NCT01401920

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 25, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

December 25, 2013

Status Verified

December 1, 2013

Enrollment Period

5 months

First QC Date

July 22, 2011

Last Update Submit

December 24, 2013

Conditions

Infants or Children Undergoing Open Heart Surgery

Keywords

internal jugular vein cannulationcross-sectional areapassive leg elevationtrendelenburg positionopen heart surgery

Outcome Measures

Primary Outcomes (1)

  • Cross-sectional area of internal jugular vein

    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 Outcomes (3)

  • Transverse diameter of internal jugular vein

    only one time measurements 10 min before internal jugular vein cannulation

  • horizontal diameter of internal jugular vein

    only one time measurements 10 min before jugular vein cannulation

  • skin to internal jugular vein depth

    one time measurement 10 min before jugular vein cannulation

Study Arms (1)

patients undergoing open heart surgery

small infant or children patients undergoing open heart surgery

Other: leg elevationOther: Trendelenburg positionOther: Trendelenburg position + passive leg elevationOther: control group

Interventions

leg elevationOTHER

bilateral passive leg elevation for 30 seconds

patients undergoing open heart surgery
Trendelenburg positionOTHER

Trendelenburg position (15 degrees) for 30 seconds

patients undergoing open heart surgery
Trendelenburg position + passive leg elevationOTHER

Trendelenburg position + passive leg elevation

patients undergoing open heart surgery
control groupOTHER

supine position without passive leg elevation or trendelenburg position

patients undergoing open heart surgery

Eligibility Criteria

AgeUp to 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • infants or children under 5 yrs undergoing elective open heart surgery for congenital anomaly for study period

You may not qualify if:

  • previous history of internal jugular vein cannulation
  • concurrent pulmonary disease that can influence the hemodynamics of right heart
  • increased intracranial pressure
  • hemodynamic unstability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Interventions

Head-Down TiltControl Groups

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Chung Su Kim, M.D.,Ph.D.

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 22, 2011

First Posted

July 25, 2011

Study Start

July 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

December 25, 2013

Record last verified: 2013-12

Locations

KR(1)