICU admission to ICU discharge (up to 7 days)
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.
Secondary Outcomes
- Changes in Delirium-Directed Management(From ICU admission to ICU discharge (up to 7 days))