Development of Consciousness Measure and Monitor Device Based on Electroencephalography

Recruiting

• Conditions: Consciousness; Electroencephalography

• Registration Number: NCT04952090
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2020-07-28
• Study First Submitted: 2021-06-20
• Study First Submitted QC: 2021-06-27
• Study First Posted: 2021-07-07
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-19
• Last Update Posted: 2023-04-20
• Primary Completion: 2025-02-28
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Consciousness level using the Glasgow Coma Scale (GCS) scale.	At the time of study completion (May 31, 2023, anticipated).	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of