Development of Consciousness Measure and Monitor Device Based on Electroencephalography

Seoul National University

Status: Enrolling

Conditions: Electroencephalography; Consciousness

Study type: Observational

Funder types: Other

Identifiers

NCT04952090

SNUEMS_HUMAN_EEG

Details and patient eligibility

About

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

Full description

Study objectives:

1. To develop a single-channel EEG database of emergency department (ED) patients with altered mental status.
2. To analyze single-channel EEG recordings and extract significant parameters.
3. 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.