Clinical Data and Supporting Evidence: DECIDE Study

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 published in Critical Care Medicine.

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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 judgment alone is only slightly better than chance when making empiric decisions

Journal Reference

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

DECIDE Study Design

Prospective, multi-center study conducted at 5 top-tier facilities who had 24/7 EEG access

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 patients


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

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 and 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.

Physician Characteristics

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

Vespa, P.M., et al. (2020) Crit Care Med. 48(9):1249-1257