Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-25 @ 5:14 PM
Study NCT ID:
NCT01104103
Status:
TERMINATED
Last Update Posted:
2012-08-20
First Post:
2010-04-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effectiveness Study of the BOA(R)-Constricting IV Band
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Richard.N.Bradley@uth.tmc.edu', 'phone': '713-500-7878', 'title': 'Dr. Richard Bradley', 'organization': 'The University of Texas Health Science Center at Houston'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'There was a significant disparity between subjective opinion and objective results. Nurses and paramedics who used the BOA were uniformly positive in their comments about the device.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'BOA(R)', 'description': 'Nurse or paramedic uses the BOA(R)-Constricting IV Band to attempt placement of an upper extremity IV in an adult', 'otherNumAtRisk': 243, 'otherNumAffected': 0, 'seriousNumAtRisk': 243, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard Care', 'description': 'Nurse or paramedic uses standard IV starting technique in the upper extremity of adults', 'otherNumAtRisk': 224, 'otherNumAffected': 0, 'seriousNumAtRisk': 224, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BOA(R)', 'description': 'Nurse or paramedic uses the BOA(R)-Constricting IV Band to attempt placement of an upper extremity IV in an adult'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Nurse or paramedic uses standard IV starting technique in the upper extremity of adults'}], 'classes': [{'categories': [{'measurements': [{'value': '198', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'five minutes (average)', 'description': 'This outcome will measure self-reported success at starting the peripheral intravenous lines in the upper extremity of adults. Success is defined as an IV line through which blood may be aspirated and flushes freely without evidence of fluid extravasation. To be successful, the IV must be placed within a maximum of three attempts. We will report the number and percentage of patients with successful for both therapies.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'First Stick Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BOA(R)', 'description': 'Nurse or paramedic uses the BOA(R)-Constricting IV Band to attempt placement of an upper extremity IV in an adult'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Nurse or paramedic uses standard IV starting technique in the upper extremity of adults'}], 'classes': [{'categories': [{'measurements': [{'value': '167', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Five minutes (average)', 'description': 'This outcome will report the number of IV attempts as defined by the tip of the needle piercing the skin. The results for each IV attempt will be an ordinal number between one and three. We will compare the number and percentage of patients in each group (1, 2, or 3 sticks) between the two therapies.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BOA(R)', 'description': 'Nurse or paramedic uses the BOA(R)-Constricting IV Band to attempt placement of an upper extremity IV in an adult'}, {'id': 'FG001', 'title': 'Standard Care', 'description': 'Nurse or paramedic uses standard IV starting technique in the upper extremity of adults'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '243'}, {'groupId': 'FG001', 'numSubjects': '224'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '243'}, {'groupId': 'FG001', 'numSubjects': '224'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "We randomly assigned the 26 healthcare providers (16 paramedics, 10 nurses) to use either the BOA® Constricting Band or elastic tourniquets for all IV attempts during the study. Thirteen subjects were in each group. Those that were randomized to the BOA group received training in the use of the device according to the manufacturer's instructions."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'BG000'}, {'value': '224', 'groupId': 'BG001'}, {'value': '467', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'BOA(R)', 'description': 'Nurse or paramedic uses the BOA(R)-Constricting IV Band to attempt placement of an upper extremity IV in an adult'}, {'id': 'BG001', 'title': 'Standard Care', 'description': 'Nurse or paramedic uses standard IV starting technique in the upper extremity of adults'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Categorical', 'classes': [{'title': '<=18 years', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Between 18 and 65 years', 'categories': [{'measurements': [{'value': '175', 'groupId': 'BG000'}, {'value': '178', 'groupId': 'BG001'}, {'value': '353', 'groupId': 'BG002'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.17', 'spread': '19.54', 'groupId': 'BG000'}, {'value': '46.78', 'spread': '19.01', 'groupId': 'BG001'}, {'value': '48.53', 'spread': '19.34', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '122', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '226', 'groupId': 'BG002'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '115', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '228', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '243', 'groupId': 'BG000'}, {'value': '224', 'groupId': 'BG001'}, {'value': '467', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 467}}, 'statusModule': {'whyStopped': 'Pre-determined stopping point met with signficant difference between intervention and control groups.