Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2025-12-27 @ 9:31 PM
Study NCT ID:
NCT01676350
Status:
COMPLETED
Last Update Posted:
2022-03-23
First Post:
2012-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Intraosseous Access in the Emergency Department for Patients With Failed Attempts at Intravenous Access: A Randomized Trial Examining Resource Utilization and Patient Satisfaction
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bbecker2@wellspan.org', 'phone': '717-851-2223', 'title': 'Brent Becker', 'organization': 'WellSpan York Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Standard of Care', 'description': 'If you are assigned to this group, ultrasound-guided IV will be used to obtain vascular access.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '&Apos;IO Access Using EZ-IO®', 'description': 'If you are assigned to this group, you will receive an IO line in the humeral head of the shoulder. IO lines are placed using an FDA-approved device called an EZ-IO®.\n\nIO access using EZ-IO®: IO line placed using an FDA-approved device called an EZ-IO®.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Successful Placement of a Functioning USGIV/IO', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care', 'description': 'If you are assigned to this group, ultrasound-guided IV will be used to obtain vascular access.'}, {'id': 'OG001', 'title': '&Apos;IO Access Using EZ-IO®', 'description': 'If you are assigned to this group, you will receive an IO line in the humeral head of the shoulder. IO lines are placed using an FDA-approved device called an EZ-IO®.\n\nIO access using EZ-IO®: IO line placed using an FDA-approved device called an EZ-IO®.'}], 'classes': [{'categories': [{'measurements': [{'value': '163.7', 'spread': '177.9', 'groupId': 'OG000'}, {'value': '67.3', 'spread': '98.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at time of vascular access', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Successful Placements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care', 'description': 'If you are assigned to this group, ultrasound-guided IV will be used to obtain vascular access.'}, {'id': 'OG001', 'title': 'IO Access Using EZ-IO®', 'description': 'If you are assigned to this group, you will receive an IO line in the humeral head of the shoulder. IO lines are placed using an FDA-approved device called an EZ-IO®.\n\nIO access using EZ-IO®: IO line placed using an FDA-approved device called an EZ-IO®.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at time of vascular access', 'unitOfMeasure': 'successful placements', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard of Care', 'description': 'If you are assigned to this group, ultrasound-guided IV will be used to obtain vascular access.'}, {'id': 'FG001', 'title': '&Apos;IO Access Using EZ-IO®', 'description': 'If you are assigned to this group, you will receive an IO line in the humeral head of the shoulder. IO lines are placed using an FDA-approved device called an EZ-IO®.\n\nIO access using EZ-IO®: IO line placed using an FDA-approved device called an EZ-IO®.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard of Care', 'description': 'Standard of care'}, {'id': 'BG001', 'title': 'IO Access', 'description': 'IO access'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-21', 'studyFirstSubmitDate': '2012-08-28', 'resultsFirstSubmitDate': '2017-10-31', 'studyFirstSubmitQcDate': '2012-08-29', 'lastUpdatePostDateStruct': {'date': '2022-03-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-01-03', 'studyFirstPostDateStruct': {'date': '2012-08-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Successful Placement of a Functioning USGIV/IO', 'timeFrame': 'at time of vascular access'}, {'measure': 'Number of Successful Placements', 'timeFrame': 'at time of vascular access'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Intraosseous (IO) vascular access'], 'conditions': ['Difficult Peripheral IV Access']}, 'descriptionModule': {'briefSummary': 'By doing this study, the investigators hope to learn whether patients with difficult to obtain IV access who are treated with IO access are more satisfied with their care and have better outcomes. The investigators are specifically studying the time difference between groups and the difference in the number of attempts required to obtain vascular access and begin to treat with fluids and medications. The study will also measure patient satisfaction and procedural pain, the frequency of central line placement, the length of stay in the hospital and emergency department, and adverse events to intravascular access to determine whether IO access can improve these measures.\n\nThe investigators hypothesize that the use of a protocol utilizing an IO device for select patients with failed IV access will reduce the time requirements to obtain vascular access, reduce the number of attempts needed to obtain IV access, reduce the ED LOS, and have no negative impact on patient satisfaction compared to the current ED practices.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18 years of age or older\n2. Hemodynamically stable\n3. Speaks English\n4. Able to consent\n5. Has difficult IV access\n\nExclusion Criteria:\n\n1\\. Patients who are younger than 18 years of age, b) lack English fluency c) are unable to give informed consent d) require immediate central venous access e) have a history of osteomyelitis in the only target location of IO access f) have a fracture in the bone of the only target IO site g) have received an IO in the last 24 hours of the only target site h) are allergic to lidocaine i) pregnant or j) require a contrast CT scan as part of their ED care will be excluded.\n\nWhile pregnant patients may benefit from rescue access the use of lidocaine to anesthetize the medullary space has not been studied in this population.'}, 'identificationModule': {'nctId': 'NCT01676350', 'briefTitle': 'Intraosseous Access in the Emergency Department for Patients With Failed Attempts at Intravenous Access: A Randomized Trial Examining Resource Utilization and Patient Satisfaction', 'organization': {'class': 'OTHER', 'fullName': 'WellSpan Health'}, 'officialTitle': 'Intraosseous Access in the Emergency Department for Patients With Failed Attempts at Intravenous Access: A Randomized Trial Examining Resource Utilization and Patient Satisfaction', 'orgStudyIdInfo': {'id': '299341'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard of care', 'description': 'If you are assigned to this group, ultrasound-guided IV will be used to obtain vascular access.'}, {'type': 'EXPERIMENTAL', 'label': 'IO access using EZ-IO®', 'description': 'If you are assigned to this group, you will receive an IO line in the humeral head of the shoulder. IO lines are placed using an FDA-approved device called an EZ-IO®.', 'interventionNames': ['Procedure: IO access using EZ-IO®']}], 'interventions': [{'name': 'IO access using EZ-IO®', 'type': 'PROCEDURE', 'otherNames': ['EZ-IO®'], 'description': 'IO line placed using an FDA-approved device called an EZ-IO®.', 'armGroupLabels': ['IO access using EZ-IO®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hospital of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '17405', 'city': 'York', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'York Hospital', 'geoPoint': {'lat': 39.9626, 'lon': -76.72774}}], 'overallOfficials': [{'name': 'Erik Kochert, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'York Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'WellSpan Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Pennsylvania', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}