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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
  Purpose

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.


Condition Intervention
Infants or Children Undergoing Open Heart Surgery
 Other: leg elevation
Other: Trendelenburg position
Other: Trendelenburg position + passive leg elevation
Other: control group

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official 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

Resource links provided by NLM:

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 120
Study Start Date: July 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
patients undergoing open heart surgery
small infant or children patients 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

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.

  Eligibility

Ages Eligible for Study:   up to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01401920

Contacts
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

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
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    
Principal Investigator: Chung Su Kim, M.D.,Ph.D.            
Principal Investigator: Won Ho Kim, M.D.            
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Chung Su Kim, M.D.,Ph.D. Samsung Medical Center
  More Information

No publications provided

Responsible Party: Chung Su Kim, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01401920     History of Changes
Other Study ID Numbers: 2011-05-093
Study First Received: July 22, 2011
Last Updated: July 22, 2011
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
internal jugular vein cannulation
cross-sectional area
passive leg elevation
trendelenburg position
open heart surgery

ClinicalTrials.gov processed this record on May 16, 2013