Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2026-01-05 @ 5:28 PM
Study NCT ID:
NCT03296735
Status:
UNKNOWN
Last Update Posted:
2017-10-11
First Post:
2017-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Difference in Subclavian Vein Catheterization Between Supine and Lateral Tilt Position - Stage I
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': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 17}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-10-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2019-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-10-09', 'studyFirstSubmitDate': '2017-09-25', 'studyFirstSubmitQcDate': '2017-09-25', 'lastUpdatePostDateStruct': {'date': '2017-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The cross-sectional area of right subclavian vein', 'timeFrame': '1 minutes after position change', 'description': 'The cross-sectional area of right subclavian vein'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Catheterization', 'Posture']}, 'referencesModule': {'references': [{'pmid': '32891115', 'type': 'DERIVED', 'citation': 'Yoon HK, Lee HC, Kang P, Lee JM, Park HP, Cho YJ. Effects of ipsilateral tilt position on the cross-sectional area of the subclavian vein and the clinical performance of subclavian vein catheterization: a prospective randomized trial. BMC Anesthesiol. 2020 Sep 5;20(1):226. doi: 10.1186/s12871-020-01144-1.'}, {'pmid': '29793550', 'type': 'DERIVED', 'citation': 'Jung DE, Lee HC, Yoon HK, Park HP. The effects of ipsilateral tilt position on right subclavian venous catheterization: study protocol for a prospective randomized trial. Trials. 2018 May 24;19(1):292. doi: 10.1186/s13063-018-2666-8.'}]}, 'descriptionModule': {'briefSummary': 'Central venous catheterization is widely used for various purposes during surgery. For central venous catheterization, subclavian vein is selected because of the relatively low risk of infection, long-term patency and low patient discomfort. The cross - sectional area of the subclavian vein is an important factor to increase success rate. Several studies have reported that the Trendelenburg position increases the cross-sectional area of the subclavian vein, and the lateral tilt position can change the cross-sectional area of the subclavian vein. However, the impact of lateral tilt position to the cross-sectional area of the subclavian vein is not clear. The ipsilateral position can increase the cross-sectional area of the subclavian vein, and the contralateral position can decrease the cross-sectional area by gravity.\n\nIn the first stage of this study, we compare the cross-sectional area of subclavian vein using ultrasonography in supine, ipsilateral, and contralateral tilt position.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- the patients who receive elective neurosurgical surgery and require central venous catheter\n\nExclusion Criteria:\n\n* the patients who have puncture site infection\n* the patients who have chemoport, pacemaker in right subclavian vein\n* the patients who had received right mastectomy or right pneumonectomy\n* other contraindications for subclavian venous catheterization (eg. mass, hematoma, vegetation, and anticoagulation)'}, 'identificationModule': {'nctId': 'NCT03296735', 'briefTitle': 'A Difference in Subclavian Vein Catheterization Between Supine and Lateral Tilt Position - Stage I', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'A Difference in the Cross-section Area of Subclavian Vein Between Supine and Lateral Tilt Position: Its Clinical Impact on Subclavian Venous Catheterization - Stage II', 'orgStudyIdInfo': {'id': '2017-110-871-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ipsilateral tilt', 'description': 'Measuring the cross-sectional area of right subclavian vein in the 20 degree left tilting posture.', 'interventionNames': ['Procedure: Ipsilateral tilt']}, {'type': 'NO_INTERVENTION', 'label': 'Supine', 'description': 'Measuring the cross-sectional area of right subclavian vein in supine position.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Contralateral tilt', 'description': 'Measuring the cross-sectional area of right subclavian vein in the 20 degree left tilting posture.', 'interventionNames': ['Procedure: Contralateral tilt']}], 'interventions': [{'name': 'Ipsilateral tilt', 'type': 'PROCEDURE', 'description': 'The operation table will be tilted 20 degrees right laterally.', 'armGroupLabels': ['Ipsilateral tilt']}, {'name': 'Contralateral tilt', 'type': 'PROCEDURE', 'description': 'The operation table will be tilted 20 degrees left laterally.', 'armGroupLabels': ['Contralateral tilt']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Hyung-Chul Lee, MD', 'role': 'CONTACT', 'email': 'lucid80@gmail.com', 'phone': '+82-10-2456-6336'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hee-Pyoung Park', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}