- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01401920
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
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.
The investigators evaluated the effect of passive leg elevation on the cross-sectional area of IJV in subjects undergoing open heart surgery for congenital anomaly.
Study Overview
Status
Detailed Description
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.
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. 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Seoul, Korea, Republic of, 135-710
- Samsung Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- infants or children under 5 yrs undergoing elective open heart surgery for congenital anomaly for study period
Exclusion Criteria:
- previous history of internal jugular vein cannulation
- concurrent pulmonary disease that can influence the hemodynamics of right heart
- increased intracranial pressure
- hemodynamic unstability
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
patients undergoing open heart surgery
small infant or children patients undergoing open heart surgery
|
bilateral passive leg elevation for 30 seconds
Trendelenburg position (15 degrees) for 30 seconds
Trendelenburg position + passive leg elevation
supine position without passive leg elevation or trendelenburg position
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cross-sectional area of internal jugular vein
Time Frame: one time measurement 10 min before jugular vein cannulation
|
Cross-sectional area of internal jugular vein measured on the ultrasonographic image with planimetry method
|
one time measurement 10 min before jugular vein cannulation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Transverse diameter of internal jugular vein
Time Frame: only one time measurements 10 min before internal jugular vein cannulation
|
Transverse diameter of internal jugular vein measured on the ultrasonographic image
|
only one time measurements 10 min before internal jugular vein cannulation
|
|
horizontal diameter of internal jugular vein
Time Frame: only one time measurements 10 min before jugular vein cannulation
|
horizontal diameter of internal jugular vein measured on the ultrasonographic image
|
only one time measurements 10 min before jugular vein cannulation
|
|
skin to internal jugular vein depth
Time Frame: one time measurement 10 min before jugular vein cannulation
|
skin to internal jugular vein depth measured on the ultrasonographic image
|
one time measurement 10 min before jugular vein cannulation
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Chung Su Kim, M.D.,Ph.D., Samsung Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2011-05-093
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