Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2026-01-11 @ 4:17 PM
Study NCT ID:
NCT02924805
Status:
COMPLETED
Last Update Posted:
2016-10-05
First Post:
2016-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Telemedical Versus Conventional Emergency Care of Hypertensive Emergencies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000096003', 'term': 'Hypertensive Crisis'}], 'ancestors': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 331}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-03', 'studyFirstSubmitDate': '2016-10-03', 'studyFirstSubmitQcDate': '2016-10-03', 'lastUpdatePostDateStruct': {'date': '2016-10-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Analysis of administered antihypertensive agents', 'timeFrame': '2 hours'}, {'measure': 'context specific quality of medical history and documentation', 'timeFrame': '2 hours', 'description': 'Analysis of medical history and vital parameter documentation completeness'}], 'primaryOutcomes': [{'measure': 'Blood pressure difference between initial contact and emergency room handover', 'timeFrame': '2 hours'}], 'secondaryOutcomes': [{'measure': 'Difference of heart rate between initial contact and emergency room handover', 'timeFrame': '2 hours'}, {'measure': 'Magnitude of blood pressure reduction using categories', 'timeFrame': '2 hours', 'description': 'To measure guideline adherence blood pressure (BP) reductions were evaluated with four categories: no BP reduction, reduction \\<= 25%, reduction \\>25-30%, reduction \\> 30% (BP difference between initial contact and emergency room handover)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypertensive Emergency', 'Hypertensive Urgency']}, 'descriptionModule': {'briefSummary': 'Comparison of telemedical prehospital emergency care and conventional on-scene physician based care of hypertensive emergencies and urgencies. The adherence to current Guidelines should be researched.', 'detailedDescription': 'Telemedically guided cases of hypertensive emergencies (april 2014 - March 2015) and urgencies are compared with a historical control group of conventional emergency medical service physician care on-scene for these scenarios. The historical control group is a time period prior to implementation of the telemedicine system and after a research project with a precursor telemedicine system. No telemedical support but only conventional on-scene EMS physician care was available (November 2013 - March 2014).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients whith a prehospital diagnosis of hypertensive emergency or urgency', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* prehospital diagnosis of hypertensive emergency of hypertensive urgency\n\nExclusion Criteria:\n\nPrehospital diagnoses of:\n\n* pulmonary edema\n* aortic dissection\n* acute coronary syndrome\n* acute stroke\n* acute respiratory insufficiency'}, 'identificationModule': {'nctId': 'NCT02924805', 'briefTitle': 'Telemedical Versus Conventional Emergency Care of Hypertensive Emergencies', 'organization': {'class': 'OTHER', 'fullName': 'RWTH Aachen University'}, 'officialTitle': 'Telemedical Versus Conventional Emergency Care of Hypertensive Emergencies and Urgencies', 'orgStudyIdInfo': {'id': 'TECH'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Telemedicine group', 'description': 'Cases of hypertensive emergencies and urgencies in which the prehospital emergency care was performed by on-scene paramedics, guided by a qualified physician in a teleconsultation center.', 'interventionNames': ['Other: Telemedical care']}, {'label': 'Control group', 'description': 'Historical cases of of hypertensive emergencies and urgencies in which the prehospital emergency care was carried out by on-scene emergency medical service physicians (conventional care).'}], 'interventions': [{'name': 'Telemedical care', 'type': 'OTHER', 'description': 'Telemedically guided care based on a standard operating procedure', 'armGroupLabels': ['Telemedicine group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52074', 'city': 'Aachen', 'country': 'Germany', 'facility': 'University Hospital Aachen', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}], 'overallOfficials': [{'name': 'Jörg Ch Brokmann, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Aachen, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RWTH Aachen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}