Development of Consciousness Measure and Monitor Device B... | NCT04952090

Studies
Development of Consciousness Measure and Monitor Device Based on Electroencephalography

NCT04952090

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Apr 20, 2023Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Electroencephalography
Consciousness

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 28, 2020Actual

Primary Completion Date

Feb 28, 2025Estimated

Completion Date

Feb 28, 2025Estimated

First Submitted Date

Jun 20, 2021

First Submission Date that Met QC Criteria

Jun 27, 2021

First Posted Date

Jul 7, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2023

Last Update Posted Date

Apr 20, 2023Actual

Name	Class
National Research Foundation of Korea	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Study objectives:

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Outcomes Module

Primary Outcomes

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 Outcomes

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).

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dong Hyun Choi	Contact	+82-2-2072-4052		donghyun369@snu.ac.kr

Overall Officials

Name	Affiliation	Role
Ki Hong Kim	Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital	Recruiting	Seoul			South Korea