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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
100
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.
University of California Irvine
Irvine, California, United States
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)
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