EEG Abnormalities in Adult ICU Patients With High Risk of Delirium
ConditionDelirium in the Intensive Care Unit
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCeribell Inc.
About this trial
The purpose of this study is to assess the prevalence of EEG abnormalities on Ceribell POC EEG in adult medical, surgical, and cardiovascular ICU patients with high risk of delirium
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patient ≥18 years old
Requiring admission to a medical, surgical and/or cardiovascular ICU for an expected duration ≥ 24 hours
Receiving treatment for shock (e.g., with vasopressors, intra-aortic balloon pump, or Extracorporeal Membrane Oxygenation therapy) and/or respiratory failure [e.g., on mechanical ventilation or non-invasive positive pressure ventilation (NIPPV)].
Disqualifiers
Any structural abnormality or head condition, including the presence of a device, that would prevent the use of the Ceribell EEG system for the entire anticipated EEG monitoring period. Examples include: Craniectomy with a missing bone flap in a region where Ceribell EEG electrodes would be placed.
Anticipated use of continuous EEG for a purpose other than delirium detection during the entire expected monitoring period.
Patients who have been on mechanical ventilation for >72 hours within the current hospitalization or who are on long-term ventilator support prior to the injury that resulted in the current hospitalization.
Expected death within 12 hours of enrollment or lack of commitment to treatment by family or the medical team (e.g., likely to withdraw life support measures within 12 hours of enrollment).
Trial population
Adult ICU patients with high risk of delirium
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Ceribell EEG System
DeviceEEG will be recorded with the Ceribell EEG System, including headband and recorder.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Prospective Ceribell Delirium Monitoring1 intervention
Trial outcomes
Primary outcomes
1
Prevalence of EEG Abnormalities on the Ceribell EEG System
Prevalence of EEG abnormalities, including epileptiform and ictal-interictal continuum (IIC) patterns, recorded on the Ceribell EEG System
Time frame
Starting baseline through study completion, up to 1 year.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Ceribell Inc.
Lead sponsor
Vanderbilt University Medical Center
Collaborator
Source ClinicalTrials.gov