Seizure Detection Using SEDline During Therapeutic Hypothermia in Cardiac Arrest Victims

March 21, 2021 updated by: Gil Joon Suh

Trial of Device for 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Actual)

39

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Department of Emergency Medicine, Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 Names:
  • SEDline, Masimo corporation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within 72 hours after cardiac arrest

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within 72 hours after cardiac arrest
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.
Within 72 hours after cardiac arrest
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.
Within 72 hours after cardiac arrest
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.
Within 72 hours after cardiac arrest
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.
Within 72 hours after cardiac arrest

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gil Joon Suh

Collaborators

Masimo Corporation
Humed Co., Ltd

Investigators

  • Study Director: Gil Joon Suh, Prof, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (ACTUAL)

October 1, 2016

Study Completion (ACTUAL)

October 1, 2016

Study Registration Dates

First Submitted

September 11, 2013

First Submitted That Met QC Criteria

September 16, 2013

First Posted (ESTIMATE)

September 20, 2013

Study Record Updates

Last Update Posted (ACTUAL)

March 23, 2021

Last Update Submitted That Met QC Criteria

March 21, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-1303-013-470

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

After discussion with Masimo

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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