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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

This study is currently recruiting participants.
Verified July 2011 by Samsung Medical Center
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01401920
First received: July 22, 2011
Last updated: NA
Last verified: July 2011
History: No changes posted

July 22, 2011
July 22, 2011
July 2011
December 2011   (final data collection date for primary outcome measure)
Cross-sectional area of internal jugular vein [ Time Frame: one time measurement 10 min before jugular vein cannulation ] [ Designated as safety issue: No ]
Cross-sectional area of internal jugular vein measured on the ultrasonographic image with planimetry method
Same as current
No Changes Posted
  • Transverse diameter of internal jugular vein [ Time Frame: only one time measurements 10 min before internal jugular vein cannulation ] [ Designated as safety issue: No ]
    Transverse diameter of internal jugular vein measured on the ultrasonographic image
  • horizontal diameter of internal jugular vein [ Time Frame: only one time measurements 10 min before jugular vein cannulation ] [ Designated as safety issue: No ]
    horizontal diameter of internal jugular vein measured on the ultrasonographic image
  • skin to internal jugular vein depth [ Time Frame: one time measurement 10 min before jugular vein cannulation ] [ Designated as safety issue: No ]
    skin to internal jugular vein depth measured on the ultrasonographic image
Same as current
Not Provided
Not Provided
 
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 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.

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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

infants or children undergoing open heart surgery for congenital anomaly for study period
Infants or Children Undergoing Open Heart Surgery
  • Other: leg elevation
    bilateral passive leg elevation for 30 seconds
  • Other: Trendelenburg position
    Trendelenburg position (15 degrees) for 30 seconds
  • Other: Trendelenburg position + passive leg elevation
    Trendelenburg position + passive leg elevation
  • Other: control group
    supine position without passive leg elevation or trendelenburg position
patients undergoing open heart surgery
small infant or children patients undergoing open heart surgery
Interventions:
  • Other: leg elevation
  • Other: Trendelenburg position
  • Other: Trendelenburg position + passive leg elevation
  • Other: control group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
up to 5 Years
No
Contact: Chung Su Kim, M.D.,Ph.D. 82-2-3410-0365 chungsu.kim@samsung.com
Contact: Won Ho Kim, M.D. 82-2-3410-1994 bullet57@naver.com
Korea, Republic of
 
NCT01401920
2011-05-093
No
Chung Su Kim, Samsung Medical Center
Samsung Medical Center
Not Provided
Principal Investigator: Chung Su Kim, M.D.,Ph.D. Samsung Medical Center
Samsung Medical Center
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP