Ceribell Monitoring for Delirium
(DOM Trial)
What You Need to Know Before You Apply
What is the purpose of 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.
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Prospective Ceribell Delirium Monitoring
ICU patients undergo up to 12 hours of continuous EEG recording with the Ceribell Delirium Monitor for up to 7 days. Delirium Trend Reports are presented during morning rounds.
Retrospective Control
Data on delirium management and patient clinical outcomes are collected from chart review for patients in the retrospective control arm.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Ceribell Delirium Monitoring System
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ceribell Inc.
Lead Sponsor
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