Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2026-02-23 @ 8:09 PM
Study NCT ID:
NCT01401920
Status:
COMPLETED
Last Update Posted:
2013-12-25
First Post:
2011-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Influence of Passive Leg Elevation on the Cross-sectional Area of the Internal Jugular Vein in Infants or Young Children Undergoing Open Heart Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D018475', 'term': 'Head-Down Tilt'}, {'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D011187', 'term': 'Posture'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-24', 'studyFirstSubmitDate': '2011-07-22', 'studyFirstSubmitQcDate': '2011-07-22', 'lastUpdatePostDateStruct': {'date': '2013-12-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cross-sectional area of internal jugular vein', 'timeFrame': 'one time measurement 10 min before jugular vein cannulation', 'description': 'Cross-sectional area of internal jugular vein measured on the ultrasonographic image with planimetry method'}], 'secondaryOutcomes': [{'measure': 'Transverse diameter of internal jugular vein', 'timeFrame': 'only one time measurements 10 min before internal jugular vein cannulation', 'description': 'Transverse diameter of internal jugular vein measured on the ultrasonographic image'}, {'measure': 'horizontal diameter of internal jugular vein', 'timeFrame': 'only one time measurements 10 min before jugular vein cannulation', 'description': 'horizontal diameter of internal jugular vein measured on the ultrasonographic image'}, {'measure': 'skin to internal jugular vein depth', 'timeFrame': 'one time measurement 10 min before jugular vein cannulation', 'description': 'skin to internal jugular vein depth measured on the ultrasonographic image'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['internal jugular vein cannulation', 'cross-sectional area', 'passive leg elevation', 'trendelenburg position', 'open heart surgery'], 'conditions': ['Infants or Children Undergoing Open Heart Surgery']}, 'descriptionModule': {'briefSummary': 'The trendelenburg position is usually applied to increase the cross-sectional area of the IJV. However, trendelenburg position requires a tilt table to place the head in the down position. Trendelenburg position could also increase intracranial pressure. Passive leg elevation redistributes more blood from the lower extremity into the central veins and is proved to increase the cross-sectional area of IJV in adults. However, the effect of leg elevation on the cross-sectional area of IJV in small infants and children has not been evaluated.\n\nThe investigators evaluated the effect of passive leg elevation on the cross-sectional area of IJV in subjects undergoing open heart surgery for congenital anomaly.', 'detailedDescription': 'Internal jugular vein (IJV) cannulation is essential for open heart surgery of small infants and children for transfusion or inotropics infusion. The trendelenburg position is usually applied to increase the cross-sectional area of the IJV.\n\nHowever, trendelenburg position requires a tilt table to place the head in the down position. Trendelenburg position could also increase intracranial pressure. Passive leg elevation redistributes more blood from the lower extremity into the central veins and is proved to increase the cross-sectional area of IJV in adults. However, the effect of leg elevation on the cross-sectional area of IJV in small infants and children has not been evaluated. Furthermore, the children undergoing open heart surgery due to cardiac anomaly have an altered hemodynamics and often congested right heart. Therefore, the response of passive leg elevation may be different from that of normal heart physiology. Therefore, we evaluated the effect of passive leg elevation on the cross-sectional area of IJV in subjects undergoing open heart surgery for congenital anomaly.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'infants or children undergoing open heart surgery for congenital anomaly for study period', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* infants or children under 5 yrs undergoing elective open heart surgery for congenital anomaly for study period\n\nExclusion Criteria:\n\n* previous history of internal jugular vein cannulation\n* concurrent pulmonary disease that can influence the hemodynamics of right heart\n* increased intracranial pressure\n* hemodynamic unstability'}, 'identificationModule': {'nctId': 'NCT01401920', 'briefTitle': 'The Influence of Passive Leg Elevation on the Cross-sectional Area of the Internal Jugular Vein in Infants or Young Children Undergoing Open Heart Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'The Influence of Passive Leg Elevation on the Cross-sectional Area of the Internal Jugular Vein in Infants or Young Children Undergoing Open Heart Surgery', 'orgStudyIdInfo': {'id': '2011-05-093'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients undergoing open heart surgery', 'description': 'small infant or children patients undergoing open heart surgery', 'interventionNames': ['Other: leg elevation', 'Other: Trendelenburg position', 'Other: Trendelenburg position + passive leg elevation', 'Other: control group']}], 'interventions': [{'name': 'leg elevation', 'type': 'OTHER', 'description': 'bilateral passive leg elevation for 30 seconds', 'armGroupLabels': ['patients undergoing open heart surgery']}, {'name': 'Trendelenburg position', 'type': 'OTHER', 'description': 'Trendelenburg position (15 degrees) for 30 seconds', 'armGroupLabels': ['patients undergoing open heart surgery']}, {'name': 'Trendelenburg position + passive leg elevation', 'type': 'OTHER', 'description': 'Trendelenburg position + passive leg elevation', 'armGroupLabels': ['patients undergoing open heart surgery']}, {'name': 'control group', 'type': 'OTHER', 'description': 'supine position without passive leg elevation or trendelenburg position', 'armGroupLabels': ['patients undergoing open heart surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Chung Su Kim, M.D.,Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Chung Su Kim', 'investigatorAffiliation': 'Samsung Medical Center'}}}}