Trial Outcomes & Findings for Seizure Detection Using SEDline During Therapeutic Hypothermia in Cardiac Arrest Victims (NCT NCT01946802)

NCT ID: NCT01946802

Last Updated: 2021-03-23

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 39 participants
• Primary outcome timeframe: Within 72 hours after cardiac arrest
• Results posted on: 2021-03-23

Participant Flow

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

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consent, 1 Known intracranial pathology, and 1 Visible generalized seizure). 44 provided informed consents. 5 were withdrawn(see baseline characteristics).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.

Participant milestones

Measure	Frontal 4 Channel EEG Consecutive comatose patients admitted to the emergency ICU for postresuscitation care following successful cardiopulmonary resuscitation after nontraumatic cardiac arrest.
Overall Study STARTED	44
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	Frontal 4 Channel EEG Consecutive comatose patients admitted to the emergency ICU for postresuscitation care following successful cardiopulmonary resuscitation after nontraumatic cardiac arrest.
Overall Study Death	1
Overall Study Withdrawal by Subject	2
Overall Study Combined septic shock	1
Overall Study Protocol Violation	1

Baseline Characteristics

Seizure Detection Using SEDline During Therapeutic Hypothermia in Cardiac Arrest Victims

Baseline characteristics by cohort

Measure	Frontal 4 Channel EEG n=39 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants
Age, Categorical >=65 years	18 Participants n=5 Participants
Age, Continuous	60 years n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants
Region of Enrollment Korea, Republic of	39 participants n=5 Participants

PRIMARY outcome

Timeframe: Within 72 hours after cardiac arrest

Population: 44 provided informed consents. Among them 5 were withdrawn. 1 death before EEG, 2 relative withdrew patient, 1 combined septic shock, and 1 patient did not perform EEG within 72 hours. Finally 39 patients were enrolled in this study. Conventional EEG (gold standard for seizure detection) and SEDline monitoring were conducted simultaneously for 30 minutes at During therapeutic hypothermia and rewarming.

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.

Outcome measures

Measure	Frontal 4 Channel EEG n=39 Participants 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.
Percentage of Seizure-positive and Seizure-negative That Were Correctly Classified by the SEDline in All Evaluated Cases	100 percentage of seizures

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Frontal 4 Channel EEG n=39 Participants 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.
Sensitivity of SEDline for Seizure Detection	100 percentage of seizure (+)

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Frontal 4 Channel EEG n=39 Participants 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.
Specificity	100 percentage of seizure (-)

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Frontal 4 Channel EEG n=39 Participants 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.
Positive Predictive Value	100 percentage of seizure (+)

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Frontal 4 Channel EEG n=39 Participants 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.
Negative Predictive Value	100 percentage of seizure (-)

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Frontal 4 Channel EEG n=39 Participants 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.
Area Under Receiver Operating Characteristics Curve (AUC) of SEDline for Seizure Detection	1.00 probability

Adverse Events

Frontal 4 Channel EEG

Serious events: 0 serious events

Other events: 0 other events

Deaths: 17 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pf. Gil Joon Suh

Seoul National University Hospital

Phone: 82-2-2072-2196

Email: suhgil@snu.ac.kr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place