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

Neurological Prognostication Using Multi-channel Amplitude-integrated Electroencephalographic Monitoring in Cardiac Arrest Patients With Targeted Temperature Management

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03545828
Acronym
MAEGIC
Enrollment
78
Registered
2018-06-04
Start date
2017-01-01
Completion date
2019-12-31
Last updated
2019-09-26

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

Conditions

Heart Arrest, Targeted Temperature Management

Brief 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.

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.

Interventions

DIAGNOSTIC_TESTMulti-channel aEEG monitoring

18 channel aEEG monitoring in comatose TTM-treated patients

Sponsors

Sang Hoon Oh
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

Comatose cardiac arrest TTM treatment Multi channel aEEG monitoring

Exclusion criteria

Cerebral origin cardiac arrest Known epilepsy

Design outcomes

Primary

MeasureTime frameDescription
Time to normal trace in each aEEG channelat day 180Normal 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.

Secondary

MeasureTime frameDescription
TTNT threshold for neurologic prognostication in each aEEG channelat day 180Using 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.
Alpha delta ratio of each channel aEEG for good neurological outcome (CPC 1 to 2)at day 180The 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.
Comparison of prognostic value between aEEG and various predictorsat day 180We will compare the prognostic performances (i.e., sensitivity, specificity, AUC) for poor neurological outcome (CPC 3 to 5) between EEG and these predictors.

Countries

South Korea

Outcome results

None listed

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