Ceribell Delirium Data Collection Study

Ceribell

Status: Enrolling

Conditions: Delirium

Treatments: Device: Electroencephalogram (EEG) Test

Study type: Observational

Funder types: Industry

Identifiers

NCT04962815

2021-01

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.