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Completed

NCT Number: NCT01946802

Seizure Detection Using SEDline During Therapeutic Hypothermia in Cardiac Arrest Victims

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Emergency Medicine, Seoul National University Hospital

Seoul, 110-744, South Korea

About this study

  • 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.

  • 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.

The presence of seizure activity in SEDline is determined by the definition

  • Electrographic seizure: rhythmic discharge or spike and wave pattern with definite evolution in frequency, location, or morphology lasting several seconds.
  • Spike: Transient, clearly distinguishable from background activity, with pointed peak at conventional paper speeds and a duration of 20 to less than 70 ms
  • 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
  • Gold standard The presence of Seizure identified in conventional EEG.
  • 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Frontal 4 channel EEG

Device

Simultaneous conventional EEG and SEDline monitoring for 30 minutes during and after therapeutic hypothermia

Other names: SEDline, Masimo corporation

Primary outcomes

  1. Percentage of Seizure-positive and Seizure-negative That Were Correctly Classified by the SEDline in All Evaluated Cases

    Time frame: 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.

Secondary outcomes

  1. Sensitivity of SEDline for Seizure Detection

    Time frame: Within 72 hours after cardiac arrest

    Sensitivity measured the percentage of seizures identified by the SEDline in cases those were identified as seizures by the conventional EEG.

  2. Specificity

    Time frame: Within 72 hours after cardiac arrest

    Specificity measured the percentage of seizure-negative identified by the SEDline in cases those were identified as seizure-negative by the conventional EEG.

  3. Positive Predictive Value

    Time frame: Within 72 hours after cardiac arrest

    Positive predictive value measured the percentage of seizures identified by the conventional EEG in cases those were identified as seizures by the SEDline.

  4. Negative Predictive Value

    Time frame: Within 72 hours after cardiac arrest

    Negative predictive value measured the percentage of seizure-negative identified by the conventional EEG in cases those were identified as seizure-negative by the SEDline.

  5. Area Under Receiver Operating Characteristics Curve (AUC) of SEDline for Seizure Detection

    Time frame: Within 72 hours after cardiac arrest

    The Area under receiver operating characteristics curve (AUC) of SEDline represents the accuracy of the SEDline to detect seizures compared with the conventional EEG.

Sponsors and collaborators

Lead sponsor

Gil Joon Suh

Other

Collaborators

  • Humed Co., Ltd
  • Masimo Corporation

Registry information

Official study title

Trial of Device for Seizure Detection Using SEDline During Therapeutic Hypothermia in Cardiac Arrest Victims

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 20, 2013
Registry last updated
Mar 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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