Delirium
Conditions
Keywords
delirium, EEG, Electroencephalogram
Brief summary
This study is designed as a prospective, non-randomized, observational clinical study. The study will collect clinical and rrEEG (Ceribell EEG) data when monitoring subjects for delirium subtypes. EEG and clinical data will be collected for the development of future software algorithms to assess the presence and severity of delirium.
Interventions
DEVICEElectroencephalogram (EEG) Test
EEG test and delirium assessments will be performed on subjects experiencing delirium in the ICU.
Sponsors
Ceribell Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perform Confusion Assessment Method for the ICU (CAM-ICU) assessment | 3 times per day, for a maximum of six (6) days | Research coordinator will perform and collect CAM-ICU assessment data on study subjects |
| Perform Electroencephalogram (EEG) Test | 6-8 hours per day, for a maximum of six (6) days | Record and collect EEG brain waves on study subjects using Ceribell Rapid Response EEG to assess multiple time-frequency EEG features to differentiate between delirium positive and delirium negative patients. |
Countries
United States
Contacts
Primary ContactMichelle Hofmann, MSN
Backup ContactJessy Dorn, PhD
Outcome results
None listed