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

December 24, 2013 updated by: Chung Su Kim, Samsung Medical Center

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

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

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

infants or children undergoing open heart surgery for congenital anomaly for study period

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Chung Su Kim, M.D.,Ph.D., Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

July 22, 2011

First Submitted That Met QC Criteria

July 22, 2011

First Posted (Estimate)

July 25, 2011

Study Record Updates

Last Update Posted (Estimate)

December 25, 2013

Last Update Submitted That Met QC Criteria

December 24, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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