Development of Consciousness Measure and Monitor Device Based on Electroencephalography

Study Overview
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Brief Summary
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This study aims to develop a consciousness measuring and monitoring device using a single-channel electroencephalogram (EEG).

Detailed Description
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Study objectives: To develop a single-channel EEG database of emergency department (ED) patients with altered mental status. To analyze single-channel EEG recordings and extract significant parameters. To develop a consciousness prediction model using single-channel EEG. Study design: observational multicenter study in 6 tertiary hospital EDs in Korea (Seoul National University Hospital, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Kyungpook National University Hospital, Chungbuk National University Hospital, Chonnam National University Hospital, Korea University Ansan Hospital). The investigators will obtain single-channel EEG data of ED patients with altered consciousness and develop a prospective database of the data. With the constructed database, a consciousness prediction model using single-channel EEG will be developed. The prediction performance of the developed model using area under receiver operating characteristic curve (AUC) will be evaluated.

Official Title
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Development of Consciousness Measure and Monitor Device Based on Quantitative Electroencephalography Analysis In Emergency Patient

Conditions
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Electroencephalography, Consciousness

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult ED patients with a decreased level of consciousness (verbal, pain, or unresponsive using the AVPU scale, and a GCS-E score of less than 4) who have stayed at the ED for less than 12 hours at the time of enrollment. Exclusion Criteria: Patients with the difficulty of applying EEG due to head trauma or skull deformities. Patients for whom standard treatment may be significantly delayed by applying the EEG device. Patients with a guardian who do not agree to enroll in this study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consciousness level using the Glasgow Coma Scale (GCS) scale. | The GCS score ranges from 15 to 3 points, with a higher score indicating an alert consciousness and a lower score indicating decreased consciousness. A binary outcome of GCS<=8 and GCS>8 will be used in this study. | At the time of study completion (May 31, 2023, anticipated). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consciousness level using the AVPU (Alert; Verbal; Pain; Unresponsive) scale. | A multi-class outcome (A: alert, V: verbal, P: pain, U: unresponsive) will be used in this study. | At the time of study completion (May 31, 2023, anticipated). |