Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2026-01-11 @ 2:56 PM
Study NCT ID:
NCT01946802
Status:
COMPLETED
Last Update Posted:
2021-03-23
First Post:
2013-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Seizure Detection Using SEDline During Therapeutic Hypothermia in Cardiac Arrest Victims
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D012640', 'term': 'Seizures'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'suhgil@snu.ac.kr', 'phone': '82-2-2072-2196', 'title': 'Pf. Gil Joon Suh', 'organization': 'Seoul National University Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': '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.'}}, 'adverseEventsModule': {'timeFrame': '30 days', 'eventGroups': [{'id': 'EG000', 'title': 'Frontal 4 Channel EEG', 'description': '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.\n\nFrontal 4 channel EEG: Simultaneous conventional EEG and SEDline monitoring for 30 minutes during and after therapeutic hypothermia', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 0, 'seriousNumAtRisk': 39, 'deathsNumAffected': 17, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Seizure-positive and Seizure-negative That Were Correctly Classified by the SEDline in All Evaluated Cases', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Frontal 4 Channel EEG', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 72 hours after cardiac arrest', 'description': '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.', 'unitOfMeasure': 'percentage of seizures', 'reportingStatus': 'POSTED', 'populationDescription': '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.\n\nFinally 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.'}, {'type': 'SECONDARY', 'title': 'Sensitivity of SEDline for Seizure Detection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Frontal 4 Channel EEG', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 72 hours after cardiac arrest', 'description': 'Sensitivity measured the percentage of seizures identified by the SEDline in cases those were identified as seizures by the conventional EEG.', 'unitOfMeasure': 'percentage of seizure (+)', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Specificity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Frontal 4 Channel EEG', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 72 hours after cardiac arrest', 'description': 'Specificity measured the percentage of seizure-negative identified by the SEDline in cases those were identified as seizure-negative by the conventional EEG.', 'unitOfMeasure': 'percentage of seizure (-)', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Positive Predictive Value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Frontal 4 Channel EEG', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 72 hours after cardiac arrest', 'description': 'Positive predictive value measured the percentage of seizures identified by the conventional EEG in cases those were identified as seizures by the SEDline.', 'unitOfMeasure': 'percentage of seizure (+)', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Negative Predictive Value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Frontal 4 Channel EEG', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 72 hours after cardiac arrest', 'description': '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.', 'unitOfMeasure': 'percentage of seizure (-)', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Area Under Receiver Operating Characteristics Curve (AUC) of SEDline for Seizure Detection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Frontal 4 Channel EEG', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 72 hours after cardiac arrest', 'description': 'The Area under receiver operating characteristics curve (AUC) of SEDline represents the accuracy of the SEDline to detect seizures compared with the conventional EEG.', 'unitOfMeasure': 'probability', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Frontal 4 Channel EEG', 'description': 'Consecutive comatose patients admitted to the emergency ICU for postresuscitation care following successful cardiopulmonary resuscitation after nontraumatic cardiac arrest.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Combined septic shock', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Form 31/12/2014 to 19/08/2016 In the Emergency Intensive Care Unit of Seoul National University Hospital', 'preAssignmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Frontal 4 Channel EEG', 'description': '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.\n\nFrontal 4 channel EEG: Simultaneous conventional EEG and SEDline monitoring for 30 minutes during and after therapeutic hypothermia'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000', 'lowerLimit': '34', 'upperLimit': '83'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Korea, Republic of', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '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.\n\nFinally 39 patients were enrolled in this study.