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

Abstract

Objectives: To measure the diagnostic accuracy, timeliness, and ease of use of Ceribell rapid response electroencephalography. We assessed physicians' diagnostic assessments and treatment plans before and after rapid response electroencephalography assessment. Primary outcomes were changes in physicians' diagnostic and therapeutic decision making and their confidence in these decisions based on the use of the rapid response electroencephalography system. Secondary outcomes were time to electroencephalography, setup time, ease of use, and quality of electroencephalography data.

Design: Prospective multicenter nonrandomized observational study.

Setting: ICUs in five academic hospitals in the United States.

Subjects: Patients with encephalopathy suspected of having nonconvulsive seizures and physicians evaluating these patients.

Interventions: Physician bedside assessment of sonified electroencephalography (30 s from each hemisphere) and visual electroencephalography (60 s) using rapid response electroencephalography.

Measurements and main results: Physicians (29 fellows or residents, eight attending neurologists) evaluated 181 ICU patients; complete clinical and electroencephalography data were available in 164 patients (average 58.6 ± 18.7 yr old, 45% females). Relying on rapid response electroencephalography information at the bedside improved the sensitivity (95% CI) of physicians' seizure diagnosis from 77.8% (40.0%, 97.2%) to 100% (66.4%, 100%) and the specificity (95% CI) of their diagnosis from 63.9% (55.8%, 71.4%) to 89% (83.0%, 93.5%). Physicians' confidence in their own diagnosis and treatment plan were also improved. Time to electroencephalography (median [interquartile range]) was 5 minutes (4-10 min) with rapid response electroencephalography while the conventional electroencephalography was delayed by several hours (median [interquartile range] delay = 239 minutes [134-471 min] [p < 0.0001 using Wilcoxon signed rank test]). The device was rated as easy to use (mean ± SD: 4.7 ± 0.6 [1 = difficult, 5 = easy]) and was without serious adverse effects.

Conclusions: Rapid response electroencephalography enabled timely and more accurate assessment of patients in the critical care setting. The use of rapid response electroencephalography may be clinically beneficial in the assessment of patients with high suspicion for nonconvulsive seizures and status epilepticus.

Trial registration: ClinicalTrials.gov NCT03534258.

Figures

Figure 1.

Rapid Response Electroencephalogram (Rapid-EEG) System. Rapid-EEG developed by Ceribell enables electroencephalogram (EEG) acquisition without trained EEG technologists and provides EEG diagnostic information in real time by three means: 1) the visual display on the device screen, 2) the “Brain Stethoscope” (38) function activated by a button press on the device that enables the user to “listen” to the sound of the brain (for samples, see “Brain Stethoscope Training” at https://ceribell.com/training.html), and 3) real-time wireless transmission of the EEG data to a cloud server for remote evaluation (either in real time or retrospectively) by neurologists using a web browser interface. The electrodes are configured in a bipolar montage with five electrodes (four electrode pairs) on each hemisphere. The EEG channels correspond approximately to the Fp1–F7, F7–T3, T3–T5, and T5–O1 sites on the left and the Fp2–F8, F8–T4, T4–T6, and T6–O2 sites on the right according to the International 10–20 System. Data are acquired as digital samples at a rate of 250 Hz with a frequency response of 0.5–100 Hz.

Figure 2.

Flow diagram and study protocol. The results of the study are based on 181 patient encounters with questionnaire data completed by 37 physicians and 164 patients with Rapid Response Electroencephalogram (Rapid-EEG) data (left). The study protocol (right) demonstrates the timing of physician questionnaires before and after Rapid-EEG assessment and the electroencephalogram (EEG) review process. Physicians were instructed not to delay the conventional EEG system in the process of acquiring Rapid-EEG data. Clinical Report Forms (CRF) were used.

Figure 3.

Primary and secondary study outcomes. A, Clinical impact: Bar graphs comparing physicians’ diagnostic and treatment decisions and confidence level for all 181 cases (two values missing). High confidence combined “high” and “very high” categories (ratings of 4 and 5). B, Time to EEG: Delays in obtaining Rapid-EEG (blue) compared with conventional EEG (orange) during business hours (lighter shade) and after-hours (darker shade). Note the high variance in hours to conventional EEG across sites compared with minutes to obtain Rapid-EEG. C, Ease of use: Perceived ease of use of the headband sensors (light blue) and recording device (dark blue) was high.