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Status unknownNCT03545828MAEGICUpdated Sep 26, 2019

Multi-channel aEEG in Cardiac Arrest Patients With Targeted Temperature Management

An observational study in Heart Arrest and Targeted Temperature Management, sponsored by Sang Hoon Oh. Status unknown at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2019-09-26.

Sponsored by Sang Hoon Oh · Observational

The sponsor has not verified this record recently (last verified Sep 2019), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
78
Ages
19 Years and older
Sex
All
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Study summary

This study aims to examine the prognostic value of 18 channel amplitude-integrated EEG (aEEG) in comatose cardiac arrest patients The study design is a prospective observational study. Cardiac arrest patients undergoing targeted temperature management (TTM) will participate in the study. Relation of aEEG in each channel with the neurologic outcome at 6 month after return of spontaneous circulation (ROSC) will be evaluated.

Read the detailed description

Normal trace was 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 μ V, and the lower margin of the aEEG scan, referred to as the aEEG minimum, was >5 μ V. The Time from ROSC to normal trace (TTNT, hours) is predictor of neurological outcome in these patients. We will evaluate the prognostic values of TTNTs in all aEEG channels.

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Conditions studied

  • Heart Arrest
  • Targeted Temperature Management

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03

In context

Heart Arrest

966 studies on the registry are indexed under Heart Arrest; 227 are open to participants now.

This study's enrollment of 78 is below the median of 200 across 383 observational studies indexed under Heart Arrest.

Browse Heart Arrest studies →

Lead sponsor

This is the only study on the registry with Sang Hoon Oh as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

TTM treated cardiac arrest patients

Inclusion criteria

Comatose cardiac arrest TTM treatment Multi channel aEEG monitoring

Exclusion criteria

Exclusion Criteria:

Cerebral origin cardiac arrest Known epilepsy

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
78 participants (actual)
Target follow-up
6 Months
Patient registry
Yes

Groups and cohorts

  • Good neurological outcome

    CPC 1 and 2 at 6 month after ROSC

    Diagnostic Test: Multi-channel aEEG monitoring

  • Poor neurological outcome

    CPC 3 to 5 at 6 month after ROSC

    Diagnostic Test: Multi-channel aEEG monitoring

Interventions

  • Diagnostic testMulti-channel aEEG monitoring

    18 channel aEEG monitoring in comatose TTM-treated patients

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What researchers measure

Primary outcomes

  1. Time to normal trace in each aEEG channel

    Normal trace was 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 μ V, and the lower margin of the aEEG scan, referred to as the aEEG minimum, was \>5 μ V. The Time from ROSC to normal trace (TTNT, hours) is predictor of neurological outcome in these patients. We will evaluate the prognostic values of TTNTs in all aEEG channels.

    Time frame: at day 180

Secondary outcomes

  1. TTNT threshold for neurologic prognostication in each aEEG channel

    Using area under the curve (AUC) of each channel aEEG for neurological outcome, we will determine the best TTNT thresholds for good neurological outcome (CPC 1 to 2) in all aEEG channels.

    Time frame: at day 180

  2. Alpha delta ratio of each channel aEEG for good neurological outcome (CPC 1 to 2)

    The percentage powers in the alpha, theta and delta bands and the ratio of the powers in different frequency bands (i.e., alpha/delta) will be calculated. Finally we will evaluate the prognostic values of these ratios of the different bands.

    Time frame: at day 180

  3. Comparison of prognostic value between aEEG and various predictors

    We will compare the prognostic performances (i.e., sensitivity, specificity, AUC) for poor neurological outcome (CPC 3 to 5) between EEG and these predictors.

    Time frame: at day 180

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Study locations

1 site
  • Seoul St. Mary's hospital
    Seoul, 06591, Korea, Republic of
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03545828
Lead sponsor
Sang Hoon Oh
Responsible party
Sang Hoon Oh (Associate Professor, Seoul St. Mary's Hospital) — Sponsor-investigator
First posted
Jun 4, 2018
Start date
Jan 1, 2017
Primary completion
Jun 30, 2019
Completion
Dec 31, 2019 (estimated)
Last update
Sep 26, 2019

Study contacts

Sang Hoon Oh
study director · Seoul St. Mary's Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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