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| Name | Class |
|---|---|
| Masimo Corporation | INDUSTRY |
| Humed Co., Ltd | UNKNOWN |
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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.
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
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.
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
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Frontal 4 channel EEG | Device | Simultaneous conventional EEG and SEDline monitoring for 30 minutes during and after therapeutic hypothermia |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Specificity |
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Inclusion Criteria:
Exclusion Criteria:
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Comatose cardiac arrest survivors admitted to a 12-bed emergency intensive care unit of Seoul National University Hospital, Seoul, Republic of Korea.
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| Name | Affiliation | Role |
|---|---|---|
| Gil Joon Suh, Prof | Seoul National University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Emergency Medicine, Seoul National University Hospital | Seoul | 110-744 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14296835 | Background | 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. doi: 10.1016/0013-4694(65)90075-1. No abstract available. | |
| 20920227 | Background | 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. |
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After discussion with Masimo
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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.
Form 31/12/2014 to 19/08/2016 In the Emergency Intensive Care Unit of Seoul National University Hospital
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| ID | Title | Description |
|---|---|---|
| FG000 | Frontal 4 Channel EEG | Consecutive comatose patients admitted to the emergency ICU for postresuscitation care following successful cardiopulmonary resuscitation after nontraumatic cardiac arrest. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | percentage of seizures | Within 72 hours after cardiac arrest |
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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Since the SEDline system provides 4-channel-processed EEG monitoring in the frontal area, focal seizures could not be detected and spatial localization of the seizure might be difficult.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pf. Gil Joon Suh | Seoul National University Hospital | 82-2-2072-2196 | suhgil@snu.ac.kr |
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| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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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 | 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 | 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 | 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 |
| 23284064 | Background | 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. |
| Protocol Violation |
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| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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. |
|
|
| 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. | Posted | Number | percentage of seizure (+) | 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. | Posted | Number | percentage of seizure (-) | 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. | Posted | Number | percentage of seizure (+) | 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. | Posted | Number | percentage of seizure (-) | 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. | Posted | Number | probability | Within 72 hours after cardiac arrest |
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| 17 |
| 39 |
| 0 |
| 39 |
| 0 |
| 39 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |