Development of Consciousness Measure and Monitor Device Based on Electroencephalography

Electroencephalography Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04952090
• Other study ID #: SNUEMS_HUMAN_EEG
• Status: Recruiting
• Start date: July 28, 2020
• Est. completion date: February 28, 2025

Study information

• Verified date: April 2023
• Source: Seoul National University Hospital
• Contact: Dong Hyun Choi
• Phone: +82-2-2072-4052
• Email: donghyun369[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: February 28, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Consciousness
• Electroencephalography

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	National Research Foundation of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).