Ceribell Delirium Monitor Outcomes Pilot Study
ConditionDelirium in the Intensive Care Unit
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCeribell Inc.
About this trial
This pilot study is designed as a pre- and post-delirium monitor cohort study, with a prospective intervention cohort and a retrospective control cohort.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age is 18 years or older
Admitted to the ICU for an expected duration ≥ 24 hours from enrollment
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Ceribell Delirium Monitoring System
DeviceThe 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Prospective Ceribell Delirium MonitoringExperimental treatment 1 intervention
Group B: Retrospective ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
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)Sponsors and contacts
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Source ClinicalTrials.gov