Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-01-03 @ 4:54 AM
Study NCT ID:
NCT01058967
Status:
COMPLETED
Last Update Posted:
2019-04-18
First Post:
2010-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Evaluation of Aeromedical EMS Ultrasound in Major Trauma Victims
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-16', 'studyFirstSubmitDate': '2010-01-27', 'studyFirstSubmitQcDate': '2010-01-27', 'lastUpdatePostDateStruct': {'date': '2019-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome for this study is to determine if the aeromedical prehospital providers are able to accurately and rapidly perform and interpret eFAST exams in major trauma victims.', 'timeFrame': '6 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Code III trauma (highest acuity)', 'Life Flight aeromedical ambulance service'], 'conditions': ['Major Trauma Patients']}, 'referencesModule': {'references': [{'pmid': '25281177', 'type': 'DERIVED', 'citation': 'Press GM, Miller SK, Hassan IA, Alade KH, Camp E, Junco DD, Holcomb JB. Prospective evaluation of prehospital trauma ultrasound during aeromedical transport. J Emerg Med. 2014 Dec;47(6):638-45. doi: 10.1016/j.jemermed.2014.07.056. Epub 2014 Oct 1.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the use of ultrasound by aeromedical prehospital providers.', 'detailedDescription': 'This study will be divided into three parts. The first portion involves the education/inservices of the aeromedical prehospital providers to document the knowledge and skills necessary to perform and interpret eFAST exams using ultrasound pre hospitalization.\n\nThe second portion involves testing the logistics of utilization of prehospital ultrasound. Data will be collected by the participating aeromedical prehospital providers to rate the durability of the equipment, difficulty in preforming the eFAST exam, interference with other actions and ability of retention of images.\n\nThe third portion will involve the aeromedical prehospital providers performing the eFAST exam using the ultrasound prehospital and comparing their findings with the gold standard exam, CT scan, while patient is in the emergency department.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have experienced a major traumatic injury highest acuity trauma activation (Code III status) transported from scene to hospital via Life Flight (hospital aeroambulance service)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Code 3 trauma activation Admitted directly from scene Transported via Life Flight (aeromedical ambulance)\n\nExclusion Criteria:\n\n* transfer from outside hospital'}, 'identificationModule': {'nctId': 'NCT01058967', 'briefTitle': 'Prospective Evaluation of Aeromedical EMS Ultrasound in Major Trauma Victims', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'UTHSC-H Proposal for Prospective Evaluation of Aeromedical EMS Ultrasound in Major Trauma Victims.', 'orgStudyIdInfo': {'id': 'HSC-MS-08-0085'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'major trauma victims', 'description': 'Code 3 patients (highest acuity) admitted to hospital via air ambulance service'}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Memorial Hermann Hospital - Medical Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Greg Press, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UTHSC-Houston'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'collaborators': [{'name': 'SonoSite, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Sara K Miller', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}