Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07485244

EEG Abnormalities in Adult ICU Patients With High Risk of Delirium

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location status: Recruiting

Location contact

Anya Harden

CONTACT

[email protected]

615-936-7355

Wesley Ely, MD, MPH

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ceribell EEG System

Device

EEG will be recorded with the Ceribell EEG System, including headband and recorder.

Primary outcomes

  1. Prevalence of EEG Abnormalities on the Ceribell EEG System

    Time frame: Starting baseline through study completion, up to 1 year.

    Prevalence of EEG abnormalities, including epileptiform and ictal-interictal continuum (IIC) patterns, recorded on the Ceribell EEG System

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandra C. Fietsam, PhD

CONTACT

[email protected]

5632091704

Michelle Hofmann, MSN

CONTACT

[email protected]

908-892-1193

Sponsors and collaborators

Lead sponsor

Ceribell Inc.

Industry

Collaborators

  • Vanderbilt University Medical Center

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Mar 20, 2026
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.