Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2026-02-27 @ 10:37 AM
Study NCT ID:
NCT02941094
Status:
UNKNOWN
Last Update Posted:
2016-11-22
First Post:
2016-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Insertion Angle and Needle Visualization During Ultrasound Guided Internal Jugular Vein Cannulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-11-21', 'studyFirstSubmitDate': '2016-07-19', 'studyFirstSubmitQcDate': '2016-10-20', 'lastUpdatePostDateStruct': {'date': '2016-11-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'success rate', 'timeFrame': '24 hours starting from central line insertion'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Internal Jugular Vein Cannulation']}, 'descriptionModule': {'briefSummary': 'Ultrasound guidance has been established as an effective and safe method during insertion of internal jugular vein catheter.. Needle visualization during advancement toward the vein has a great impact on both safety and success of the procedure. Clinicians have adopted variable techniques to increase needle visualization including changing needle- probe relation (in-plane vs. out-of-plane), or using specific ultrasound needles The angle between the inserting needle and the probe lying on patient skin affects both the distance to the vein and the length of the needle part travelling through the us beam'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all patients requiring central line insertion\n\nExclusion Criteria:\n\n* refusal\n* coagulopathy\n* neck surgeries'}, 'identificationModule': {'nctId': 'NCT02941094', 'acronym': 'US_angle', 'briefTitle': 'Insertion Angle and Needle Visualization During Ultrasound Guided Internal Jugular Vein Cannulation', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'orgStudyIdInfo': {'id': 'refa-US-angle'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'angle 30 group', 'description': 'During central line insertion, After choosing the proper position, the skin was infiltrated with %1 lidocaine. The vein will be localized using linear ultrasound probe (PLT-805AT, 8 MHz, Toshiba Tokyo, Japan) attached to ultrasound machine (Xario, Toshiba Tokyo Japan). The needle will be advanced guided by the ultrasound probe with needle skin angle 30-40 degree.', 'interventionNames': ['Device: needle PLT-805AT', 'Device: Ultrasound']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'angle 50 group', 'description': 'During central line insertion,After choosing the proper position, the skin was infiltrated with %1 lidocaine. The vein will be localized using linear ultrasound probe (PLT-805AT, 8 MHz, Toshiba Tokyo, Japan) attached to ultrasound machine (Xario, Toshiba Tokyo Japan). The needle will be advanced guided by the ultrasound probe with needle skin angle 50-60 degree', 'interventionNames': ['Device: needle PLT-805AT', 'Device: Ultrasound']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'angle 70 group', 'description': 'During central line insertion,After choosing the proper position, the skin was infiltrated with %1 lidocaine. The vein will be localized using linear ultrasound probe (PLT-805AT, 8 MHz, Toshiba Tokyo, Japan) attached to ultrasound machine (Xario, Toshiba Tokyo Japan). The needle will be advanced guided by the ultrasound probe with needle skin angle 60-80 degree', 'interventionNames': ['Device: needle PLT-805AT', 'Device: Ultrasound']}], 'interventions': [{'name': 'needle PLT-805AT', 'type': 'DEVICE', 'otherNames': ['PLT-805AT, 8 MHz, Toshiba Tokyo, Japan'], 'description': 'comparing success rate and complications using different needle to US probe angles.', 'armGroupLabels': ['angle 30 group', 'angle 50 group', 'angle 70 group']}, {'name': 'Ultrasound', 'type': 'DEVICE', 'description': 'Xario, Toshiba Tokyo Japan', 'armGroupLabels': ['angle 30 group', 'angle 50 group', 'angle 70 group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Al Mansurah', 'state': 'Dkahleya', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Alreafey Kandeel, MD', 'role': 'CONTACT', 'email': 'refa3ey2@yahoo.com', 'phone': '00201008158591'}], 'facility': 'Mansoura university', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'AlRefaey Kandeel', 'investigatorAffiliation': 'Mansoura University'}}}}