Observational Study Collecting EEG and Clinical Data to Monitor Delirium in ICU Patients Aged 18 and Older
Led by Ceribell Inc. · Updated on 2025-07-25
200
Participants Needed
7
Research Sites
13 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are conducting a prospective, non-randomized observational study to collect clinical and rapid response EEG Ceribell EEG data from patients in the Intensive Care Unit ICU who experience delirium. The goal is to gather information that will help develop future software tools to assess the presence and severity of different delirium subtypes. This study focuses on understanding delirium through detailed monitoring techniques.
Participants will undergo EEG testing using the Ceribell device and clinical delirium assessments while in the ICU. EEG tests will be performed for 6 to 8 hours per day, up to six days. Alongside EEG monitoring, the Confusion Assessment Method for the ICU CAM-ICU will be conducted three times daily for up to six days. These procedures are observational and aim to collect data rather than provide treatment.
During the study, participants will be closely monitored with regular EEG recordings and clinical assessments to track delirium symptoms. The study team will collect data on EEG patterns and delirium severity throughout the ICU stay. This data collection and monitoring will help researchers evaluate potential tools for future delirium assessment. Participation lasts as long as the monitoring period, up to six days, with no additional follow-up specified.
CONDITIONS
Brief Title
Ceribell Delirium Data Collection Study
Research Team
M
Michelle Hofmann, MSN
J
Jessy Dorn, PhD
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Fluent in the language used for delirium assessment
You will not qualify if you...
Any condition preventing use of the Ceribell EEG system during the entire monitoring period, such as a craniectomy with missing bone flap where electrodes are placed
Expected use of continuous clinical EEG for the entire monitoring period
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - Up to 6 days
Participants experience EEG testing and delirium assessments while in the ICU.
Daily assessments 3 times per day and EEG testing 6-8 hours per day
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Published Research Related To This Trial
Delirium detection in older acute medical inpatients: a multicentre prospective comparative diagnostic test accuracy study of the 4AT and the confusion assessment method.