200 Participants Needed

Ceribell EEG for Delirium

Recruiting at 7 trial locations
KS
JD
MH
Overseen ByMichelle Hofmann, MSN
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 trial aims to collect data to develop new software for identifying and measuring delirium, a condition causing confusion and disorientation. The Ceribell EEG, a device that reads brain activity, will monitor patients for different types of delirium in the ICU. Ideal candidates for this study are ICU patients who can communicate in the language used for the delirium assessment. The researchers hope this study will create better tools for detecting and understanding delirium in the future. As an unphased trial, it offers participants the chance to contribute to innovative research that could significantly advance delirium detection and care.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Ceribell EEG is safe for monitoring delirium?

Research has shown that the Ceribell EEG system, which monitors brain activity, is generally safe for patients. Some studies found that the main side effect is minor skin irritation at the electrode sites, but this is usually not serious.

However, incorrect readings can occur if a qualified person does not review the EEG data. Results could be misunderstood without expert evaluation.

Overall, the Ceribell EEG is well-tolerated and has been used safely in many hospitals. No reports of major problems have been directly linked to its use.12345

Why are researchers excited about this trial?

Researchers are excited about the Ceribell EEG because it offers a novel approach to diagnosing and managing delirium. Unlike traditional methods that rely on clinical observation and cognitive tests, Ceribell EEG uses a rapid, portable electroencephalogram (EEG) device to detect brain activity changes in real-time. This quick and efficient method can potentially identify delirium earlier, allowing for faster intervention and management. Additionally, its portability makes it suitable for various clinical settings, providing a significant advantage over stationary EEG machines. This innovation could transform how delirium is identified and treated, leading to better patient outcomes.

What evidence suggests that Ceribell EEG is effective for monitoring delirium?

Research has shown that the Ceribell EEG effectively identifies seizures quickly, especially in critical care settings. Studies indicate it reduces the time needed to diagnose conditions like status epilepticus, a severe, ongoing seizure, compared to standard methods. This faster diagnosis can lead to better patient outcomes and shorter hospital stays. The tool is already recognized for improving seizure management in very sick patients. While this study focuses on delirium, the success of Ceribell EEG in similar situations offers hope for its potential to help assess delirium as well.678910

Who Is on the Research Team?

JM

Jose Maldonado, MD

Principal Investigator

Stanford University

TG

Timothy Girard, MD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

Inclusion Criteria

Inclusion Criteria: All must be present
Admitted to the Intensive Care Unit (ICU)
Subject must be fluent in the language in which the delirium assessment is performed

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Data Collection

EEG and clinical data are collected to monitor subjects for delirium subtypes

6 days
3 visits per day (in-person)

Follow-up

Participants are monitored for safety and effectiveness after data collection

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Ceribell EEG

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ceribell Inc.

Lead Sponsor

Trials
2
Recruited
360+

Citations

Clinical Studies

The Ceribell Point-of-Care EEG system has a wealth of clinical evidence demonstrating its benefits. Explore the clinical studies and supporting evidence.

Ceribell EEG shortens seizure diagnosis and workforce time ...

The 8‐channel Ceribell EEG shortened the time to diagnosis of SE and non‐SE conditions compared with standard 18‐channel electroencephalography. It also reduced ...

Impact Survey

Over 7500 acute care providers reported how point-of-care EEG is improving seizure management of critically ill patients. Read more here.

Ceribell Point-of-Care EEG Platform Outperforms ...

Early use of Ceribell's POC-EEG system significantly improves detection of nonconvulsive seizures, reduces ICU length of stay, and enhances patient outcomes.

The Efficacy of CERIBELL in Acute Neurological ...

Conclusions: The Ceribell EEG is an effective tool in the emergency room for diagnosing status epilepticus in 9% of cases. Of the remaining ...

Ceribell | Indications, Safety & Warnings

Potential Adverse Events · Minor skin irritation at electrode sites · Risk of misinterpretation if EEG data is not reviewed by qualified personnel · False ...

EEG Recorder Operator Manual

All of the EEG data used for Ceribell's seizure detection val- idation was retrospectively obtained from pre-existing EEG databases. The EEG trained ...

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ceribell.com

ceribell.com/

Ceribell | Home

Triage and continuously monitor hospital patients at risk for seizures in minutes with Ceribell's point-of-care EEG solution. Learn more.

March 21, 2023 Ceribell, Inc. Raymond Woo, PhD Chief ...

The Ceribell Instant EEG ... data were provided to demonstrate safety and efficacy in support of substantial equivalence determination:.

Point-of-Care EEG

Ceribell Indications, Safety & Warnings ... Real-time streaming of EEG data to a cloud-based portal enables physicians to review EEG data from anywhere.

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