Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2026-01-04 @ 6:38 AM
Study NCT ID:
NCT03162757
Status:
COMPLETED
Last Update Posted:
2025-11-21
First Post:
2017-05-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Ultrasound-guided Central Venous Catherterization Via the Lower Internal Jugular Vein or the Subclavian Vein
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 210}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-07-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2017-05-12', 'studyFirstSubmitQcDate': '2017-05-19', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful placement catheter from a maximum of two attempts', 'timeFrame': 'During procedure', 'description': 'Binary yes/no'}], 'secondaryOutcomes': [{'measure': 'Pneumothorax', 'timeFrame': '1 day', 'description': 'binary yes/no'}, {'measure': 'arterial puncture', 'timeFrame': 'within 1 hour', 'description': 'binary yes/no'}, {'measure': 'failure', 'timeFrame': 'within 1 hour', 'description': 'binary yes/no'}, {'measure': 'arrhythmia', 'timeFrame': 'within 1 hour', 'description': 'binary yes/no'}, {'measure': 'abberant placement of catheter', 'timeFrame': '1 day', 'description': 'binary yes/no'}, {'measure': 'catheter infection', 'timeFrame': 'at removal of catheter; on average 6.5 days', 'description': 'binary yes/no'}, {'measure': 'catheter colonization', 'timeFrame': 'at removal of catheter; on average 6.5 days', 'description': 'binary yes/no'}, {'measure': 'mediastinal hematoma', 'timeFrame': '1 day', 'description': 'binary yes/no'}, {'measure': 'thrombosis', 'timeFrame': 'until removal of catheter; on average 6.5 days', 'description': 'binary yes/no'}, {'measure': 'success at first attempt', 'timeFrame': 'within 1 hour', 'description': 'yes/no'}, {'measure': 'time between puncture until insertion of guide', 'timeFrame': 'within 1 hour', 'description': 'measure in seconds'}, {'measure': 'clinical variables associated with failure of the techniques', 'timeFrame': 'within 24 hours'}, {'measure': 'number of dressings', 'timeFrame': 'over length of hospitalization; maximum 40 days', 'description': 'per day'}, {'measure': 'nurse-rated satisfaction at each dressing replacement', 'timeFrame': 'over length of hospitalization; maximum 40 days', 'description': 'score 0-10'}, {'measure': 'haemothorax', 'timeFrame': '1 day', 'description': 'binary yes/no'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Central Venous Access']}, 'referencesModule': {'references': [{'pmid': '36385459', 'type': 'RESULT', 'citation': 'Fournil C, Boulet N, Bastide S, Louart B, Ambert A, Boutin C, Lefrant JY, Muller L, Roger C. High success rates of ultrasound-guided distal internal jugular vein and axillary vein approaches for central venous catheterization: A randomized controlled open-label pilot trial. J Clin Ultrasound. 2023 Jan;51(1):158-166. doi: 10.1002/jcu.23383. Epub 2022 Nov 17.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this pilot study is to establish the success rate of catheterization of the lower jugular vein and the subclavian vein under ultrasound guidance in real time. The purpose is to compare the two techniques and to determine the best design for a full study (superiority, non-inferiority). This is a 2-arm randomized control study. The randomization ensures the comparability of the groups and allows evaluation of the feasibility and potential bias for further comparative studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The patient has been, or will be, informed as soon as their state of health allows them to be entered into the study of its objectives, constraints and the patient's rights\n* The patient have given their free and informed consent and signed the consent form\n* The patient must be insured or a beneficiary of a health insurance plan\n* The patient is over 18 years old\n* The patient needs a venous catheter in the superior vena cava\n\nExclusion Criteria:\n\n* The patient is already participating in another interventional study that could influence the results of this study\n* The patient has participated in another interventional study within the previous 3 months that could influence the results of this study\n* The patient is in a period of exclusion determined by a previous study\n* The patient is under judicial protection or is an adult under guardianship\n* The patient refuses to sign the consent form\n* Non-echogenic patient\n* Moribund patient\n* The patient has a contra-indication to one or other of the approaches: infection of the insertion zone, known thrombosis, severely dyspneic\n* Patient has severe coagulation problems: PT\\<40%, platelets\\<50 000 and curable anticoagulation with antiXa \\> 0.5 or INR\\>3.\n* Patient has a congenital or acquired deformation at the entry site"}, 'identificationModule': {'nctId': 'NCT03162757', 'acronym': 'JI vs SC', 'briefTitle': 'Comparison of Ultrasound-guided Central Venous Catherterization Via the Lower Internal Jugular Vein or the Subclavian Vein', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Comparison of Ultrasound-guided Central Venous Catherterization Via the Lower Internal Jugular Vein or the Subclavian Vein', 'orgStudyIdInfo': {'id': 'Local/2016/CR-02'}, 'secondaryIdInfos': [{'id': '2016-A01400-51', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Subclavian vein access', 'interventionNames': ['Procedure: Central venous catheterization']}, {'type': 'EXPERIMENTAL', 'label': 'Internal jugular vein access', 'interventionNames': ['Procedure: Central venous catheterization']}], 'interventions': [{'name': 'Central venous catheterization', 'type': 'PROCEDURE', 'description': 'Central venous catheterization via either internal jugular vein or subclavian vein up to a maximum of two attempts.', 'armGroupLabels': ['Internal jugular vein access', 'Subclavian vein access']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHU Nimes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}], 'overallOfficials': [{'name': 'Claire Roger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Nimes'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}