RecruitingNCT04962815

Ceribell Delirium Data Collection Study


Sponsor

Ceribell Inc.

Enrollment

200 participants

Start Date

Nov 10, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria3

  • 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

Exclusion Criteria1

  • \- Any condition that prevents use of the Ceribell EEG system on the subject for the entire anticipated EEG monitoring period. Examples may include: Craniectomy with missing bone flap in an area where Ceribell EEG electrodes are placed. Expected use of continuous clinical EEG for the entire anticipated monitoring period.

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Interventions

DEVICEElectroencephalogram (EEG) Test

EEG test and delirium assessments will be performed on subjects experiencing delirium in the ICU.


Locations(7)

Stanford University

Stanford, California, United States

Naples Community Hospital

Naples, Florida, United States

University of Iowa Hospitals & Clinics

Iowa City, Iowa, United States

Mercy

St Louis, Missouri, United States

Cooper Health

Camden, New Jersey, United States

UNC Health Rex

Raleigh, North Carolina, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

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NCT04962815


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