Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2026-01-05 @ 2:36 AM
Study NCT ID:
NCT03082066
Status:
COMPLETED
Last Update Posted:
2021-03-02
First Post:
2017-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Soft Tissue and Bone Diameter in Children and Adults for Intraosseus Access
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2018-03-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-27', 'studyFirstSubmitDate': '2017-02-27', 'studyFirstSubmitQcDate': '2017-03-11', 'lastUpdatePostDateStruct': {'date': '2021-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Soft tissue diameter', 'timeFrame': 'Retrospective single time measurement on MRI or CT scan. Measurement will last approx. 10 minutes, an will happen only once', 'description': 'CT or MRI performed for underlying disease. Diameter of soft tissue at the site of recommended intraosseus bone access'}], 'secondaryOutcomes': [{'measure': 'Bone tissue diameter', 'timeFrame': 'Retrospective single time measurement on MRI or CT scan.Measurement will last approx. 10 minutes, an will happen only once', 'description': 'CT or MRI performed for underlying disease. Diameter of bone cortical and spongiosa at the site of recommended intraosseus bone access'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bone access', 'intraosseus needle', 'resuscitation', 'infusion', 'volume therapy', 'emergency'], 'conditions': ['Emergencies', 'Infusion Site Injury', 'Bone Infection']}, 'descriptionModule': {'briefSummary': 'Retrospective observational study: Soft tissue and bone diameters are assessed in MRI and CT scans of patients. Data is compared with recommendations of intraosseus needle producers to assess whether the information provided by the producers can be optimised. Study sites are head of humerus bone, distal femur, proximal and distal tibia in accordance with recommended intraosseus access sites.\n\nPrimary and secondary outcome parameters will be assessed at one time only, i.e. when the patient has received MRI or CT scan for the diagnostic work up of their primary disease. Data collection for a given patient in this study can be completed within one session, e.g. 5-10 minutes. No additional investigation is required for this retrospective study.', 'detailedDescription': 'Retrospective observational single centre study: Soft tissue and bone diameters are assessed in MRI and CT scans of patients. Data is compared with recommendations of intraosseus needle producers to assess whether the information provided by the producers can be optimised. Study sites are head of humerus bone, distal femur, proximal and distal tibia in accordance with recommended intraosseus access sites. Data is gathered from patients who undergo either MRI or CT scanning for any disease and where bone at the IO puncture site is accessible for measurements required for this study.\n\nPrimary and secondary outcome parameters will be assessed at one time only, i.e. when the patient has received MRI or CT scan for the diagnostic work up of their primary disease. Data collection for a given patient in this study can be completed within one session, e.g. 5-10 minutes. No additional investigation is required for this'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '0 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients 0-90 years of age with elective MRI or CT scan within a 24 months period at the university hospital Innsbruck, Austria. Patients in analgosedation, anaesthesia, and stand-by', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients 0-90 years of age with elective or emergency MRI or CT scan within a 24 months period at the university hospital Innsbruck, Austria. Patients in analgosedation, anaesthesia, and stand-by\n\nExclusion Criteria:\n\n* Pathologies at recommended intraosseus puncture - and investigation- site, i.e. proximal humerus, distal femur, proximal and distal tibia'}, 'identificationModule': {'nctId': 'NCT03082066', 'briefTitle': 'Soft Tissue and Bone Diameter in Children and Adults for Intraosseus Access', 'organization': {'class': 'OTHER', 'fullName': 'Medical University Innsbruck'}, 'officialTitle': 'Assessment of Soft Tissue and Bone Diameter for Intraosseus Access in Children and Adults', 'orgStudyIdInfo': {'id': 'AN2015-0093 348/4.17'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children', 'description': 'Younger 18 years: Newborns, infants, small child, school child, teens', 'interventionNames': ['Other: CT or MRI scan']}, {'label': 'Adults', 'description': 'Even or older 18 years', 'interventionNames': ['Other: CT or MRI scan']}], 'interventions': [{'name': 'CT or MRI scan', 'type': 'OTHER', 'description': 'CT or MRI performed for underlying disease. CT and MRI scans used to asses bone and soft tissue diameter', 'armGroupLabels': ['Adults', 'Children']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5020', 'city': 'Innsbruck', 'country': 'Austria', 'facility': 'University Hospital Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University Innsbruck', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ruth Kröss, MD EDAIC', 'class': 'UNKNOWN'}, {'name': 'Glodny Bernhard, MD PD Assoc. Prof.', 'class': 'UNKNOWN'}, {'name': 'Laura Trefzer, Cand med', 'class': 'UNKNOWN'}, {'name': 'Sabrina Neururer, DI BSc', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PD MBA EDAIC EDIC', 'investigatorFullName': 'Peter Paal, PD MD MBA EDAIC EDIC', 'investigatorAffiliation': 'Medical University Innsbruck'}}}}