Clinical trial NCT01946802: Seizure Detection Using SEDline During Therapeutic Hypothermia in Cardiac Arrest Victims
Official title: Trial of Device for Seizure Detection Using SEDline During Therapeutic Hypothermia in Cardiac Arrest Victims
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrest
Keywords: Heart arrest
Cardiopulmonary resuscitation
Hypothermia induced
Seizures
Electroencephalography
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Masimo Corporation
name: Humed Co., Ltd
First posted: 2013-09-20
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Comatose cardiac arrest survivors admitted to a 12-bed emergency intensive care unit of Seoul National University Hospital, Seoul, Republic of Korea.

Brief 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.

Detailed description: 1. 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

   1) During therapeutic hypothermia and rewarming (within 72 hours after cardiac arrest) Then, the results are interpreted by a neurologist for the presence of seizure.
3. 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.

   The presence of seizure activity in SEDline is determined by the definition
   1. Electrographic seizure: rhythmic discharge or spike and wave pattern with definite evolution in frequency, location, or morphology lasting several seconds.
   2. Spike: Transient, clearly distinguishable from background activity, with pointed peak at conventional paper speeds and a duration of 20 to less than 70 ms
4. Anti-epileptic drug The use of anti-epileptic drugs is guided by the results of conventional EEG or the presence of clinically seizure-like movement
5. Gold standard The presence of Seizure identified in conventional EEG.
6. Primary outcome The diagnostic performance of SEDline to detect seizure will be tested: Sensitivity, specificity, positive predictive value, negative predictive value, accuracy, and area under receiver operating characteristics curve (AUC).

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

Primary outcomes:
measure: Percentage of Seizure-positive and Seizure-negative That Were Correctly Classified by the SEDline in All Evaluated Cases
timeFrame: Within 72 hours after cardiac arrest
Secondary outcomes:
measure: Sensitivity of SEDline for Seizure Detection
timeFrame: Within 72 hours after cardiac arrest
measure: Specificity
timeFrame: Within 72 hours after cardiac arrest
measure: Positive Predictive Value
timeFrame: Within 72 hours after cardiac arrest
measure: Negative Predictive Value
timeFrame: Within 72 hours after cardiac arrest
measure: Area Under Receiver Operating Characteristics Curve (AUC) of SEDline for Seizure Detection
timeFrame: Within 72 hours after cardiac arrest
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Emergency Medicine, Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Gil Joon Suh, Prof
role: STUDY_DIRECTOR
References:
citation: HOCKADAY JM, POTTS F, EPSTEIN E, BONAZZI A, SCHWAB RS. ELECTROENCEPHALOGRAPHIC CHANGES IN ACUTE CEREBRAL ANOXIA FROM CARDIAC OR RESPIRATORY ARREST. Electroencephalogr Clin Neurophysiol. 1965 May;18:575-86. doi: 10.1016/0013-4694(65)90075-1. No abstract available.
citation: Rossetti AO, Urbano LA, Delodder F, Kaplan PW, Oddo M. Prognostic value of continuous EEG monitoring during therapeutic hypothermia after cardiac arrest. Crit Care. 2010;14(5):R173. doi: 10.1186/cc9276. Epub 2010 Sep 29.
citation: Crepeau AZ, Rabinstein AA, Fugate JE, Mandrekar J, Wijdicks EF, White RD, Britton JW. Continuous EEG in therapeutic hypothermia after cardiac arrest: prognostic and clinical value. Neurology. 2013 Jan 22;80(4):339-44. doi: 10.1212/WNL.0b013e31827f089d. Epub 2013 Jan 2.