Ceribell Delirium Data Collection Study

Recruiting

• Conditions: Delirium

• Registration Number: NCT04962815
• Lead Sponsor: Ceribell Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-29
• Study First Submitted QC: 2021-07-13
• Study First Posted: 2021-07-15
• Study Start: 2021-11-10
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-22
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

All must be present

• 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

All must be absent

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Perform Electroencephalogram (EEG) Test	6-8 hours per day, for a maximum of six (6) days	Record and collect EEG brain waves on study subjects using Ceribell Rapid Response EEG to assess multiple time-frequency EEG features to differentiate between delirium positive and delirium negative patients.
Perform Confusion Assessment Method for the ICU (CAM-ICU) assessment	3 times per day, for a maximum of six (6) days	Research coordinator will perform and collect CAM-ICU assessment data on study subjects

Trial Locations

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; 🇺🇸 Saint 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