Development of Consciousness Measure and Monitor Device Based on Electroencephalography

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

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

Study Overview

• Status: Recruiting
• Conditions: Electroencephalography; Consciousness

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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Dong Hyun Choi; Phone Number: +82-2-2072-4052; Email: donghyun369@snu.ac.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul National University Hospital
    • Contact: Ki Hong Kim; Phone Number: +82-2-2072-4052; Email: emphysiciankkh@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with a decreased level of consciousness who have visited the study hospital EDs and have stayed at the ED for less than 12 hours at the time of enrollment will be included.

Description

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 Plan

How is the study designed?

What is the study measuring?

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).

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: National Research Foundation of Korea
• Investigators: Principal Investigator: Ki Hong Kim, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2020
• Primary Completion (Anticipated): February 28, 2025
• Study Completion (Anticipated): February 28, 2025

Study Registration Dates

• First Submitted: June 20, 2021
• First Submitted That Met QC Criteria: June 27, 2021
• First Posted (Actual): July 7, 2021

Study Record Updates

• Last Update Posted (Actual): April 20, 2023
• Last Update Submitted That Met QC Criteria: April 19, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: SNUEMS_HUMAN_EEG

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No