Ceribell Monitoring for Delirium

(DOM Trial)

MH
AC
Overseen ByAlexandra C. Fietsam, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Ceribell Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Are You a Good Fit for This Trial?

Inclusion Criteria

I am in the ICU after heart or chest surgery with sepsis, shock, or breathing support.
I am 18 years old or older.
I am expected to stay in the ICU for at least 24 hours.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Prospective Ceribell Delirium Monitoring

ICU patients undergo up to 12 hours of continuous EEG recording with the Ceribell Delirium Monitor for up to 7 days. Delirium Trend Reports are presented during morning rounds.

7 days

Retrospective Control

Data on delirium management and patient clinical outcomes are collected from chart review for patients in the retrospective control arm.

7 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Ceribell Delirium Monitoring System

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Prospective Ceribell Delirium MonitoringExperimental Treatment1 Intervention
Group II: Retrospective ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ceribell Inc.

Lead Sponsor

Trials
2
Recruited
360+