Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-02-23 @ 1:11 AM
Study NCT ID:
NCT02527694
Status:
COMPLETED
Last Update Posted:
2019-01-15
First Post:
2015-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
CPR Quality Between Flexible Stretcher and Standard Stretcher in OHCA
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': 'soyeon.kong@gmail.com', 'phone': '82220724412', 'title': 'So Yeon Kong', 'organization': 'Seoul National University Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'During the 6 weeks of before-phase and 2 weeks of after-phase for a total of 2 months', 'eventGroups': [{'id': 'EG000', 'title': 'Standard Stretcher Group', 'description': 'Standard strecher for manual compression on supine position', 'otherNumAtRisk': 29, 'otherNumAffected': 0, 'seriousNumAtRisk': 29, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Reducible Stretcher Group', 'description': "We manufactured a stretcher that hinged at multiple points to be reduced to fit into small elevators with a patient on board. The stretcher can be used to transport patients without cardiac arrest in the same manner as a standard stretcher. In cases of cardiac arrest, the upper mattress of the stretcher could be removed to install the mechanical compression device. The stretcher has additional sidebars that can be used to attach and lock mechanical CPR devices that are commercially available in Korea. The patient' legs were elevated with V shape body position through knee flection and hip flection on accessory steel bar when the patients are being transporting to avoid decrease of venous return by leg-down. A l0ad-distributing band-type mechanical compression device, the AutoPulse® (ZOLL Medical, Chelmsford, MA, USA), was used for this study.", 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Comparison of Percentage of Chest Compression Fraction Between Before- and After-phase Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Stretcher Cart Group', 'description': 'Standard strecher for manual compression on supine position'}, {'id': 'OG001', 'title': 'Flexible Stretcher Cart Group', 'description': "We manufactured a stretcher that hinged at multiple points to be reduced to fit into small elevators with a patient on board. The stretcher can be used to transport patients without cardiac arrest in the same manner as a standard stretcher. In cases of cardiac arrest, the upper mattress of the stretcher could be removed to install the mechanical compression device. The stretcher has additional sidebars that can be used to attach and lock mechanical CPR devices that are commercially available in Korea. The patient' legs were elevated with V shape body position through knee flection and hip flection on accessory steel bar when the patients are being transporting to avoid decrease of venous return by leg-down. A l0ad-distributing band-type mechanical compression device, the AutoPulse® (ZOLL Medical, Chelmsford, MA, USA), was used for this study."}], 'classes': [{'categories': [{'measurements': [{'value': '80.1', 'groupId': 'OG000', 'lowerLimit': '68.0', 'upperLimit': '85.2'}, {'value': '85.2', 'groupId': 'OG001', 'lowerLimit': '83.4', 'upperLimit': '86.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'During the total prehospital resuscitation time', 'description': 'Chest compression fraction was calculated as proportion of CPR time spent providing compressions.', 'unitOfMeasure': 'Percentage of chest compression fraction', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'CPR Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Stretcher Group', 'description': 'Standard strecher for manual compression on supine position'}, {'id': 'OG001', 'title': 'Reducible Stretcher Group', 'description': "We manufactured a stretcher that hinged at multiple points to be reduced to fit into small elevators with a patient on board. The stretcher can be used to transport patients without cardiac arrest in the same manner as a standard stretcher. In cases of cardiac arrest, the upper mattress of the stretcher could be removed to install the mechanical compression device. The stretcher has additional sidebars that can be used to attach and lock mechanical CPR devices that are commercially available in Korea. The patient' legs were elevated with V shape body position through knee flection and hip flection on accessory steel bar when the patients are being transporting to avoid decrease of venous return by leg-down. A l0ad-distributing band-type mechanical compression device, the AutoPulse® (ZOLL Medical, Chelmsford, MA, USA), was used for this study."}], 'classes': [{'categories': [{'measurements': [{'value': '909', 'groupId': 'OG000', 'lowerLimit': '594', 'upperLimit': '1013'}, {'value': '1131', 'groupId': 'OG001', 'lowerLimit': '974', 'upperLimit': '1262'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'During total prehospital resuscitation', 'unitOfMeasure': 'seconds', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Flexible Stretcher Cart Group', 'description': 'Patients in this group will be transported on the new flexible stretcher cart and receive mechanical CPR during transport to the hospital. The intervention will be given during elevator transport (if applicable) as well as in the moving ambulance.\n\nFlexible EMS stretcher cart: The flexible stretcher cart is an innovative EMS stretcher cart built to be flexible to fit in smaller spaces such as elevators. The flexible stretcher bends at the hip joint as well as at the knee joint, so that the patient can be put in head-up position at 30 degrees elevation with elevated legs.\n\nmechanical CPR'}, {'id': 'FG001', 'title': 'Standard Stretcher Cart Group', 'description': 'Patients in this group will be transported on the standard stretcher cart and receive manual CPR during transport to the hospital. The resuscitation protocol will follow the current standard protocol used by the EMS providers.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '8'}]}]}], 'recruitmentDetails': 'Adult OHCAs transported by five ambulances in a metropolitan area with a population of 3.5 million (many of whom lived in high-rise buildings) from September to October (before-phase) and November to December (afterphase) in 2015 were collected.