Rapid Bedside Evaluation of Seizures in the ICU by Listening to the Sound of Brainwaves: A Prospective Observational Clinical Trial of Ceribell’s Brain Stethoscope Function

Abstract

Background

Patients suffering from non-convulsive seizures experience delays in diagnosis and treatment due to limitations in acquiring and interpreting electroencephalography (EEG) data. The Ceribell EEG System offers rapid EEG acquisition and conversion of EEG signals to sound (sonification) using a proprietary algorithm. This study was designed to test the performance of this EEG system in an intensive care unit (ICU) setting and measure its impact on clinician treatment decision.

Methods

Encephalopathic ICU patients at Stanford University Hospital were enrolled if clinical suspicion for seizures warranted EEG monitoring. Treating physicians rated suspicion for seizure and decided if the patient needed antiepileptic drug (AED) treatment at the time of bedside evaluation. After listening to 30 s of EEG from each hemisphere in each patient, they reevaluated their suspicion for seizure and decision for additional treatment. The EEG waveforms recorded with Ceribell EEG were subsequently analyzed by three blinded epileptologists to assess the presence or absence of seizures within and outside the sonification window. Study outcomes were EEG set up time, ease of use of the device, change in clinician seizure suspicion, and change in decision to treat with AED before and after sonification.

Results

Thirty-five cases of EEG sonification were performed. Mean EEG setup time was 6 ± 3 min, and time to obtain sonified EEG was significantly faster than conventional EEG (p < 0.001). One patient had non-convulsive seizure during sonification and another had rhythmic activity that was followed by seizure shortly after sonification. Change in treatment decision after sonification occurred in approximately 40% of patients and resulted in a significant net reduction in unnecessary additional treatments (p = 0.01). Ceribell EEG System was consistently rated easy to use.

Conclusion

The Ceribell EEG System enabled rapid acquisition of EEG in patients at risk for non-convulsive seizures and aided clinicians in their evaluation of encephalopathic ICU patients. The ease of use and speed of EEG acquisition and interpretation by EEG-untrained individuals has the potential to improve emergent clinical decision making by quickly detecting non-convulsive seizures in the ICU.

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Funding

This study was supported by a fund from Ceribell, Inc. (Mountain View, CA, USA) to Stanford University.

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Affiliations

Authors

Contributions

All authors contributed substantially to the design and conduct of the study, data acquisition and/or analysis, and revision of the manuscript.

Corresponding author

Correspondence to Kyle Hobbs.

Ethics declarations

Conflict of interest

Josef Parvizi is co-founder of Ceribell. Goodman is on the Ceribell scientific advisory board. Both were involved in the design of the study, commenting on data analysis and interpretation, and revisions of later versions of the manuscript. Other authors have no financial relationship with Ceribell.

Ethical Approval

The trial was approved by our local Institutional Review Board, unique protocol number 38555.

Human and Animal Rights

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed Consent

Informed consent was obtained from all individual participants included in the study.

Electronic supplementary material

Below is the link to the electronic supplementary material.

Clip of visual handheld EEG and sonification of a patient in non-convulsive status epilepticus (NCSE) (MP4 25219 kb)

Video #1

Clip of visual handheld EEG and sonification of a patient in non-convulsive status epilepticus (NCSE) (MP4 25219 kb)

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Hobbs, K., Krishnamohan, P., Legault, C. et al. Rapid Bedside Evaluation of Seizures in the ICU by Listening to the Sound of Brainwaves: A Prospective Observational Clinical Trial of Ceribell’s Brain Stethoscope Function. Neurocrit Care 29, 302–312 (2018). https://doi.org/10.1007/s12028-018-0543-7

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Keywords

  • Electroencephalography
  • Sonification
  • Status epilepticus
  • Clinical trial