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Completed

NCT Number: 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.

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Key information

Conditions

Infants or Children Undergoing Open Heart Surgery

Age range

Up to 5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

leg elevation

Other

bilateral passive leg elevation for 30 seconds

Trendelenburg position

Other

Trendelenburg position (15 degrees) for 30 seconds

Trendelenburg position + passive leg elevation

Other

Trendelenburg position + passive leg elevation

Control Group

Other

supine position without passive leg elevation or trendelenburg position

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jul 25, 2011
Registry last updated
Dec 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.