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Frontal Amplitude-integrated Electroencephalogram in Early Prognostication After Cardiac Arrest

Prospective Multi-center Study to Verify Neurological Prognostic Value of Amplitude-integrated Electroencephalogram in Cardiac Arrest Patients Treated With Therapeutic Hypothermia

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03154879
Acronym
FRONTEER
Enrollment
500
Registered
2017-05-16
Start date
2017-06-01
Completion date
2020-05-31
Last updated
2017-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Arrest

Keywords

Heart arrest, Hypothermia, EEG, Prognosis

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.

Interventions

DEVICEAmplitude integrated electroencephalography

Frontal Amplitude-integrated Electroencephalogram in Early Prognostication After Cardiac Arrest

Sponsors

Seoul St. Mary's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Comparison of time to normal trace to good neurological outcome evaluated by cerebral performance category (CPC) score 1 to 2at day 180Time 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

MeasureTime frameDescription
Comparison of convulsive movement and electrical status epilepticus (SE) to poor neurological outcome evaluated by CPC score 3 to 5at day 180
Comparison of time to normal trace to poor neurological outcome evaluated by CPC score 3 to 5at day 180Time 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 5at day 180Unfavorable 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 5at day 180
Comparison of the levels of serum neuron specific enolase (NSE) to poor neurological outcome evaluated by CPC score 3 to 5at day 180

Countries

South Korea

Contacts

Primary ContactSang Hoon Oh, MD
ohmytweety@catholic.ac.kr82-2-2258-1987

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026