Delirium in the Intensive Care Unit
Conditions
Keywords
Delirium, Delirium Monitoring, Ceribell, Electroencephalogram (EEG)
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.
Interventions
DEVICECeribell 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.
Sponsors
Ceribell Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Intervention model description
Pilot, multi-center, prospective, interventional, retrospective control
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants with Delirium Diagnosed Outside Routine Standard-of-Care Assessments | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in Delirium-Directed Management | From ICU admission to ICU discharge (up to 7 days) | 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. |
Countries
United States
Contacts
CONTACTMichelle Hofmann, MSN
CONTACTAlexandra C. Fietsam, PhD
Outcome results
None listed