Seizure Detection Using SEDline During Therapeutic Hypothermia in Cardiac Arrest Victims

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2013 by Seoul National University Hospital
Sponsor:
Collaborators:
Masimo Corporation
Humed Co., Ltd
Information provided by (Responsible Party):
Gil Joon Suh, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01946802
First received: September 11, 2013
Last updated: September 16, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Cardiac Arrest
Device: Frontal 4 channel EEG

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Trial of Device for Seizure Detection Using SEDline During Therapeutic Hypothermia in Cardiac Arrest Victims

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Accuracy of SEDline for seizure detection [ Time Frame: Within 6 months after complete data collection (March, 2015) ] [ Designated as safety issue: No ]
    Conventional EEG (gold standard for seizure detection) and SEDline monitoring will be conducted simultaneously for 30 minutes at 1) During therapeutic hypothermia (within 24 hours after cardiac arrest) and 2) After the completion of rewarming (48 ~ 72 hours after cardiac arrest). Then, data retrieved from the conventional EEG and SEDline will be interpreted and analyzed for the presence of seizure.


Secondary Outcome Measures:
  • Sensitivity of SEDline for seizure detection [ Time Frame: Within 6 months after complete data collection (March, 2015) ] [ Designated as safety issue: No ]
    Conventional EEG (gold standard for seizure detection) and SEDline monitoring will be conducted simultaneously for 30 minutes at 1) During therapeutic hypothermia (within 24 hours after cardiac arrest) and 2) After the completion of rewarming (48 ~ 72 hours after cardiac arrest). Then, data retrieved from the conventional EEG and SEDline will be interpreted and analyzed for the presence of seizure.

  • Specificity [ Time Frame: Within 6 months after complete data collection (March, 2015) ] [ Designated as safety issue: No ]
    Same as above description

  • Positive predictive value [ Time Frame: Within 6 months after complete data collection (March, 2015) ] [ Designated as safety issue: No ]
    Same as above description

  • Negative predictive value [ Time Frame: Within 6 months after complete data collection (March, 2015) ] [ Designated as safety issue: No ]
    Same as above description

  • Area under receiver operating characteristics curve (AUC) of SEDline for seizure detection [ Time Frame: Within 6 months after complete data collection (March, 2015) ] [ Designated as safety issue: No ]
    Same as above description


Estimated Enrollment: 44
Study Start Date: October 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Frontal 4 channel EEG
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.
Device: Frontal 4 channel EEG
Simultaneous conventional EEG and SEDline monitoring for 30 minutes during and after therapeutic hypothermia
Other Name: SEDline, Masimo corporation

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 (within 24 hours after cardiac arrest)
    2. After the completion of rewarming (48 ~ 72 hours after cardiac arrest) Then, the results are interpreted by a neuro-intensivist 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01946802

Contacts
Contact: Yoon Sun Jung, MD 82-2-2072-0326 loctos00@hanmail.net

Locations
Korea, Republic of
Department of Emergency Medicine, Seoul National University Hospital Not yet recruiting
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Gil Joon Suh
Masimo Corporation
Humed Co., Ltd
Investigators
Study Director: Gil Joon Suh, Prof Seoul National University Hospital
  More Information

Publications:
Responsible Party: Gil Joon Suh, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01946802     History of Changes
Other Study ID Numbers: H-1303-013-470
Study First Received: September 11, 2013
Last Updated: September 16, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
Heart arrest
Cardiopulmonary resuscitation
Hypothermia induced
Seizures
Electroencephalography

Additional relevant MeSH terms:
Heart Arrest
Hypothermia
Seizures
Heart Diseases
Cardiovascular Diseases
Body Temperature Changes
Signs and Symptoms
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations

ClinicalTrials.gov processed this record on July 23, 2014