Collecting data on delirium using EEG monitoring
Ceribell Delirium Data Collection Study
This study is trying to see how EEG monitoring can help track and understand different types of delirium in patients in the Intensive Care Unit.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ceribell Inc. Industry-sponsored |
| Locations | 7 sites (Stanford, California and 6 other locations) |
| Trial ID | NCT04962815 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather clinical and EEG data from patients in the Intensive Care Unit who are being monitored for different subtypes of delirium. By utilizing the Ceribell EEG system, the study will track the presence and severity of delirium in these patients. The collected data will contribute to the development of future software algorithms designed to enhance delirium assessment. The study is non-randomized and focuses on real-world clinical settings.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 years or older who are admitted to the Intensive Care Unit and can communicate in the language of the delirium assessment.
Not a fit: Patients with conditions that prevent the use of the Ceribell EEG system during the monitoring period will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved methods for diagnosing and managing delirium in critically ill patients.
How similar studies have performed: While this approach is observational and builds on existing EEG technology, similar studies have shown promise in improving delirium assessment and management.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: All must be present * Age is 18 years or older * Admitted to the Intensive Care Unit (ICU) * Subject must be fluent in the language in which the delirium assessment is performed Exclusion Criteria: All must be absent \- Any condition that prevents use of the Ceribell EEG system on the subject for the entire anticipated EEG monitoring period. Examples may include: Craniectomy with missing bone flap in an area where Ceribell EEG electrodes are placed. Expected use of continuous clinical EEG for the entire anticipated monitoring period.
Where this trial is running
Stanford, California and 6 other locations
- Stanford University — Stanford, California, United States (Active_not_recruiting)
- Naples Community Hospital — Naples, Florida, United States (Active_not_recruiting)
- University of Iowa Hospitals & Clinics — Iowa City, Iowa, United States (Active_not_recruiting)
- Mercy — St Louis, Missouri, United States (Active_not_recruiting)
- Cooper Health — Camden, New Jersey, United States (Active_not_recruiting)
- UNC Health Rex — Raleigh, North Carolina, United States (Active_not_recruiting)
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Jose Maldonado, MD — Stanford University
- Study coordinator: Michelle Hofmann, MSN
- Email: michelle.hofmann@ceribell.com
- Phone: 800-436-0826
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.