Seizure Detection Using SEDline During Therapeutic Hypothermia in Cardiac Arrest Victims

Cardiac Arrest Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01946802
• Other study ID #: H-1303-013-470
• Status: Completed
• Start date: December 2014
• Est. completion date: October 2016

Study information

• Verified date: March 2021
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest
• Hypothermia
• Seizures

Intervention

Device:
• Frontal 4 channel EEG
Simultaneous conventional EEG and SEDline monitoring for 30 minutes during and after therapeutic hypothermia

Locations

Country	Name	City	State
Korea, Republic of	Department of Emergency Medicine, Seoul National University Hospital	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Gil Joon Suh	Humed Co., Ltd, Masimo Corporation

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Seizure-positive and Seizure-negative That Were Correctly Classified by the SEDline in All Evaluated Cases	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	Sensitivity of SEDline for Seizure Detection	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
Secondary	Specificity	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
Secondary	Positive Predictive Value	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
Secondary	Negative Predictive Value	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
Secondary	Area Under Receiver Operating Characteristics Curve (AUC) of SEDline for Seizure Detection	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