Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 10:51 PM
Study NCT ID:
NCT03405467
Status:
COMPLETED
Last Update Posted:
2018-01-23
First Post:
2017-11-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
10-years Nationwide Alpine Accidents in Austria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005627', 'term': 'Frostbite'}, {'id': 'D015168', 'term': 'Lightning Injuries'}], 'ancestors': [{'id': 'D000067390', 'term': 'Cold Injury'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D004556', 'term': 'Electric Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-19', 'studyFirstSubmitDate': '2017-11-28', 'studyFirstSubmitQcDate': '2018-01-19', 'lastUpdatePostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of persons suffered an accident in Alpine Mountains in Austria', 'timeFrame': '2005-2015', 'description': 'The number of persons (n/year) which suffered one of the specified accidents.'}, {'measure': 'Gender of persons suffered an accident in Alpine Mountains in Austria', 'timeFrame': '2005-2015', 'description': 'Gender male/female or non specified which suffered one of the specified accidents.'}, {'measure': 'Mortality of persons suffered an accident in Alpine Mountains in Austria', 'timeFrame': '2005-2015', 'description': 'Number of persons deceased (deceased/n per year) which suffered one of the specified accidents.'}], 'secondaryOutcomes': [{'measure': 'Number of pattern like injured patients treated in University Hospital of Innsbruck, a major tertiary trauma center in western Austria.', 'timeFrame': '2005-2015', 'description': '(n/year) treated in University Hospital of Innsbruck'}, {'measure': 'Gender of pattern like injured patients treated in University Hospital of Innsbruck, a major tertiary trauma center in western Austria.', 'timeFrame': '2005-2015', 'description': 'male/female, unspecified treated in University Hospital of Innsbruck'}, {'measure': 'Injury severity score (ISS) of pattern like injured patients treated in University Hospital of Innsbruck, a major tertiary trauma center in western Austria.', 'timeFrame': '2005-2015', 'description': 'Injury severity score of suffered injury (ISS=AIS\\*AIS)'}, {'measure': 'Abbreviated Injury severity scale (AIS) of pattern like injured patients treated in University Hospital of Innsbruck, a major tertiary trauma center in western Austria.', 'timeFrame': '2005-2015', 'description': 'Abreviated Injury severity scale of suffered injury (1-6 points; scale - minor, moderate, serious, severe, critial, maximum)'}, {'measure': 'Type of evacuation and mortality', 'timeFrame': '2005-2015', 'description': 'Type of evacuation (terrestrial, helicopter, combined terrestrial and helicopter) and the mortality for each group (deceased/n per year)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alpine Accident', 'Frostbite', 'Cardiopulmonary Arrest With Successful Resuscitation', 'Lightning Injuries', 'Flight Accident']}, 'referencesModule': {'references': [{'pmid': '30201016', 'type': 'DERIVED', 'citation': 'Strohle M, Wallner B, Lanthaler M, Rauch S, Brugger H, Paal P. Lightning accidents in the Austrian alps - a 10-year retrospective nationwide analysis. Scand J Trauma Resusc Emerg Med. 2018 Sep 10;26(1):74. doi: 10.1186/s13049-018-0543-9.'}]}, 'descriptionModule': {'briefSummary': "This observational study intends to analyze the characteristic of specific accidents happened in Austrian's mountainous regions. The mechanisms of accidents which are evaluated are lightning accidents, cardiopulmonary resuscitation with or without automated external defibrillator, frostbite injuries, accidents with flying vehicle (e.g. paraglider, hang-glider…).", 'detailedDescription': "The data are collected retrospectively from the database of Austrian alpine police force. These data are analyzed. The information from this database (scene of accident, weather, daytime…) is compared to secondary data collected from the University Hospital of Innsbruck. The comparison of both databases was approved by the Austrian Data Protection Agency. The goal of the study is to give detailed information of circumstances leading to accident and give medical information of the patient's condition and his outcome."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All Patients in the two databases eligible for the searched injury patterns.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Person suffering the injury searched for;\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03405467', 'briefTitle': '10-years Nationwide Alpine Accidents in Austria', 'organization': {'class': 'OTHER', 'fullName': 'Medical University Innsbruck'}, 'officialTitle': 'A Retrospective 10-years Nationwide Observational Study of Alpine Accidents - Flight Accidents, CPR and AED in Alpine Region, Frostbite Injuries and Lightning Strike', 'orgStudyIdInfo': {'id': 'AN4757 315/4.4'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'lightning accident', 'description': 'patients suffered injuries due to lightning strike', 'interventionNames': ['Other: general and specific data']}, {'label': 'frostbite', 'description': 'patients suffered injuries due to local hypothermia leading to frostbite injuries', 'interventionNames': ['Other: general and specific data']}, {'label': 'cpr and aed', 'description': 'patients suffered cardiac arrest in alpine region treated with or without automated external defibrillatior', 'interventionNames': ['Other: general and specific data']}, {'label': 'flight accident', 'description': 'patients suffered injuries due to use of a flying vehicle in mountainous regions.', 'interventionNames': ['Other: general and specific data']}], 'interventions': [{'name': 'general and specific data', 'type': 'OTHER', 'description': 'General and specific data collected', 'armGroupLabels': ['cpr and aed', 'flight accident', 'frostbite', 'lightning accident']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6020', 'city': 'Innsbruck', 'country': 'Austria', 'facility': 'General and Surgical Critical Care Medicine, Medical University of Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}], 'overallOfficials': [{'name': 'Peter Paal, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital of Barmherzige Brüder Salzburg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University Innsbruck', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator Dr', 'investigatorFullName': 'Mathias Ströhle', 'investigatorAffiliation': 'Medical University Innsbruck'}}}}