Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2026-02-23 @ 1:11 AM
Study NCT ID:
NCT02010151
Status:
COMPLETED
Last Update Posted:
2020-03-30
First Post:
2013-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dispatcher-Activated Neighborhood Access Defibrillation and Cardiopulmonary Resuscitation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058687', 'term': 'Out-of-Hospital Cardiac Arrest'}], 'ancestors': [{'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sy2376@gmail.com', 'phone': '+82-10-9269-2376', 'title': 'Dr. Sun Young Lee', 'organization': 'Seoul National University Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': "It's not randomized trial, it's before-after study."}}, 'adverseEventsModule': {'timeFrame': 'from hospital arrival (from ambulance) to the hospital or ED discharge within 2 month (All patients have different time frame because all patients have different admission period)', 'eventGroups': [{'id': 'EG000', 'title': 'Conventional Dispatcher CPR', 'description': 'patients enrolled in period that conventional dispatcher CPR was provided to the patients.', 'otherNumAtRisk': 1498, 'deathsNumAtRisk': 1498, 'otherNumAffected': 0, 'seriousNumAtRisk': 1498, 'deathsNumAffected': 1363, 'seriousNumAffected': 1363}, {'id': 'EG001', 'title': 'NAD-CPR', 'description': 'patients enrolled in period that NAD-CPR was provided to the patients.', 'otherNumAtRisk': 1696, 'deathsNumAtRisk': 1696, 'otherNumAffected': 0, 'seriousNumAtRisk': 1696, 'deathsNumAffected': 1480, 'seriousNumAffected': 1480}], 'seriousEvents': [{'term': 'death', 'notes': 'death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1498, 'numEvents': 1363, 'numAffected': 1363}, {'groupId': 'EG001', 'numAtRisk': 1696, 'numEvents': 1480, 'numAffected': 1480}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Surviving at Hospital Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1498', 'groupId': 'OG000'}, {'value': '1696', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Dispatcher CPR', 'description': 'patients enrolled in period that conventional dispatcher CPR was provided to the patients.'}, {'id': 'OG001', 'title': 'NAD-CPR', 'description': 'patients enrolled in period that NAD-CPR was provided to the patients.'}], 'classes': [{'categories': [{'measurements': [{'value': '135', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'discharge time from first admission from emergency department within 2 month', 'description': 'we compared the survival to discharge rate between before intervention period and intervention period.\n\nSurvival to discharge checked at the discharge point of hospital.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Study population excluding exclusion criteria'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Pre-Hospital Return of Spontaneous Circulation (ROSC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1498', 'groupId': 'OG000'}, {'value': '1696', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Dispatcher CPR', 'description': 'patients enrolled in period that conventional dispatcher CPR was provided to the patients.'}, {'id': 'OG001', 'title': 'NAD-CPR', 'description': 'patients enrolled in period that NAD-CPR was provided to the patients.'}], 'classes': [{'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'hospital arriving time from ambulance within 2 hours', 'description': 'we compared the Pre-hospital return of spontaneous circulation (ROSC) rate between before intervention period and intervention period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Good Neurological Recovery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1498', 'groupId': 'OG000'}, {'value': '1696', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Dispatcher CPR', 'description': 'patients enrolled in period that conventional dispatcher CPR was provided to the patients.'}, {'id': 'OG001', 'title': 'NAD-CPR', 'description': 'patients enrolled in period that NAD-CPR was provided to the patients.'}], 'classes': [{'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'discharge time from first admission from emergency department within 2 month', 'description': 'Cerebral performance category 1 or 2 is defined as good neurological recovery. we compared the good neurological recovery rate between before intervention period and intervention period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Conventional Dispatcher Assisted CPR', 'description': 'patients enrolled in period that conventional dispatcher assisted CPR was provided to patient (January 2013 to April 2015).