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-16', 'studyFirstSubmitDate': '2010-04-09', 'resultsFirstSubmitDate': '2012-07-16', 'studyFirstSubmitQcDate': '2010-04-13', 'lastUpdatePostDateStruct': {'date': '2012-08-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-07-16', 'studyFirstPostDateStruct': {'date': '2010-04-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success', 'timeFrame': 'five minutes (average)', 'description': 'This outcome will measure self-reported success at starting the peripheral intravenous lines in the upper extremity of adults. Success is defined as an IV line through which blood may be aspirated and flushes freely without evidence of fluid extravasation. To be successful, the IV must be placed within a maximum of three attempts. We will report the number and percentage of patients with successful for both therapies.'}], 'secondaryOutcomes': [{'measure': 'First Stick Success', 'timeFrame': 'Five minutes (average)', 'description': 'This outcome will report the number of IV attempts as defined by the tip of the needle piercing the skin. The results for each IV attempt will be an ordinal number between one and three. We will compare the number and percentage of patients in each group (1, 2, or 3 sticks) between the two therapies.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Catheterization, Peripheral', 'Disposable Equipment', 'Emergency Medical Technicians', 'Emergency Nursing'], 'conditions': ['Catheterization, Peripheral']}, 'referencesModule': {'references': [{'pmid': '16280942', 'type': 'BACKGROUND', 'citation': 'Black KJ, Pusic MV, Harmidy D, McGillivray D. Pediatric intravenous insertion in the emergency department: bevel up or bevel down? Pediatr Emerg Care. 2005 Nov;21(11):707-11. doi: 10.1097/01.pec.0000186422.77140.1f.'}, {'pmid': '965227', 'type': 'BACKGROUND', 'citation': 'Meier J, Schreier E. Human plasma levels of some anti-migraine drugs. Headache. 1976 Jul;16(3):96-104. doi: 10.1111/j.1526-4610.1976.hed1603096.x. No abstract available.'}, {'pmid': '16157191', 'type': 'BACKGROUND', 'citation': 'Jacobson AF, Winslow EH. Variables influencing intravenous catheter insertion difficulty and failure: an analysis of 339 intravenous catheter insertions. Heart Lung. 2005 Sep-Oct;34(5):345-59. doi: 10.1016/j.hrtlng.2005.04.002.'}, {'pmid': '17554524', 'type': 'BACKGROUND', 'citation': 'Lapostolle F, Catineau J, Garrigue B, Monmarteau V, Houssaye T, Vecci I, Treoux V, Hospital B, Crocheton N, Adnet F. Prospective evaluation of peripheral venous access difficulty in emergency care. Intensive Care Med. 2007 Aug;33(8):1452-7. doi: 10.1007/s00134-007-0634-y. Epub 2007 Jun 7.'}, {'pmid': '3172305', 'type': 'BACKGROUND', 'citation': 'Pons PT, Moore EE, Cusick JM, Brunko M, Antuna B, Owens L. Prehospital venous access in an urban paramedic system--a prospective on-scene analysis. J Trauma. 1988 Oct;28(10):1460-3. doi: 10.1097/00005373-198810000-00009.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the BOA(R)-Constricting IV Band is superior to standard methods for starting an IV.', 'detailedDescription': 'We will test the hypothesis that paramedics and nurses treating in- and out-of-hospital patients with a BOA(R)-Constricting IV Band, compared to paramedics using standard treatment, will have better success rates for peripheral IV access.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Paramedics employed by the City of Houston or nurses employed by Memorial Hermann Hospital - Texas Medical Center\n* Agree to participate through written consent process\n\nExclusion Criteria:\n\n* City of Houston paramedics and Memorial Hermann Hospital - Texas Medical Center nurses who do not provide written informed consent to participate'}, 'identificationModule': {'nctId': 'NCT01104103', 'briefTitle': 'Effectiveness Study of the BOA(R)-Constricting IV Band', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'The BOA(R)-Constricting IV Band: A Single Blind, Cohort Study of Effectiveness', 'orgStudyIdInfo': {'id': 'NAR UTH 001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BOA(R)', 'description': 'Nurse or paramedic uses the BOA(R)-Constricting IV Band to attempt placement of an upper extremity IV in an adult', 'interventionNames': ['Device: BOA(R)-Constricting IV Band']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard care', 'description': 'Nurse or paramedic uses standard IV starting technique in the upper extremity of adults', 'interventionNames': ['Device: Standard elastic constricting band']}], 'interventions': [{'name': 'BOA(R)-Constricting IV Band', 'type': 'DEVICE', 'otherNames': ['NSN: 6515-01-537-2611'], 'description': "Device applied in accordance with manufacturer's instructions", 'armGroupLabels': ['BOA(R)']}, {'name': 'Standard elastic constricting band', 'type': 'DEVICE', 'otherNames': ['elastic constricting band (Cardinal Health; McGaw Park, IL)'], 'description': 'Standard therapy', 'armGroupLabels': ['Standard care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77002', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Fire Department', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030-1501', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Memorial Hermann Hospital-Texas Medical Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Richard N Bradley, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'collaborators': [{'name': 'North American Rescue, LLC', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor - Emergency Medicine', 'investigatorFullName': 'Richard Bradley', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}