Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit.
E Wesley Ely, Ayumi Shintani, Brenda Truman...
https://pubmed.ncbi.nlm.nih.gov/15082703Actively Recruiting
Age: 18Years +
All Genders
ID04962815
Ceribell Delirium Data Collection Study
Led by Ceribell Inc. · Updated on 2025-07-25
200
Participants Needed
7
Research Sites
13 weeks
Total Duration
On this page
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
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age is 18 years or older
- Admitted to the Intensive Care Unit (ICU)
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
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
Trial Site Locations
Total: 7 locations
1
Stanford University
Stanford, California, United States, 94305
Active, Not Recruiting
2
Naples Community Hospital
Naples, Florida, United States, 34102
Active, Not Recruiting
3
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States, 52242
Active, Not Recruiting
4
Mercy
St Louis, Missouri, United States, 63141
Active, Not Recruiting
5
Cooper Health
Camden, New Jersey, United States, 08103
Active, Not Recruiting
6
UNC Health Rex
Raleigh, North Carolina, United States, 27607
Active, Not Recruiting
7
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
Loading map...
Research Team
M
Michelle Hofmann, MSN
J
Jessy Dorn, PhD
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Prevalence and risk factors for development of delirium in surgical and trauma intensive care unit patients.
Pratik Pandharipande, Bryan A Cotton, Ayumi Shintani...
https://pubmed.ncbi.nlm.nih.gov/18580517Delirium in the cardiovascular ICU: exploring modifiable risk factors.
John A McPherson, Chad E Wagner, Leanne M Boehm...
https://pubmed.ncbi.nlm.nih.gov/23263581Acute Brain Failure: Pathophysiology, Diagnosis, Management, and Sequelae of Delirium.
José R Maldonado
https://pubmed.ncbi.nlm.nih.gov/28601132The Confusion Assessment Method for the ICU-7 Delirium Severity Scale: A Novel Delirium Severity Instrument for Use in the ICU.
Babar A Khan, Anthony J Perkins, Sujuan Gao...
https://pubmed.ncbi.nlm.nih.gov/28263192Delirium detection in older acute medical inpatients: a multicentre prospective comparative diagnostic test accuracy study of the 4AT and the confusion assessment method.
Susan D Shenkin, Christopher Fox, Mary Godfrey...
https://pubmed.ncbi.nlm.nih.gov/31337404New horizons in the pathogenesis, assessment and management of delirium.
Alasdair M J Maclullich, Atul Anand, Daniel H J Davis...
https://pubmed.ncbi.nlm.nih.gov/24067500The neuropsychology of delirium: advancing the science of delirium assessment.
Zoë Tieges, Jonathan J Evans, Karin J Neufeld...
https://pubmed.ncbi.nlm.nih.gov/28393426Evaluation of delirium in critically ill patients: validation of the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU).
E W Ely, R Margolin, J Francis...
https://pubmed.ncbi.nlm.nih.gov/11445689The EEG in metabolic encephalopathy and coma.
Peter W Kaplan
https://pubmed.ncbi.nlm.nih.gov/15592005