\n\nbaseline EMS assessed OHCA: 2,418\n\n* Adult\n* presumed cardiac etiology\n* Resuscitation attempted\n* Not witnessed by EMS provider\n* Eligible for analysis Final population : 1498'}, {'id': 'FG001', 'title': 'NAD-CPR', 'description': 'patients enrolled in period that NAD-CPR was provided to patient (May 2015 to December 2017)\n\nbaseline EMS assessed OHCA: 2,611\n\n* Adult\n* presumed cardiac etiology\n* Resuscitation attempted\n* Not witnessed by EMS provider\n* Eligible for analysis Final population : 1,696 (TM sent: 598)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'January 2013 to December 2017', 'groupId': 'FG000', 'numSubjects': '1498'}, {'comment': 'January 2013 to December 2017', 'groupId': 'FG001', 'numSubjects': '1696'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Text message (TM) sent: 0', 'groupId': 'FG000', 'numSubjects': '1498'}, {'comment': 'TM sent: 598', 'groupId': 'FG001', 'numSubjects': '1696'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1498', 'groupId': 'BG000'}, {'value': '1696', 'groupId': 'BG001'}, {'value': '3194', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Conventional Dispatcher CPR', 'description': 'patients enrolled in period that conventional dispatcher CPR was provided to the patients.'}, {'id': 'BG001', 'title': 'NAD-CPR', 'description': 'patients enrolled in period that NAD-CPR was provided to the patients.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1498', 'groupId': 'BG000'}, {'value': '1696', 'groupId': 'BG001'}, {'value': '3194', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000', 'lowerLimit': '58', 'upperLimit': '80'}, {'value': '72', 'groupId': 'BG001', 'lowerLimit': '59', 'upperLimit': '80'}, {'value': '72', 'groupId': 'BG002', 'lowerLimit': '58', 'upperLimit': '80'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1498', 'groupId': 'BG000'}, {'value': '1696', 'groupId': 'BG001'}, {'value': '3194', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '532', 'groupId': 'BG000'}, {'value': '577', 'groupId': 'BG001'}, {'value': '1109', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '966', 'groupId': 'BG000'}, {'value': '1119', 'groupId': 'BG001'}, {'value': '2085', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'South Korea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1498', 'groupId': 'BG000'}, {'value': '1696', 'groupId': 'BG001'}, {'value': '3194', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1498', 'groupId': 'BG000'}, {'value': '1696', 'groupId': 'BG001'}, {'value': '3194', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'TM sent', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1498', 'groupId': 'BG000'}, {'value': '1696', 'groupId': 'BG001'}, {'value': '3194', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '598', 'groupId': 'BG001'}, {'value': '598', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'TM means text message sent to the volunteers. In Seoul, dispatcher asked two key questions regarding altered mental status and abnormal breathing for suspected arrest according to the DA-CPR protocol. When a cardiac arrest was suspected, the dispatchers pushed a button to send a short text message containing the location of the arrest and nearest PAD to registered volunteers within the same geographic neighborhood.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'in the before/after intervention period (January 2013 to April 2015, May 2015 to December 2017), Those cases without an attempted resuscitation effort, cases that were witnessed by EMS providers or those that occurred at a nursing home or medical facility were excluded.\n\n\\* both arm participants are not double counted.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-05-23', 'size': 54216, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-02-08T23:05', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3194}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-16', 'studyFirstSubmitDate': '2013-12-09', 'resultsFirstSubmitDate': '2019-04-17', 'studyFirstSubmitQcDate': '2013-12-09', 'lastUpdatePostDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-16', 'studyFirstPostDateStruct': {'date': '2013-12-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Surviving at Hospital Discharge', 'timeFrame': 'discharge time from first admission from emergency department within 2 month', 'description': 'we compared the survival to discharge rate between before intervention period and intervention period.\n\nSurvival to discharge checked at the discharge point of hospital.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Pre-Hospital Return of Spontaneous Circulation (ROSC)', 'timeFrame': 'hospital arriving time from ambulance within 2 hours', 'description': 'we compared the Pre-hospital return of spontaneous circulation (ROSC) rate between before intervention period and intervention period.'