Ceribell Delirium Data Collection Study
ConditionDelirium
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCeribell Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial population
Subjects who experience at least one delirious episode during their ICU stay
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Electroencephalogram (EEG) Test
DeviceEEG test and delirium assessments will be performed on subjects experiencing delirium in the ICU.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Perform Confusion Assessment Method for the ICU (CAM-ICU) assessment
Research coordinator will perform and collect CAM-ICU assessment data on study subjects
Time frame
3 times per day, for a maximum of six (6) days2
Perform Electroencephalogram (EEG) Test
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.
Time frame
6-8 hours per day, for a maximum of six (6) daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov