Ignite Creation Date:
2025-12-24 @ 5:07 PM
Ignite Modification Date:
2025-12-25 @ 9:08 PM
Study NCT ID:
NCT01780350
Status:
COMPLETED
Last Update Posted:
2015-02-27
First Post:
2012-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Assessment of the Implementation of the ResQGARD® Impedance Threshold Device by the San Antonio Fire Department
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'wamplerd@uthscsa.edu', 'phone': '210.567.7598', 'title': 'David Wampler, PhD', 'organization': 'University of Texas Health Science Center San Antonio'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'ResQGARD ITD', 'description': 'Subjects receive a ResQGARD ITD.\n\nResQGARD ITD: Patients eligible for the device will receive the ResQGARD attached to a facemask or mouthpiece. The patient will use the device, provided it is tolerated, until their blood pressure is stabilized as determined by EMS personnel.', 'otherNumAtRisk': 200, 'otherNumAffected': 0, 'seriousNumAtRisk': 200, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Systolic Blood Pressure From Baseline (Before ITD Use)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ResQGARD ITD', 'description': 'Subjects receive a ResQGARD ITD.\n\nResQGARD ITD: Patients eligible for the device will receive the ResQGARD attached to a facemask or mouthpiece. The patient will use the device, provided it is tolerated, until their blood pressure is stabilized as determined by EMS personnel.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.9', 'spread': '20.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During device use, up to 1 hour', 'description': 'Determining whether the application of an ITD will provide improvement in systolic blood pressure in subjects with hypotension in patients being treated by San Antonio EMS when compared to baseline.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Tolerability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ResQGARD ITD', 'description': 'Subjects receive a ResQGARD ITD.\n\nResQGARD ITD: Patients eligible for the device will receive the ResQGARD attached to a facemask or mouthpiece. The patient will use the device, provided it is tolerated, until their blood pressure is stabilized as determined by EMS personnel.'}], 'classes': [{'title': 'easy', 'categories': [{'measurements': [{'value': '115', 'groupId': 'OG000'}]}]}, {'title': 'moderate', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}, {'title': 'difficult', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'not answered', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Duration of device use, up to 1 hour', 'description': 'Determine patient tolerability of the device while breathing through it. This is subjectively measured by the paramedic administering the device based on verbal reporting from the patient and paramedic estimation of the patient response to the device.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ResQGARD ITD', 'description': 'Subjects receive a ResQGARD ITD.\n\nResQGARD ITD: Patients eligible for the device will receive the ResQGARD attached to a facemask or mouthpiece. The patient will use the device, provided it is tolerated, until their blood pressure is stabilized as determined by EMS personnel.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '200'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '200'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'ResQGARD ITD', 'description': 'Subjects receive a ResQGARD ITD.\n\nResQGARD ITD: Patients eligible for the device will receive the ResQGARD attached to a facemask or mouthpiece. The patient will use the device, provided it is tolerated, until their blood pressure is stabilized as determined by EMS personnel.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.8', 'spread': '18.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '92', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '108', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '200', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-12', 'studyFirstSubmitDate': '2012-07-19', 'resultsFirstSubmitDate': '2015-02-12', 'studyFirstSubmitQcDate': '2013-01-30', 'lastUpdatePostDateStruct': {'date': '2015-02-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-02-12', 'studyFirstPostDateStruct': {'date': '2013-01-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-02-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Systolic Blood Pressure From Baseline (Before ITD Use)', 'timeFrame': 'During device use, up to 1 hour', 'description': 'Determining whether the application of an ITD will provide improvement in systolic blood pressure in subjects with hypotension in patients being treated by San Antonio EMS when compared to baseline.'}], 'secondaryOutcomes': [{'measure': 'Tolerability', 'timeFrame': 'Duration of device use, up to 1 hour', 'description': 'Determine patient tolerability of the device while breathing through it. This is subjectively measured by the paramedic administering the device based on verbal reporting from the patient and paramedic estimation of the patient response to the device.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acute Hypotension']}, 'descriptionModule': {'briefSummary': 'This study is attached to a comprehensive quality assurance/quality improvement (QA/QI) program conducted by the Office of the medical director, and is designed to contribute to generalizable knowledge to determine effectiveness and tolerability of an FDA approved Impedance Threshold Device (ITD) device in a large urban emergency medical service (EMS) system. The cohort will comprise a convenience sample of patients that are being treated by EMS for a hypotensive emergency.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults between the ages of 18-120 years\n* presenting to EMS with or development of Hypotension during EMS interaction\n* treated by EMS with the ITD\n\nExclusion Criteria:\n\n* pediatric patients\n* patients that do not present with or develop hypotension\n* patients who the ITD will not form a secure seal due to anatomical abnormalities'}, 'identificationModule': {'nctId': 'NCT01780350', 'briefTitle': 'Assessment of the Implementation of the ResQGARD® Impedance Threshold Device by the San Antonio Fire Department', 'organization': {'class': 'INDUSTRY', 'fullName': 'Advanced Circulatory Systems'}, 'orgStudyIdInfo': {'id': 'W81XWH-BAA-11-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ResQGARD ITD', 'description': 'Subjects receive a ResQGARD ITD.', 'interventionNames': ['Device: ResQGARD ITD']}], 'interventions': [{'name': 'ResQGARD ITD', 'type': 'DEVICE', 'description': 'Patients eligible for the device will receive the ResQGARD attached to a facemask or mouthpiece. The patient will use the device, provided it is tolerated, until their blood pressure is stabilized as determined by EMS personnel.', 'armGroupLabels': ['ResQGARD ITD']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Advanced Circulatory Systems', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}