Frontal Amplitude-integrated Electroencephalogram in Early Prognostication After Cardiac Arrest

• Conditions: Heart Arrest
• Interventions: Device: Amplitude integrated electroencephalography

• Registration Number: NCT03154879
• Lead Sponsor: Seoul St. Mary's Hospital

Brief Summary

The investigators examine the prognostic value of continuous electroencephalography on frontal area of brain according to time by performing amplitude-integrated electroencephalography (aEEG) on cardiac arrest patients receiving therapeutic hypothermia.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-05
• Study First Submitted: 2017-05-07
• Study First Submitted QC: 2017-05-14
• Last Update Submitted: 2017-05-14
• Study First Posted: 2017-05-16
• Last Update Posted: 2017-05-16
• Study Start: 2017-06-01
• Primary Completion: 2020-05-31
• Study Completion: 2020-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• age: 19 years and older
• underwent TH

Exclusion Criteria

• Died within 72 h after cardiac arrest
• Spontaneous or traumatic brain injury
• Known history of neurological diseases (such as epilepsy)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Comatose cardiac arrest survivors	Amplitude integrated electroencephalography	-

Primary Outcome Measures

Name	Time	Method
Comparison of time to normal trace to good neurological outcome evaluated by cerebral performance category (CPC) score 1 to 2	at day 180	Time to normal trace is defined as time to regained normal trace on aEEG after return of spontaneous circulation.; The normal trace is defined as continuous cortical activity on the raw EEG scan; in addition, the upper margin of the aEEG scan, referred to as the aEEG maximum, was \>10 uV, and the lower margin of the aEEG scan, referred to as the aEEG minimum, was \>5 uV.

Secondary Outcome Measures

Name	Time	Method
Comparison of time to normal trace to poor neurological outcome evaluated by CPC score 3 to 5	at day 180	Time to normal trace is defined as time to regained normal trace on aEEG after return of spontaneous circulation.; The normal trace is defined as continuous cortical activity on the raw EEG scan; in addition, the upper margin of the aEEG scan, referred to as the aEEG maximum, was \>10 uV, and the lower margin of the aEEG scan, referred to as the aEEG minimum, was \>5 uV.
Comparison of unfavorable aEEG patterns to poor neurological outcome evaluated by CPC score 3 to 5	at day 180	Unfavorable aEEG patterns include flat trace (FT), burst-suppression (BS) and status epilepticus (SE).; FT is defined as isoelectric activity. BS is defined as the virtual absence of activity (\<2uV) between bursts of high voltage (\>25 uV).; SE was defined as repetitive epileptiform discharges with amplitudes \>50 uV and a median frequency 1 Hz for \>30 min.
Comparison of diffusion weighted image (DWI) to poor neurological outcome evaluated by CPC score 3 to 5	at day 180
Comparison of the levels of serum neuron specific enolase (NSE) to poor neurological outcome evaluated by CPC score 3 to 5	at day 180
Comparison of convulsive movement and electrical status epilepticus (SE) to poor neurological outcome evaluated by CPC score 3 to 5	at day 180

Trial Locations

Locations (4)

KEPCO Medical Center; 🇰🇷 Seoul, Korea, Republic of

Samsung Changwon Hospital; 🇰🇷 Changwon, Korea, Republic of

Chonnam National University; 🇰🇷 Gwangju, Korea, Republic of

Seoul St. Mary's hospital; 🇰🇷 Seoul, Korea, Republic of