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

• Conditions: Heart Arrest; Targeted Temperature Management
• Interventions: Diagnostic Test: Multi-channel aEEG monitoring

• Registration Number: NCT03545828
• Lead Sponsor: Sang Hoon Oh

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.

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2018-04-22
• Study First Submitted QC: 2018-05-22
• Study First Posted: 2018-06-04
• Primary Completion: 2019-06-30
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-24
• Last Update Posted: 2019-09-26
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

Comatose cardiac arrest TTM treatment Multi channel aEEG monitoring

Exclusion Criteria

Cerebral origin cardiac arrest Known epilepsy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Poor neurological outcome	Multi-channel aEEG monitoring	CPC 3 to 5 at 6 month after ROSC
Good neurological outcome	Multi-channel aEEG monitoring	CPC 1 and 2 at 6 month after ROSC

Primary Outcome Measures

Name	Time	Method
Time to normal trace in each aEEG channel	at day 180	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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