}, {'measure': 'Number of Participants With Good Neurological Recovery', 'timeFrame': 'discharge time from first admission from emergency department within 2 month', 'description': 'Cerebral performance category 1 or 2 is defined as good neurological recovery. we compared the good neurological recovery rate between before intervention period and intervention period.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Out of Hospital Cardiac Arrest', 'Cardiopulmonary Resuscitation', 'dispatch', 'emergency medicine'], 'conditions': ['Out of Hospital Cardiac Arrest']}, 'referencesModule': {'references': [{'pmid': '30902689', 'type': 'DERIVED', 'citation': 'Lee SY, Shin SD, Lee YJ, Song KJ, Hong KJ, Ro YS, Lee EJ, Kong SY. Text message alert system and resuscitation outcomes after out-of-hospital cardiac arrest: A before-and-after population-based study. Resuscitation. 2019 May;138:198-207. doi: 10.1016/j.resuscitation.2019.01.045. Epub 2019 Mar 19.'}]}, 'descriptionModule': {'briefSummary': 'The hypothesis of this study is Dispatcher-Activated Neighborhood Access Defibrillation and Cardiopulmonary Resuscitation (NAD-CPR) would improve survival of out-of-hospital cardiac arrest (OHCA).', 'detailedDescription': "Out-of-hospital cardiac arrest (OHCA) is a major health problem, occurring in about 1 in 1,500 adults in the developed countries each year. Although layperson CPR and defibrillation are crucial components of chain of survival, layperson CPR rate and it's quality is low and public-access defibrillation (PAD) program is not cost-effective.If trained bystanders can know the information of occurrence of OHCA and nearest place for automated external defibrillator (AED) at the same time by dispatch center, these neighborhoods could run and give high quality CPR and early defibrillation. If this protocol ,Dispatcher-Activated Neighborhood Access Defibrillation and Cardiopulmonary Resuscitation(NAD-CPR), is introduced to community, it may improve survival of OHCA."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all OHCA with presumed cardiac etiology more than 15 years old\n* assessed by emergency medical service (EMS) providers dispatched by dispatch center\n* dispatcher detected OHCA patients\n\nExclusion Criteria:\n\n* OHCA with non-cardiac etiology\n* prolonged cardiac arrest with a suspected duration more than 30 minutes\n* cases with rigor mortis or rivor mortis, decapitated or decomposed body\n* Non detected cases by dispatcher'}, 'identificationModule': {'nctId': 'NCT02010151', 'briefTitle': 'Dispatcher-Activated Neighborhood Access Defibrillation and Cardiopulmonary Resuscitation', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Population Based Intervention Trial of Dispatcher-Activated Neighborhood Access Defibrillation and Cardiopulmonary Resuscitation', 'orgStudyIdInfo': {'id': 'SNUEMS201309'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NAD-CPR', 'description': 'When dispatcher detects a patient with OHCA, the dispatcher activates trained neighborhoods by informing events nearby using short message service via cellular phone. The neighborhood within geographically accessible area who could perform effective CPR and defibrillation would be alerted with event of OHCA and the nearest AED.', 'interventionNames': ['Other: NAD-CPR']}, {'type': 'NO_INTERVENTION', 'label': 'Conventional dispatcher assisted CPR', 'description': 'When dispatcher detects OHCA, they instruct the caller with CPR instructions. This is conventional dispatcher assisted CPR performed in Seoul.'}], 'interventions': [{'name': 'NAD-CPR', 'type': 'OTHER', 'description': 'When Dispatcher detects OHCA, short message service (SMS)about the OHCA event and information about the location of nearest AED is sent to trained laypersons within geographically accessible area.', 'armGroupLabels': ['NAD-CPR']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul Metropolitan City', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Sang Do Shin, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Korean Center for Disease Control and Prevention', 'class': 'OTHER_GOV'}, {'name': 'Seoul Metropolitan Government Health and Welfare Office', 'class': 'UNKNOWN'}, {'name': 'Seoul Metropolitan Fire and Disaster Headquater', 'class': 'UNKNOWN'}, {'name': 'Korea Association for Safety Community', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated Professor', 'investigatorFullName': 'Sang Do Shin', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}