Effect of Shoulder Traction on Size and Relative Position of Internal Jugular Vein to Carotid Artery
Effect of Shoulder Position and Head Rotation on Size and Relative Position of Internal Jugular Vein to Carotid Artery in Infants and Children
1 other identifier
interventional
25
1 country
1
Brief Summary
Internal jugular vein (IJV) catheterization is frequently performed in infants undergoing major surgery. Although it has been suggested that head rotation increases the degree of overlapping between IJV and carotid artery (CA), IJV catheterization without head rotation is extremely difficult in infants. The aim of the present study is to evaluate whether the caudo-lateral traction of the ipsilateral arm can decrease the degree of overlapping between IJV and CA in infants during head rotation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 10, 2012
CompletedFirst Posted
Study publicly available on registry
April 11, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedApril 13, 2012
April 1, 2012
10 months
April 10, 2012
April 12, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Carotid artery (CA) overlap (%)
CA overlap = (overlap distance between CA and internal jugular vein)/CA diameter) × 100 measured by ultrasound image
10 seconds after head positioning
Secondary Outcomes (5)
IJV (internal jugular vein) safety portion (%)
10 seconds after head positioning
overlap distance (mm)
10 seconds after head position
jugular to carotid distance (mm)
10 seconds after head position
CA diameter (mm)
10 seconds after head positioning
IJV diameter (mm)
10 seconds after head positioning
Study Arms (2)
Shoulder traction
EXPERIMENTALThe ultrasonographic measurements with shoulder traction
No traction
ACTIVE COMPARATORThe ultrasonographic measurements without shoulder traction
Interventions
After the head rotation (0, 40, 80 degrees) to the contralateral side from the ultrasound measuring site, the slight caudo-ipsilateral traction of shoulder will be applied without changing the degree of the head rotation.
After the head rotation (0, 40, 80 degrees) to the contralateral side from the ultrasound measuring site, the no traction of shoulder will be applied.
Eligibility Criteria
You may qualify if:
- infants undergoing elective surgery
You may not qualify if:
- subjects with congenital heart disease or mass in head and neck
- Subjects with anatomical malformation of great vessels
- previous central venous access via IJV
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, 135-710, South Korea
Study Officials
- PRINCIPAL INVESTIGATOR
Jong Hwan Lee, MD, PhD
Samsung Medical Center
- PRINCIPAL INVESTIGATOR
Won Ho Kim, MD
Samsung Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
April 10, 2012
First Posted
April 11, 2012
Study Start
August 1, 2011
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
April 13, 2012
Record last verified: 2012-04