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard Stretcher Cart Group', 'description': 'Standard strecher for manual compression on supine position'}, {'id': 'BG001', 'title': 'Flexible Stretcher Cart Group', 'description': "We manufactured a stretcher that hinged at multiple points to be reduced to fit into small elevators with a patient on board. The stretcher can be used to transport patients without cardiac arrest in the same manner as a standard stretcher. In cases of cardiac arrest, the upper mattress of the stretcher could be removed to install the mechanical compression device. The stretcher has additional sidebars that can be used to attach and lock mechanical CPR devices that are commercially available in Korea. The patient' legs were elevated with V shape body position through knee flection and hip flection on accessory steel bar when the patients are being transporting to avoid decrease of venous return by leg-down. A l0ad-distributing band-type mechanical compression device, the AutoPulse® (ZOLL Medical, Chelmsford, MA, USA), was used for this study."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000', 'lowerLimit': '58', 'upperLimit': '73'}, {'value': '66', 'groupId': 'BG001', 'lowerLimit': '60', 'upperLimit': '74'}, {'value': '66', 'groupId': 'BG002', 'lowerLimit': '58', 'upperLimit': '74'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'South Korea', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'During the before-phase, 29 OHCAs were treated and transported by EMS crews. After serial exclusion, 21 patients were eligible for the final analysis. During the afterphase, 20 OHCAs were eligible for enrollment. After serial exclusion, 10 cardiac arrests received mechanical chest compressions on reducible stretchers during hospital transport'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-31', 'studyFirstSubmitDate': '2015-08-06', 'resultsFirstSubmitDate': '2018-01-15', 'studyFirstSubmitQcDate': '2015-08-18', 'lastUpdatePostDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-03-16', 'studyFirstPostDateStruct': {'date': '2015-08-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of Percentage of Chest Compression Fraction Between Before- and After-phase Groups', 'timeFrame': 'During the total prehospital resuscitation time', 'description': 'Chest compression fraction was calculated as proportion of CPR time spent providing compressions.'}], 'secondaryOutcomes': [{'measure': 'CPR Duration', 'timeFrame': 'During total prehospital resuscitation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Emergency medical services', 'Resuscitation'], 'conditions': ['Out-of-hospital Cardiac Arrest']}, 'descriptionModule': {'briefSummary': 'This study aims to compare the quality of emergency medical services cardiopulmonary resuscitation between flexible stretcher and standard stretcher during ambulance transport to hospital among out-of-hospital cardiac arrest patients.', 'detailedDescription': 'Background: Cardiopulmonary resuscitation (CPR) during ambulance transport in Asia has been known to be ineffective for quality and unsafe for emergency medical services(EMS)providers. Small elevators in high rise buildings are the most serious barriers to provide high quality CPR due to too long stretcher cart to enter in the elevators. We developed flexible stretcher cart to be safely used in small elevator through reducing the length of the stretcher. This study aims to compare the quality of EMS CPR between flexible stretcher and standard stretcher during transport to hospital.\n\nMethod:\n\nThis is a before and after-trial in a metropolis EMS. Study targets are adult out-of-hospital cardiac arrest (OHCA), excluding evident death cases, pregnancy, DNR cases, and too big or too small body size for stretcher cart or mechanical CPR devices. In the before period, the standard stretcher will be used for manual CPR using standard CPR protocol. In the after period, the flexible stretcher will be used with mechanical CPR devices after 3 cycles of standard manual CPR. Individual and Utstein risk factors will be collected. Main outcomes are no-flow fraction (NFF) measured by defibrillators (X-series) and safety will be measured on mechanical error, transportation error, patient injury and EMS provider injury. Sample size were 24 cases for before (12 cases) and after (12 cases) trial from 80% power and 0.05 of alpha error for expecting 20% quality difference (30% NFF inflexible stretcher and 50% NFF in standard stretcher)\n\nExpected impact:\n\nThe study will be expected to find the benefit of flexible stretcher cart during CPR in small elevators. This findings will contribute to revise the Asian EMS protocol for improving quality of CPR.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All EMS-assessed OHCA in (3-4) selected districts in Seoul\n* 18 years or older of age\n\nExclusion Criteria:\n\n* Do-Not-Resuscitation cases or OHCA occurring in result of terminal diseases\n* Signs of evident death (decapitation, evident livor mortis or rigor mortis)\n* Pregnant\n* Physique too large for mechanical CPR device application\n* Chest deformation or injury\n* EMS CPR quality not assessed by the defibrillator\n* Return of spontaneous circulation (ROSC) before scene departure\n* Cardiac arrest cases during transport'}, 'identificationModule': {'nctId': 'NCT02527694', 'acronym': 'ASIA-CPR', 'briefTitle': 'CPR Quality Between Flexible Stretcher and Standard Stretcher in OHCA', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Comparison of Quality of Cardiopulmonary Resuscitation Between Flexible Stretcher and Standard Stretcher in Out-of-Hospital Cardiac Arrest: Ambulance Stretcher Innovation of Asian CPR (ASIA-CPR) Trial', 'orgStudyIdInfo': {'id': 'SNUH-EM-2015-2P'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Flexible EMS Stretcher Cart Group', 'description': 'Patients in this group will be transported on the new flexible EMS stretcher cart and receive mechanical CPR during transport to the hospital. The intervention will be given during elevator transport (if applicable) as well as in the moving ambulance.', 'interventionNames': ['Device: Flexible EMS stretcher cart', 'Device: mechanical CPR']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Stretcher Cart Group', 'description': 'Patients in this group will be transported on the standard stretcher cart and receive manual CPR during transport to the hospital. The resuscitation protocol will follow the current standard protocol used by the EMS providers.'}], 'interventions': [{'name': 'Flexible EMS stretcher cart', 'type': 'DEVICE', 'description': 'The flexible EMS stretcher cart is an innovative EMS stretcher cart built to be flexible to fit in smaller spaces such as elevators. The flexible stretcher bends at the hip joint as well as at the knee joint, so that the patient can be put in head-up position at 30 degrees elevation with elevated legs.', 'armGroupLabels': ['Flexible EMS Stretcher Cart Group']}, {'name': 'mechanical CPR', 'type': 'DEVICE', 'armGroupLabels': ['Flexible EMS Stretcher Cart Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', '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'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Sang Do Shin', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}