Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2026-02-25 @ 9:44 PM
Study NCT ID:
NCT01888094
Status:
COMPLETED
Last Update Posted:
2016-06-27
First Post:
2013-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SUBclavian Central Venous Catheters Guidance and Examination by UltraSound
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012149', 'term': 'Restraint, Physical'}], 'ancestors': [{'id': 'D032763', 'term': 'Behavior Control'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007103', 'term': 'Immobilization'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-24', 'studyFirstSubmitDate': '2013-06-25', 'studyFirstSubmitQcDate': '2013-06-26', 'lastUpdatePostDateStruct': {'date': '2016-06-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'procedure time between the beginning of procedure ( TO) and when the catheter is controlled ( T4) between strategy catheter cannulation \'standard\' and a strategy called "ultrasound all', 'timeFrame': 'at day 1'}], 'secondaryOutcomes': [{'measure': 'procedure time Tn-Tn (n 0-5) between the two strategies.', 'timeFrame': 'at day 1'}, {'measure': 'incidence of occurrence of complications: pneumothorax, hemothorax, bad positioning (outside of the superior vena cava or the right atrium) between the two strategies', 'timeFrame': 'at day 1'}, {'measure': 'failure of technology between the two strategies.', 'timeFrame': 'at day 1'}, {'measure': 'occurrence of central venous catheter infection.', 'timeFrame': 'at day 1'}]}, 'conditionsModule': {'keywords': ['Central venous catheter', 'Complications', 'Ultrasound', 'Subclavian vein cannulation', 'Critical care', 'Echocardiography', 'Chest radiographyiography'], 'conditions': ['Requiring Subclavian Vein Cannulation', 'Adult Patients', 'Patient Covered by French Health Care System']}, 'referencesModule': {'references': [{'pmid': '24885789', 'type': 'DERIVED', 'citation': 'Perbet S, Pereira B, Grimaldi F, Duale C, Bazin JE, Constantin JM. Guidance and examination by ultrasound versus landmark and radiographic method for placement of subclavian central venous catheters: study protocol for a randomized controlled trial. Trials. 2014 May 20;15:175. doi: 10.1186/1745-6215-15-175.'}]}, 'descriptionModule': {'briefSummary': 'Prospective, randomized controlled clinical unicentric study, in ICU, Cannulation of the subclavian venous and examination guided with ultrasound', 'detailedDescription': 'One groupe : Ultrasound guided for cannulation and examination of absence ofcomplications One groupe : landmark method and examination with chest radiography'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults patients\n* requiring subclavian vein cannulation\n* patient covered by french health care system\n\nExclusion Criteria:\n\n* patient refusal\n* requiring vein cannulation femoral or jugular\n* we see nothing with echocardiography\n* children and not adult patients'}, 'identificationModule': {'nctId': 'NCT01888094', 'acronym': 'SUBGEUS', 'briefTitle': 'SUBclavian Central Venous Catheters Guidance and Examination by UltraSound', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'SUBclavian Central Venous Catheters Guidance and Examination by UltraSound : a Randomized Controlled Study Versus Landmark Method', 'orgStudyIdInfo': {'id': 'CHU-0159'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ultrasound guided for cannulation and examination', 'description': 'Prospective, randomized controlled clinical unicentric study, in ICU, Cannulation of the subclavian venous and examination guided with ultrasound', 'interventionNames': ['Other: Ultrasound-guided cannulation and examination']}, {'type': 'OTHER', 'label': 'landmark method and examination with chest radiography', 'description': 'Prospective, randomized controlled clinical unicentric study, in ICU, Cannulation of the subclavian venous and examination guided with ultrasound', 'interventionNames': ['Other: Ultrasound-guided cannulation and examination']}], 'interventions': [{'name': 'Ultrasound-guided cannulation and examination', 'type': 'OTHER', 'armGroupLabels': ['landmark method and examination with chest radiography', 'ultrasound guided for cannulation and examination']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'overallOfficials': [{'name': 'Sébastien PERBET', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Clermont-Ferrand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}