This study is not yet accepting patients

Ceribell Delirium Monitor Outcomes Pilot Study

a study on Delirium in the Intensive Care Unit

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Irvine, California
Dates
study started
study ends around
Principal Investigator
by Yama Akbari, MD, PhD

Description

Summary

This pilot study is designed as a pre- and post-delirium monitor cohort study, with a prospective intervention cohort and a retrospective control cohort.

Details

The purpose of this non-powered pilot study is to assess the feasibility of adding the Ceribell Delirium Monitor to the standard of care delirium assessment and management workflow, identify potential differences in patient outcomes between the control and intervention cohorts, and inform the design of a future randomized controlled trial.

Keywords

Delirium in the Intensive Care Unit, Delirium, Delirium Monitoring, Ceribell, Electroencephalogram (EEG), Ceribell Delirium Monitoring System, Prospective Ceribell Delirium Monitoring

Eligibility

You can join if…

Open to people ages 18 years and up

  • Age is 18 years or older
  • Admitted to the ICU for an expected duration ≥ 24 hours from enrollment
  • Have at least one of the following conditions:

Acute Sepsis or Septic Shock Admitted to the ICU following elective cardiothoracic surgery Acute respiratory failure requiring non-invasive ventilation or high-flow nasal cannula (HFNC) oxygenation Shock requiring vasopressor therapy Mechanically ventilated - Current RASS ≥ -3 and not expected to require deep sedation (RASS < -3) during the ICU stay

You CAN'T join if...

  • 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.

  • Baseline neurological dysfunction (Glasgow Coma Scale < 10) and pre-existing brain injuries such as stroke with known deficits, severe TBI
  • History of moderate-severe dementia (IQCODE ≥ 3.5)
  • APACHE II score > 30, or SOFA > 9 at enrollment

Location

  • University of California Irvine
    Irvine California 92697 United States

Lead Scientist at UC Irvine

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Ceribell Inc.
ID
NCT07449416
Study Type
Interventional
Participants
Expecting 100 study participants
Last Updated