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-21', 'studyFirstSubmitDate': '2013-09-11', 'resultsFirstSubmitDate': '2016-10-14', 'studyFirstSubmitQcDate': '2013-09-16', 'lastUpdatePostDateStruct': {'date': '2021-03-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-21', 'studyFirstPostDateStruct': {'date': '2013-09-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Seizure-positive and Seizure-negative That Were Correctly Classified by the SEDline in All Evaluated Cases', 'timeFrame': 'Within 72 hours after cardiac arrest', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Sensitivity of SEDline for Seizure Detection', 'timeFrame': 'Within 72 hours after cardiac arrest', 'description': 'Sensitivity measured the percentage of seizures identified by the SEDline in cases those were identified as seizures by the conventional EEG.'}, {'measure': 'Specificity', 'timeFrame': 'Within 72 hours after cardiac arrest', 'description': 'Specificity measured the percentage of seizure-negative identified by the SEDline in cases those were identified as seizure-negative by the conventional EEG.'}, {'measure': 'Positive Predictive Value', 'timeFrame': 'Within 72 hours after cardiac arrest', 'description': 'Positive predictive value measured the percentage of seizures identified by the conventional EEG in cases those were identified as seizures by the SEDline.'}, {'measure': 'Negative Predictive Value', 'timeFrame': 'Within 72 hours after cardiac arrest', 'description': '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.'}, {'measure': 'Area Under Receiver Operating Characteristics Curve (AUC) of SEDline for Seizure Detection', 'timeFrame': 'Within 72 hours after cardiac arrest', 'description': 'The Area under receiver operating characteristics curve (AUC) of SEDline represents the accuracy of the SEDline to detect seizures compared with the conventional EEG.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Heart arrest', 'Cardiopulmonary resuscitation', 'Hypothermia induced', 'Seizures', 'Electroencephalography'], 'conditions': ['Cardiac Arrest']}, 'referencesModule': {'references': [{'pmid': '14296835', 'type': 'BACKGROUND', '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. doi: 10.1016/0013-4694(65)90075-1. No abstract available.'}, {'pmid': '20920227', 'type': 'BACKGROUND', '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.'}, {'pmid': '23284064', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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).\n\n 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.\n\n During therapeutic hypothermia, their core temperatures are maintained from 32 to 34°C.\n\n 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.\n2. Conventional EEG Conventional EEG is conducted for 30 minutes at\n\n 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.\n3. 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.\n\n The presence of seizure activity in SEDline is determined by the definition\n 1. Electrographic seizure: rhythmic discharge or spike and wave pattern with definite evolution in frequency, location, or morphology lasting several seconds.\n 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\n4. 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\n5. Gold standard The presence of Seizure identified in conventional EEG.\n6. 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Comatose cardiac arrest survivors admitted to a 12-bed emergency intensive care unit of Seoul National University Hospital, Seoul, Republic of Korea.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* Cardiac arrest is defined as cessation of cardiac mechanical activity, confirmed by the absence of a detectable pulse, unresponsiveness, and apnea.\n\nExclusion Criteria:\n\n* Age \\< 18 years old\n* Contraindication to therapeutic hypothermia: active life-threatening bleeding, septic shock, or refractory fatal arrhythmia..\n* Intracranial pathology including hemorrhage or tumor\n* Visible generalized seizure before the study enrollment\n* Advanced directives to withdraw life-sustaining treatment\n* No informed consent'}, 'identificationModule': {'nctId': 'NCT01946802', 'briefTitle': 'Seizure Detection Using SEDline During Therapeutic Hypothermia in Cardiac Arrest Victims', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Trial of Device for Seizure Detection Using SEDline During Therapeutic Hypothermia in Cardiac Arrest Victims', 'orgStudyIdInfo': {'id': 'H-1303-013-470'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Frontal 4 channel EEG', 'description': '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.', 'interventionNames': ['Device: Frontal 4 channel EEG']}], 'interventions': [{'name': 'Frontal 4 channel EEG', 'type': 'DEVICE', 'otherNames': ['SEDline, Masimo corporation'], 'description': 'Simultaneous conventional EEG and SEDline monitoring for 30 minutes during and after therapeutic hypothermia', 'armGroupLabels': ['Frontal 4 channel EEG']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Emergency Medicine, Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Gil Joon Suh, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'After discussion with Masimo'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gil Joon Suh', 'class': 'OTHER'}, 'collaborators': [{'name': 'Masimo Corporation', 'class': 'INDUSTRY'}, {'name': 'Humed Co., Ltd', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Gil Joon Suh', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}