Multi-channel aEEG in Cardiac Arrest Patients With Targeted Temperature Management
MAEGIC
Neurological Prognostication Using Multi-channel Amplitude-integrated Electroencephalographic Monitoring in Cardiac Arrest Patients With Targeted Temperature Management
1 other identifier
observational
78
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
April 22, 2018
CompletedFirst Posted
Study publicly available on registry
June 4, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedSeptember 26, 2019
September 1, 2019
2.5 years
April 22, 2018
September 24, 2019
Conditions
Outcome Measures
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.
at day 180
Secondary Outcomes (3)
TTNT threshold for neurologic prognostication in each aEEG channel
at day 180
Alpha delta ratio of each channel aEEG for good neurological outcome (CPC 1 to 2)
at day 180
Comparison of prognostic value between aEEG and various predictors
at day 180
Study Arms (2)
Good neurological outcome
CPC 1 and 2 at 6 month after ROSC
Poor neurological outcome
CPC 3 to 5 at 6 month after ROSC
Interventions
18 channel aEEG monitoring in comatose TTM-treated patients
Eligibility Criteria
TTM treated cardiac arrest patients
You may qualify if:
- Comatose cardiac arrest TTM treatment Multi channel aEEG monitoring
You may not qualify if:
- Cerebral origin cardiac arrest Known epilepsy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sang Hoon Ohlead
Study Sites (1)
Seoul St. Mary's hospital
Seoul, 06591, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sang Hoon Oh
Seoul St. Mary's Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
April 22, 2018
First Posted
June 4, 2018
Study Start
January 1, 2017
Primary Completion
June 30, 2019
Study Completion
December 31, 2019
Last Updated
September 26, 2019
Record last verified: 2019-09