Clinical Data and Supporting Evidence: DECIDE Study

Fast. Accurate. Informed. Decisive.

Ceribell™ Rapid Response EEG was demonstrated to significantly improve clinical accuracy

Results from the DECIDE study (a prospective, multi-center clinical trial to assess Ceribell™ Rapid Response EEG impact on clinical decision-making) were recently published in Critical Care Medicine.

WITHOUT CERIBELL RAPID RESPONSE EEG

  • Even top academic centers with 24/7 EEG capability have a 4-hour wait-time for conventional EEG.
  • Diagnostic accuracy of physicians relying on clinical judgement alone is only slightly better than chance when making empiric decisions

Access to Ceribell Rapid Response EEG Changes Everything

Evaluating the Clinical Impact of Rapid Response
Electroencephalography: The DECIDE Multicenter
Prospective Observational Clinical Study

Critical Care Medicine. 48(9):1249-1257, September 2020.

Published by:
Vespa, Paul M.; Olson, DaiWai M.; John, Sayona; Hobbs, Kyle S.; Gururangan, Kapil; Nie, Kun; Desai, Masoom J.; Markert, Matthew; Parvizi, Josef; Bleck, Thomas P.; Hirsch, Lawrence J.; Westover, M. Brandon Less

Investigators

Kyle Hobbs, MD
Wake Forest Baptist Health

Sayona John, MD
Rush University Medical Center

DaiWai Olson, RN, PhD
The University of Texas Southwestern Medical Center

Paul M. Vespa, MD
David Geffen School of Medicine at UCLA

Michael Brandon Westover, MD, PhD
Massachusetts General Hospital

Advisors

Thomas P. Bleck, MD
Rush University Medical Center

Lawrence Hirsch, MD
Yale School of Medicine

The study evaluated 181 patients to assess the performance of the Ceribell Rapid Response EEG system in critical care situations versus that of conventional EEG

37

bedside ICU physicians

181

patients

1) Pre-rapid EEG

  • Conventional EEG is ordered (time is documented)
  • Pre-rapid EEG case form is completed 

2) Rapid EEG

  • Rapid EEG conducted (time is documented)
  • Post-rapid EEG case form is completed
  • Rapid EEG is reviewed by 3 epileptologists and classified by majority consensus

3) Conventional EEG

  • Conventional EEG arrives (time is collected)
  • Conventional EEG recording starts (time is collected)
  • Conventional EEG recording is collected

Physician Case Form

Key Results

4 HRS

Wait-time to Conventional EEG Versus 5 Minutes with Ceribell EEG

  • Even in top academic centers with 24/7 on-site EEG technologists
90 %

Diagnostic accuracy with the Ceribell Versus 65% Using Clinical Judgement Alone

  • With Ceribell EEG, sensitivity for detection of seizures was 100% and specificity improved by 25 percentage points..
86 %

Diagnostic Confidence With Ceribell Versus 40% Using Clinical Judgement Alone

  • With Ceribell EEG, bedside clinicians rated their confidence high or very high 86% of the time.

Physician Characteristics

Physician Characteristics

  • 37 physicians participated
  • All physicians were neurology-trained with varying years of ICU experience and minimal EEG experience

Patient Characteristics

Patient Characteristics

  • 181 patients suspected to have non-convulsive seizures for which conventional EEG was ordered were enrolled
  • Most patients were already on anti-seizure medications (69%)
  • 57% of patients were already intubated
  • The majority of patients had some degree of encephalopathy either with or without witnessed seizure or seizure-like activity.

Additional Resources

Title: SCCM Journal Club: Dr. Paul Vespa discusses the DECIDE Study

to receive registration
information

Dr. Paul Vespa of UCLA was an integral part of the DECIDE prospective study and was invited to present this important original research at an SCCM journal club.

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Caution: Federal (US) law restricts this device to sale by or on the order of a physician. The Ceribell EEG Headband and the Ceribell EEG Recorder are intended to be used by trained healthcare providers in a professional healthcare facility environment. The Ceribell EEG Recorder does not provide any diagnostic conclusion about the subject’s condition and does not provide any automated alerts of an adverse clinical event. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.

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