Seizure Detection Using SEDline During Therapeutic Hypothermia in Cardiac Arrest Victims

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01946802

Enrollment

Registered

2013-09-20

Start date

2014-12-31

Completion date

2016-10-31

Last updated

2021-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrest

Keywords

Heart arrest, Cardiopulmonary resuscitation, Hypothermia induced, Seizures, Electroencephalography

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).

Interventions

DEVICEFrontal 4 channel EEG

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Seizure-positive and Seizure-negative That Were Correctly Classified by the SEDline in All Evaluated Cases	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

Measure	Time frame	Description
Sensitivity of SEDline for Seizure Detection	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.
Specificity	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.
Positive Predictive Value	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.
Negative Predictive Value	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.
Area Under Receiver Operating Characteristics Curve (AUC) of SEDline for Seizure Detection	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.

Countries

South Korea

Participant flow

Recruitment details

Form 31/12/2014 to 19/08/2016 In the Emergency Intensive Care Unit of Seoul National University Hospital

Pre-assignment details

53 were screened for eligibility. 9 were excluded (4 Advanced directives to withhold or withdraw life-sustaining treatment, 3 No informed consent, 1 Known intracranial pathology, and 1 Visible generalized seizure). 44 provided informed consents. 5 were withdrawn(see baseline characteristics). Finally 39 patients were enrolled.

Participants by arm

Arm	Count
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. Frontal 4 channel EEG: Simultaneous conventional EEG and SEDline monitoring for 30 minutes during and after therapeutic hypothermia	39
Total	39

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Combined septic shock	1
Overall Study	Death	1
Overall Study	Protocol Violation	1
Overall Study	Withdrawal by Subject	2

Baseline characteristics

Characteristic	Frontal 4 Channel EEG
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	18 Participants
Age, Categorical Between 18 and 65 years	21 Participants
Age, Continuous	60 years
Region of Enrollment Korea, Republic of	39 participants
Sex: Female, Male Female	14 Participants
Sex: Female, Male Male	25 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	17 / 39
other Total, other adverse events	0 / 39
serious Total, serious adverse events	0 / 39

Outcome results

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.