Clinical trial NCT04952090: Development of Consciousness Measure and Monitor Device Based on Electroencephalography
Official title: Development of Consciousness Measure and Monitor Device Based on Quantitative Electroencephalography Analysis In Emergency Patient
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Electroencephalography
Consciousness
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: National Research Foundation of Korea
First posted: 2021-07-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Consciousness level using the Glasgow Coma Scale (GCS) scale.
timeFrame: At the time of study completion (May 31, 2023, anticipated).
Secondary outcomes:
measure: Consciousness level using the AVPU (Alert; Verbal; Pain; Unresponsive) scale.
timeFrame: At the time of study completion (May 31, 2023, anticipated).
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Ki Hong Kim
role: PRINCIPAL_INVESTIGATOR
References: