Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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)].

Exclusion Criteria

  • 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). - Acute or chronic neurologic deficit precluding CAM-ICU assessments - Inability to understand English - Bilateral Deafness - Blindness that will preclude delirium evaluation - Current enrollment in a study that does not allow co-enrollment - Inability to obtain informed consent - Attending physician refusal - Patient and/or surrogate refusal - Patient unable to consent and no surrogate available - Prisoners

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Prospective Ceribell Delirium Monitoring Enrolled patients will undergo EEG monitoring with the Ceribell EEG System twice daily for up to 7 days.
  • Device: Ceribell EEG System
    EEG will be recorded with the Ceribell EEG System, including headband and recorder.

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37232
Contact:
Anya Harden
615-936-7355
anya.e.harden@vumc.org

More Details

Status
Recruiting
Sponsor
Ceribell Inc.

Study Contact

Michelle Hofmann, MSN
908-892-1193
michelle.hofmann@ceribell.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.