Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 9:57 PM
Study NCT ID:
NCT00904358
Status:
COMPLETED
Last Update Posted:
2017-06-06
First Post:
2009-05-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Estimation of Internal Jugular Vein Central Venous Pressure (CVP) by Ultrasound
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-04', 'studyFirstSubmitDate': '2009-05-15', 'studyFirstSubmitQcDate': '2009-05-18', 'lastUpdatePostDateStruct': {'date': '2017-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'internal jugular size', 'timeFrame': '1 day', 'description': 'Cross-sectional area of internal jugular vein measured by ultrasound'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['internal jugular vein', 'cross sectional area', 'ultrasound', 'central venous pressure'], 'conditions': ['Internal Jugular Size Measured by Ultrasound', 'Central Venous Pressure']}, 'descriptionModule': {'briefSummary': 'To study the validity and reliability of estimation of the central venous pressure by measurement of internal jugular vein size using 2-dimensional ultrasound.', 'detailedDescription': 'Objectives:\n\n1. To study the validity and reliability of estimation of the central venous pressure by measurement of internal jugular vein size using 2-dimensional ultrasound.\n2. To evaluate the correlation of internal jugular vein cross sectional area and central venous pressure.\n\nMethods:\n\n1. The study design is prospective observational study.\n2. We will include all patients scheduled for cardiac surgery in Siriraj Hospital and record both internal jugular size using 2-dimensional ultrasound just before central venous catheter insertion. The central venous pressure will be recorded and the ultrasound picture will be measured.\n3. The data will be analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients scheduled for cardiac surgery in Siriraj Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients scheduled for cardiac surgery\n* need central venous catheterization intraoperatively\n* elective surgery\n* age \\> 18\n\nExclusion Criteria:\n\n* neck pathology\n* history of internal jugular or SVC thrombosis\n* limited neck mobility\n* severe valvular lesion\n* decompensated heart failure'}, 'identificationModule': {'nctId': 'NCT00904358', 'briefTitle': 'Estimation of Internal Jugular Vein Central Venous Pressure (CVP) by Ultrasound', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Validity and Reliability of Non-invasive Estimation of Central Venous Pressure by Measurement of Internal Jugular Size Using 2-dimensional Ultrasound', 'orgStudyIdInfo': {'id': 'Si183/2009'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'cross sectional area', 'description': 'internal jugular cross sectional area measured by ultrasound', 'interventionNames': ['Diagnostic Test: cross sectional area']}], 'interventions': [{'name': 'cross sectional area', 'type': 'DIAGNOSTIC_TEST', 'armGroupLabels': ['cross sectional area']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Faculty of Medicine, Siriraj Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '10700', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Kasana Raksamani', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Kasana Raksamani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mahidol University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}