Ceribell Delirium Data Collection Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-10

Study Completion Date

2026-04-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Delirium

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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Electroencephalogram (EEG) Test

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

Intervention Type DEVICE

Other Intervention Names

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Delirium Assessments

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

\- 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jose Maldonado, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Timothy Girard, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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