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

Heart Arrest Clinical Trial

— MAEGIC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03545828
• Other study ID #: MAEGIC-01
• Status: Active, not recruiting
• Start date: January 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: September 2019
• Source: Seoul St. Mary's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 78
• Est. completion date: December 31, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

Comatose cardiac arrest TTM treatment Multi channel aEEG monitoring

Exclusion Criteria:

Cerebral origin cardiac arrest Known epilepsy

Related Conditions & MeSH terms

• Heart Arrest
• Targeted Temperature Management

Intervention

Diagnostic Test:
• Multi-channel aEEG monitoring
18 channel aEEG monitoring in comatose TTM-treated patients

Locations

Country	Name	City	State
Korea, Republic of	Seoul St. Mary's hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Sang Hoon Oh

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	at day 180
Secondary	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.	at day 180
Secondary	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.	at day 180
Secondary	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.	at day 180