Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2026-01-08 @ 12:48 AM
Study NCT ID:
NCT01368692
Status:
COMPLETED
Last Update Posted:
2013-01-15
First Post:
2011-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Shoulder Retraction on Success Rate of Subclavian Vein Catheterization
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': 362}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-14', 'studyFirstSubmitDate': '2011-05-22', 'studyFirstSubmitQcDate': '2011-06-06', 'lastUpdatePostDateStruct': {'date': '2013-01-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'catheterization success rate', 'timeFrame': 'immediately after catheterization (an expected average of 1 hour)', 'description': 'Subclavian vein catheterization will be performed after the induction of anesthesia and before the start of surgery.'}], 'secondaryOutcomes': [{'measure': 'location of catheter tip', 'timeFrame': 'an expected average of one day after surgery', 'description': 'Postoperative chest X-ray will be taken to check for the location of catheter tip immediately after surgery.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['subclavian vein catheterization success rate'], 'conditions': ['Subclavian Vein Catheterization']}, 'referencesModule': {'references': [{'pmid': '23479675', 'type': 'DERIVED', 'citation': 'Kim HJ, Jung SH, Min J, Hong DM, Jeon Y, Bahk JH. Comparison of the neutral and retracted shoulder positions for infraclavicular subclavian venous catheterization: a randomized, non-inferiority trial. Br J Anaesth. 2013 Aug;111(2):191-6. doi: 10.1093/bja/aet026. Epub 2013 Mar 10.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the shoulder retraction by placing a saline bag between the scapula influences a success rate of subclavian vein catheterization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '82 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients undergoing neurosurgery or thoracic surgery that requires the placement of subclavian venous catheterization\n\nExclusion Criteria:\n\n* infection over the puncture site\n* history of prior clavicular fracture\n* anatomical anomaly of subclavian vein'}, 'identificationModule': {'nctId': 'NCT01368692', 'briefTitle': 'Effect of Shoulder Retraction on Success Rate of Subclavian Vein Catheterization', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'orgStudyIdInfo': {'id': 'H-1103-124-357'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'neutral shoulder', 'description': 'neutral shoulder position during subclavian vein catheterization', 'interventionNames': ['Procedure: position of neutral shoulder']}, {'type': 'EXPERIMENTAL', 'label': 'shoulder retraction', 'description': 'position of shoulder retraction during subclavian vein catheterization', 'interventionNames': ['Procedure: position of shoulder retraction']}], 'interventions': [{'name': 'position of shoulder retraction', 'type': 'PROCEDURE', 'description': 'position of shoulder retraction by placing a saline bag between the scapula', 'armGroupLabels': ['shoulder retraction']}, {'name': 'position of neutral shoulder', 'type': 'PROCEDURE', 'description': 'neutral shoulder position during subclavian vein catheterization', 'armGroupLabels': ['neutral shoulder']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jae-Hyon Bahk, MD, PhD', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}