Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 12:36 AM
Study NCT ID:
NCT01543360
Status:
COMPLETED
Last Update Posted:
2025-11-19
First Post:
2012-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Axillary Versus Subclavian Vein Strategies for Central Venous Catheterization Under Continuous Ultrasound Guidance
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': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2013-05-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2012-02-20', 'studyFirstSubmitQcDate': '2012-03-02', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Central venous catheter established within first 2 puncture attempts', 'timeFrame': 'approximately 3 minutes', 'description': 'yes/no'}], 'secondaryOutcomes': [{'measure': 'Central venous catheter established upon first punction attempt', 'timeFrame': 'approximately 3 minutes', 'description': 'yes/no'}, {'measure': 'Establishment of a central venous catheter', 'timeFrame': 'approximately 3 minutes', 'description': 'yes/no'}, {'measure': 'The time necessary for the establishment of a central venous catheter', 'timeFrame': 'approximately 3 minutes', 'description': 'For non-failures (ie establishment of a central venous catheter within 4 puncture attempts), the number of minutes necessary for the establishment of a central venous catheter'}, {'measure': 'The time necessary for the establishment of a central venous catheter', 'timeFrame': 'approximately 3 minutes', 'description': 'all cases, in minutes'}, {'measure': 'presence/absence of complications', 'timeFrame': 'Day 1', 'description': 'arterial puncture (yes / no), pneumothorax (yes / no), hemothorax (yes / no), hematoma (yes / no), nerve injury (yes / no), aberrant course (yes / no)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['axillary vein', 'sub clavian vein', 'comparison of strategies'], 'conditions': ['Central Venous Catheterization']}, 'referencesModule': {'references': [{'pmid': '26787790', 'type': 'RESULT', 'citation': 'Buzancais G, Roger C, Bastide S, Jeannes P, Lefrant JY, Muller L. Comparison of two ultrasound guided approaches for axillary vein catheterization: a randomized controlled non-inferiority trial. Br J Anaesth. 2016 Feb;116(2):215-22. doi: 10.1093/bja/aev458.'}]}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to compare the rate of successful establishment of a central venous catheter in the first two attempts of ultrasound-guided puncture between two techniques: (1) a subclavian technique versus (2) an axillary technique.', 'detailedDescription': 'The secondary objectives of this study are to compare the following between the two techniques:\n\n* the success rate of the establishment of a central venous catheter\n* the success rate of establishment of a central venous catheter at the first attempt at venipuncture\n* for non-failures (eg, a catheter is placed in the first four trys), time to cannulation\n* the presence / absence of the following complications:\n* arterial puncture (yes / no)\n* pneumothorax (yes / no)\n* hemothorax (yes / no)\n* hematoma (yes / no)\n* nerve injury (yes / no)\n* aberrant course (yes / no)\n\nThe reasons catheter placement failures will also be described.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient must have given his/her informed and signed consent\n* The patient must be insured or beneficiary of a health insurance plan\n* The patient is available for 24 hours of follow-up\n* Patient requiring the establishment of a central venous catheter\n\nExclusion Criteria:\n\n* The patient is in an exclusion period determined by a previous study\n* The patient is under judicial protection, under tutorship or curatorship\n* The patient refuses to sign the consent\n* It is impossible to correctly inform the patient\n* The patient is pregnant, parturient, or breastfeeding\n* Patient has a body mass index \\< 15 or \\> 40\n* Congenital or acquired anatomical deformity (radiation therapy, trauma, surgery) of the axillary and/or subclavian regions\n* Bleeding disorder (platelets \\< 50,000, prothrombine \\< 50%, activated cephaline time \\> 2 times the control value)\n* Severe hypoxemia defined by a ratio PaO2 / FIO2 \\< 100\n* Infection of the puncture area\n* Known thrombosis of the subclavian or axillary veins\n* Scheduled length of hospitalization less than 24 hours\n* Agitated or non-cooperative patient\n* The patient has already been included in this study\n* subclavian and axillary veins are not simultaneously echogenic on one or both sides (left and right).'}, 'identificationModule': {'nctId': 'NCT01543360', 'briefTitle': 'Comparison of Axillary Versus Subclavian Vein Strategies for Central Venous Catheterization Under Continuous Ultrasound Guidance', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Comparison of Axillary Versus Subclavian Vein Strategies for Central Venous Catheterization Under Continuous Ultrasound Guidance: a Prospective, Randomized, Non-inferiority Study', 'orgStudyIdInfo': {'id': 'LOCAL/2011/JYL-GB-01'}, 'secondaryIdInfos': [{'id': '2011-A01353-38', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Axillary strategy', 'description': 'The first two attempts at central venous catheterization will be performed via the distal approach (axillary vein). The third and fourth attempts at central venous catheterization will be performed by the medial approach (subclavian vein).', 'interventionNames': ['Procedure: Axillary strategy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Subclavian strategy', 'description': 'The first two attempts at central venous catheterization will be performed by the medial approach (subclavian vein). The third and fourth attempts at central venous catheterization will be performed by the distal approach (axillary vein).', 'interventionNames': ['Procedure: Subclavian strategy']}], 'interventions': [{'name': 'Axillary strategy', 'type': 'PROCEDURE', 'description': 'The first two attempts at central venous catheterization will be performed via the distal approach (axillary vein). The third and fourth attempts at central venous catheterization will be performed by the medial approach (subclavian vein). The same puncture material/devices will be used in both arms of the study.', 'armGroupLabels': ['Axillary strategy']}, {'name': 'Subclavian strategy', 'type': 'PROCEDURE', 'description': 'The first two attempts at central venous catheterization will be performed by the medial approach (subclavian vein). The third and fourth attempts at central venous catheterization will be performed by the distal approach (axillary vein). The same puncture material/devices will be used in both arms of the study.', 'armGroupLabels': ['Subclavian strategy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30029', 'city': 'Nîmes', 'state': 'Gard', 'country': 'France', 'facility': 'CHU de Nîmes - Hôpital Universitaire Carémeau', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}], 'overallOfficials': [{'name': 'Jean Yves Lefrant, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Nîmes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}