Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-30 @ 4:41 AM
Study NCT ID:
NCT01310504
Status:
COMPLETED
Last Update Posted:
2012-08-17
First Post:
2011-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of the FAST (Focused Abdominal Scan for Trauma) Scan by Paramedics in Mass Casualty Incidents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-16', 'studyFirstSubmitDate': '2011-03-07', 'studyFirstSubmitQcDate': '2011-03-07', 'lastUpdatePostDateStruct': {'date': '2012-08-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the use of the ultra sound and FAST scans in a simulation of a mass causality incident by paramedics for accuracy and speed', 'timeFrame': 'up to 1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Mass Casualty']}, 'descriptionModule': {'briefSummary': 'Initially a group of paramedics will be trained to perform FAST (Focused Abdominal Scan for Trauma) scans. The paramedics will then enter a simulated mass causality incident and triage patients. Volunteers in the study will include peritoneal dialysis patients ("non stable") and non-peritoneal dialysis patients ("stable"). They will use the ultrasound to perform FAST scans on the patients to determine which subjects are "stable" and which are "unstable" patients. They will record which patients they consider need transport first. This data will be used to evaluate accuracy and speed of the FAST scan. When the paramedic identifies free fluid within the volunteer, they will be able to make the decision to upgrade these patients and ultimately transport them more quickly. The paramedics will be evaluated for time and accuracy with the FAST scan.', 'detailedDescription': 'Ultrasound and the FAST (Focused Abdominal Scan for Trauma) scan is currently being used in the Emergency Department to help evaluate trauma patients. In the field a paramedic will use the START (Simple Triage Rapid Treatment) triage procedure to evaluate many patients and to help decide which patients are more critical and therefore need to be transported first. This study aims to create a mass casualty environment through the use of 10 volunteers who are on peritoneal dialysis and 10 patients who are not.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nParamedic - at least one year in the field, physically able to perform the test\n\nPatients:\n\n* (10)peritoneal dialysis patient that are able to leave dialysate in abdominal cavity for the duration of the test\n* (10) subjects not on peritoneal dialysis who are available for the duration of the test\n\nExclusion Criteria:\n\n* Under 18 years of age'}, 'identificationModule': {'nctId': 'NCT01310504', 'briefTitle': 'The Use of the FAST (Focused Abdominal Scan for Trauma) Scan by Paramedics in Mass Casualty Incidents', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ascension Health'}, 'officialTitle': 'The Use of the FAST Scan by Paramedics in Mass Casualty Incidents', 'orgStudyIdInfo': {'id': 'ME 10 0050'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Non peritoneal dialysis patient', 'interventionNames': ['Procedure: SonoSite Ultrasound']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Peritoneal dialysis patient', 'interventionNames': ['Procedure: SonoSite Ultrasound']}], 'interventions': [{'name': 'SonoSite Ultrasound', 'type': 'PROCEDURE', 'description': "Will be moulaged to resemble a peritoneal dialysis patient. Paramedics will scan the abdomen and determine it there's fluid within.", 'armGroupLabels': ['Non peritoneal dialysis patient']}, {'name': 'SonoSite Ultrasound', 'type': 'PROCEDURE', 'description': "Paramedics will scan the abdomen and determine it there's fluid within.", 'armGroupLabels': ['Peritoneal dialysis patient']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48439', 'city': 'Grand Blanc', 'state': 'Michigan', 'country': 'United States', 'facility': 'Genesys Regional Medical Center', 'geoPoint': {'lat': 42.92753, 'lon': -83.62995}}], 'overallOfficials': [{'name': 'James A Cusser, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ascension Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ascension Health', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'J. Andrew Cusser', 'investigatorAffiliation': 'Ascension Health'}}}}