N/A
N=44
Seizure Detection Using SEDline During Therapeutic Hypothermia in Cardiac Arrest Victims
Cardiac Arrest
Bottom Line
View on ClinicalTrials.gov: NCT01946802 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcome: Primary: Percentage of Seizure-positive and Seizure-negative That Were Correctly Classified by the SEDline in All Evaluated Cases — 100 percentage of seizures
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Frontal 4 channel EEG (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Gil Joon Suh
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Seizure-positive and Seizure-negative That Were Correctly Classified by the SEDline in All Evaluated Cases |
100 | — |
| SECONDARY Sensitivity of SEDline for Seizure Detection |
100 | — |
| SECONDARY Specificity |
100 | — |
| SECONDARY Positive Predictive Value |
100 | — |
| SECONDARY Negative Predictive Value |
100 | — |
| SECONDARY Area Under Receiver Operating Characteristics Curve (AUC) of SEDline for Seizure Detection |
1.00 | — |
Summary
Current guidelines recommend the use of sedatives and neuromuscular blocking agents to avoid shivering during therapeutic hypothermia in cardiac arrest victims. Therefore, it is difficult to detect seizure and the frequent or continuous EEG monitoring is recommended. However, it is difficult to follow this recommendation in most clinical situations due to the lack of specialized devices and persons. The purpose of this study is whether SEDline (frontal 4-channel EEG device) has a diagnostic value to detect seizure during therapeutic hypothermia in cardiac arrest victims.
Eligibility Criteria
Inclusion Criteria
- Consecutive comatose patients admitted to the emergency ICU for postresuscitation care following successful cardiopulmonary resuscitation after nontraumatic out-of-hospital and in-hospital cardiac arrest.
- Cardiac arrest is defined as cessation of cardiac mechanical activity, confirmed by the absence of a detectable pulse, unresponsiveness, and apnea.
Exclusion Criteria
- Age < 18 years old
- Contraindication to therapeutic hypothermia: active life-threatening bleeding, septic shock, or refractory fatal arrhythmia..
- Intracranial pathology including hemorrhage or tumor
- Visible generalized seizure before the study enrollment
- Advanced directives to withdraw life-sustaining treatment
- No informed consent
Data sourced from ClinicalTrials.gov (NCT01946802). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.