Trial of Device for Seizure Detection Using SEDline During Therapeutic Hypothermia in Cardiac Arrest Victims
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Percentage of Seizure-positive and Seizure-negative That Were Correctly Classified by the SEDline in All Evaluated Cases
研究概览
简要总结
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.
详细描述
- Treatment of cardiac arrest victims Enrolled patients receive basic and advanced cardiac life support according to the 2010 American Heart Association (AHA) Guidelines for Cardiopulmonary Resuscitation (CPR) and Emergency Cardiovascular Care (ECC).
After acquiring sustained return of spontaneous circulation (ROSC), the patients are immediately admitted to the ICU and are provided postresuscitation care including mild therapeutic hypothermia for 24 hours post-ROSC.
During therapeutic hypothermia, their core temperatures are maintained from 32 to 34°C.
Then rewarming is conducted (< 0.25°C/hour) till core temperature 36.5°C. To avoid shivering, we use sedatives and neuromuscular blocking agents during the therapeutic hypothermia. 2. Conventional EEG Conventional EEG is conducted for 30 minutes at
- During therapeutic hypothermia and rewarming (within 72 hours after cardiac arrest) Then, the results are interpreted by a neurologist for the presence of seizure.
- SEDline SEDline is monitored during the simultaneous period with the conventional EEG. Data retrieved from the SEDline are blindly interpreted by 3 investigators to determine the presence of seizure activity.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Percentage of Seizure-positive and Seizure-negative That Were Correctly Classified by the SEDline in All Evaluated Cases
时间窗: Within 72 hours after cardiac arrest
Conventional EEG (gold standard for seizure detection) and SEDline monitoring will be conducted simultaneously for 30 minutes at During therapeutic hypothermia and rewarming (12 \~ 72 hours after cardiac arrest). Then, data retrieved from the conventional EEG and SEDline will be interpreted and analyzed for the presence of seizure.
次要结局
- Sensitivity of SEDline for Seizure Detection(Within 72 hours after cardiac arrest)
- Specificity(Within 72 hours after cardiac arrest)
- Negative Predictive Value(Within 72 hours after cardiac arrest)
- Positive Predictive Value(Within 72 hours after cardiac arrest)
- Area Under Receiver Operating Characteristics Curve (AUC) of SEDline for Seizure Detection(Within 72 hours after cardiac arrest)
研究者
Gil Joon Suh
Professor
Seoul National University Hospital