Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2026-03-03 @ 6:44 PM
Study NCT ID:
NCT04114760
Status:
COMPLETED
Last Update Posted:
2020-10-22
First Post:
2019-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Timely Acquirement of 12-lead ECG Using Patchy-type Wireless Device by Emergency Medical Technician in Ambulance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002637', 'term': 'Chest Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-21', 'studyFirstSubmitDate': '2019-09-30', 'studyFirstSubmitQcDate': '2019-10-02', 'lastUpdatePostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time from 12-lead ECG device application starting to sending ECG result to hospital.', 'timeFrame': 'through study completion, an average of 2 month', 'description': 'comparison of interval from the start of 12-lead ECG device application to complete of ECG result sending'}], 'secondaryOutcomes': [{'measure': 'Usability of patchy-type wireless ECG device.', 'timeFrame': 'survey collecting through study completion an average of 2 month', 'description': 'System Usability Scale survey of patchy-type wireless ECG device'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['12-lead electrocardiography', 'Emergency medical technician', 'chest pain', 'wireless technology', 'simulation study'], 'conditions': ['Chest Pain', 'Electrocardiography']}, 'referencesModule': {'references': [{'pmid': '36099010', 'type': 'DERIVED', 'citation': 'Yoo S, Chang H, Kim T, Yoon H, Hwang SY, Shin TG, Sim MS, Jo IJ, Choi JH, Cha WC. Intervention in the Timeliness of Two Electrocardiography Types for Patients in the Emergency Department With Chest Pain: Randomized Controlled Trial. Interact J Med Res. 2022 Sep 13;11(2):e36335. doi: 10.2196/36335.'}, {'pmid': '33792550', 'type': 'DERIVED', 'citation': 'Yoon S, Kim T, Roh T, Chang H, Hwang SY, Yoon H, Shin TG, Sim MS, Jo IJ, Cha WC. Twelve-Lead Electrocardiogram Acquisition With a Patchy-Type Wireless Device in Ambulance Transport: Simulation-Based Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Apr 1;9(4):e24142. doi: 10.2196/24142.'}]}, 'descriptionModule': {'briefSummary': "In this study, the investigators compare timely acquirement and effectiveness of 12-lead ECG using patchy-type wireless versus using defibrillator which contain ECG examination function in ambulance.\n\nThe purpose of this study is to determine the difference of timely acquirement of 12-lead ECG using two different systems and the difference of efficiency of ECG examination in ambulance between two groups.\n\nThe participants in this simulation study were divided randomly into 2 groups :\n\nGroup A is performing an ECG examination on mock patient using defibrillator which contained 12-lead ECG checking function. And take a 15 minutes wash out period. After the wash out period, group A subject performing an ECG examination using patchy-type wireless device.\n\nGroup B subject is performing an ECG examination on mock patient using patchy-type wireless device first, and take a 15 minutes wash out period. After the wash out period, group B performing an ECG examination using defibrillator which contain 12-lead ECG function.\n\nBoth group's ECG examination is performing in the ambulance."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Who have a certification of Emergency Medical Technician in korea and have a nurse license in korea.\n* who currently engaged of emergency medical dispatch.\n\nExclusion Criteria:\n\n* A subject who did not agree with this study'}, 'identificationModule': {'nctId': 'NCT04114760', 'briefTitle': 'Timely Acquirement of 12-lead ECG Using Patchy-type Wireless Device by Emergency Medical Technician in Ambulance', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Timely Acquirement of 12-lead Electrocardiography Using Patchy-type Wireless Device by Emergency Medical Technicians in Ambulance ; A Simulation Study', 'orgStudyIdInfo': {'id': '2019-04-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A : defibrillator ECG to patchy-type ECG', 'description': 'Group A subject will performing ECG examination to a mock patient in the ambulance.\n\nFirst ECG performance will be using defibrillator which contain 12-lead ECG checking function. And taking a 15 minutes wash out period. Second ECG performance after wash out period, will be using patchy-type wireless device.\n\nwhen ECG examination performance ended, survey of patchy-type wireless ECG device usability will be collect.', 'interventionNames': ['Device: defibrillator ECG']}, {'type': 'EXPERIMENTAL', 'label': 'Group B : patchy-type ECG to defibrillator ECG', 'description': 'Group B subject will performing ECG examination to a mock patient in the ambulance.\n\nFirst ECG performance will be using patchy-type wireless device.\n\nAnd taking a 15 minutes wash out period. Second ECG performance after wash out period, will be using defibrillator which contain 12-lead ECG checking function.\n\nwhen ECG examination performance ended, survey of patchy-type wireless ECG device usability will be collect.', 'interventionNames': ['Device: patchy-type wireless ECG']}], 'interventions': [{'name': 'patchy-type wireless ECG', 'type': 'DEVICE', 'description': 'This device consists of a single patchy and save the ECG result as a Potable Document Format. Also can transfer to hospital using wifi-network.', 'armGroupLabels': ['Group B : patchy-type ECG to defibrillator ECG']}, {'name': 'defibrillator ECG', 'type': 'DEVICE', 'description': 'This device is essential equipment in ambulance. For 12-lead ECG examination the connector need to replace for specific cable.', 'armGroupLabels': ['Group A : defibrillator ECG to patchy-type ECG']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06351', 'city': 'Seoul', 'state': 'Gangnam', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'tearim kim, doctoral', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'samsumg medical center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}