Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2026-01-01 @ 4:19 PM
Study NCT ID:
NCT03207932
Status:
COMPLETED
Last Update Posted:
2020-11-10
First Post:
2017-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Guidance Versus Anatomical Landmarks for CVC Catheterisation:
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002405', 'term': 'Catheterization, Central Venous'}], 'ancestors': [{'id': 'D002404', 'term': 'Catheterization'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D057510', 'term': 'Endovascular Procedures'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2019-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-08', 'studyFirstSubmitDate': '2017-07-02', 'studyFirstSubmitQcDate': '2017-07-03', 'lastUpdatePostDateStruct': {'date': '2020-11-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The success rate for succlavic or femoral vein catetherisation using ultrasound versus landmark technique at the first attempt', 'timeFrame': 'during catheterization procedure', 'description': 'success rate'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Success Rate for Subclavian or Femoral Vein Catetherisation']}, 'descriptionModule': {'briefSummary': 'anatomical landmarks on the body surface were used to insert central vein catheter. However, ultrasound technique is emerging as a new technique for vein catheterisation. For subclavian and femoral vein catheterisation, up to now, there is a lack of evidence of the superiority of one technique over the other.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'intensive care patients', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients needing CVC\n\nExclusion Criteria:\n\n* refusal of consent'}, 'identificationModule': {'nctId': 'NCT03207932', 'briefTitle': 'Ultrasound Guidance Versus Anatomical Landmarks for CVC Catheterisation:', 'organization': {'class': 'OTHER', 'fullName': 'University of Pisa'}, 'officialTitle': 'Ultrasound Guidance Versus Anatomical Landmarks for Succlavic and Femoral Vein Catheterisation: an Observational Prospective Study', 'orgStudyIdInfo': {'id': 'UPisa - subclavian/femoral'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ultrasound', 'description': 'CVC insertion using ultrasound', 'interventionNames': ['Procedure: Central vein catheterisation']}, {'label': 'landmark technique', 'description': 'CVC insertion using landmark technique', 'interventionNames': ['Procedure: Central vein catheterisation']}], 'interventions': [{'name': 'Central vein catheterisation', 'type': 'PROCEDURE', 'description': 'ultrasound guided versus landmark central vein catheterisation', 'armGroupLabels': ['landmark technique', 'ultrasound']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Pisa', 'country': 'Italy', 'facility': 'Francesco Forfori', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pisa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Francesco Forfori', 'investigatorAffiliation': 'University of Pisa'}}}}