Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-01-31 @ 3:58 AM
Study NCT ID:
NCT02275520
Status:
COMPLETED
Last Update Posted:
2015-05-13
First Post:
2014-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraosseous Access
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 137}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-11', 'studyFirstSubmitDate': '2014-10-22', 'studyFirstSubmitQcDate': '2014-10-24', 'lastUpdatePostDateStruct': {'date': '2015-05-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time to IO needle insertion', 'timeFrame': '1 day', 'description': 'time from picking up a intraosseous access device, to successful IO needle insertion in the bone'}], 'secondaryOutcomes': [{'measure': 'time to IO needle stabilization', 'timeFrame': '1 day', 'description': 'time from picking up a intraosseus access device to correct fixation IO needle'}, {'measure': 'time to intraosseuss infusion', 'timeFrame': '1 day', 'description': 'begining with picking up a intraosseuss access device and ending with the IV line tubing was connected to the inseted IO needle'}, {'measure': 'Ease of use', 'timeFrame': '1 day', 'description': 'To access subjective opinion about the difficulty of the procedure, participants were asked to rate it on a visual analogue scale (VAS) with a score from 1 (extremely easy) to 10 (extremely difficult).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Intraosseus Access', 'Manikin', 'Resuscitation']}, 'descriptionModule': {'briefSummary': 'The investigators will compare the success rates and time to successful IO access during simulated adult resuscitation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Give voluntary consent to participate in the study\n* paramedic\n* more than 1 year experience in medicine\n\nExclusion Criteria:\n\n* Not meet the above criteria\n* Wrist or Low back diseases'}, 'identificationModule': {'nctId': 'NCT02275520', 'acronym': 'NIO', 'briefTitle': 'Intraosseous Access', 'organization': {'class': 'OTHER', 'fullName': 'International Institute of Rescue Research and Education'}, 'officialTitle': 'Comparison of NIO, BIG, EZ-IO, Jamshidi and Cook Intraosseous Devices in Adult Patients Under Resuscitation by Paramedics: a Randomized Crossover Manikin Trial.', 'orgStudyIdInfo': {'id': 'IO2014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'IO access', 'description': 'Performed intraosseus access device during simulated cardiopulmonary resuscitation', 'interventionNames': ['Device: NIO Adult device', 'Device: Bone Iniection Gun', 'Device: EZ-IO', 'Device: Jamshidi Intraosseous Needle', 'Device: Cook Intraosseous Needle']}], 'interventions': [{'name': 'NIO Adult device', 'type': 'DEVICE', 'otherNames': ['NIO'], 'description': 'IO access-1', 'armGroupLabels': ['IO access']}, {'name': 'Bone Iniection Gun', 'type': 'DEVICE', 'otherNames': ['BIG'], 'description': 'IO access-2', 'armGroupLabels': ['IO access']}, {'name': 'EZ-IO', 'type': 'DEVICE', 'description': 'IO access-3', 'armGroupLabels': ['IO access']}, {'name': 'Jamshidi Intraosseous Needle', 'type': 'DEVICE', 'otherNames': ['Jamshidi'], 'description': 'IO access-4', 'armGroupLabels': ['IO access']}, {'name': 'Cook Intraosseous Needle', 'type': 'DEVICE', 'otherNames': ['Cook'], 'description': 'IO access-5', 'armGroupLabels': ['IO access']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03-122', 'city': 'Warsaw', 'state': 'Masovia', 'country': 'Poland', 'facility': 'International Institute of Rescue Research and Education', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'overallOfficials': [{'name': 'Lukasz Szarpak', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institute of Cardiology, Warsaw, Poland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'International Institute of Rescue Research and Education', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lukasz Szarpak', 'investigatorFullName': 'Lukasz Szarpak', 'investigatorAffiliation': 'National Institute of Cardiology, Warsaw, Poland'}}}}