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Effect of Shoulder Traction on Size and Relative Position of Internal Jugular Vein to Carotid Artery

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ClinicalTrials.gov Identifier: NCT01575184
Recruitment Status : Unknown
Verified April 2012 by Jong Hwan Lee, Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : April 11, 2012
Last Update Posted : April 13, 2012
Sponsor:
Information provided by (Responsible Party):
Jong Hwan Lee, Samsung Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Internal Jugular Vein Cannulation Common Carotid Artery Infants Other: caudo-ipsilateral traction of shoulder Other: The ultrasonographic measurements without shoulder traction Not Applicable

Detailed Description:

Central venous catheterization is frequently performed in pediatric patients undergoing major surgery for fluid management and vasoactive drug therapy. Compared to subclavian vein, internal jugular vein (IJV) is generally preferred for catheterization because of the low incidence of serious complications, such as pneumothorax and hemothorax. However, especially in infants, IJV catheterization is still technically difficult because of the small size of the vein and anatomical variation.

In previous studies, ultrasound guidance and keeping in neutral head position have been recommended to increase the success rate and to decrease the overlap between carotid artery (CA) and IJV, respectively. However, devices for ultrasonography are not always available. Moreover, IJV catheterization without head rotation could be extremely difficult in infants because of relative the larger skull and the smaller neck than those of adults. Therefore, a simple method to relieve the overlap between CA and IJV would be needed.

During head rotation to the contralateral side, the cephalic part of IJV is moved to the same direction. Accordingly, the investigators thought that the counter traction of the caudal part of IJV using the caudo-lateral traction of the ipsilateral arm might relieve the overlap caused from head rotation. Therefore, the investigators evaluated the effect of the caudo-lateral traction of the ipsilateral arm on the overlap between common CA and IJV in infants.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Official Title: Effect of Shoulder Position and Head Rotation on Size and Relative Position of Internal Jugular Vein to Carotid Artery in Infants and Children
Study Start Date : August 2011
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : June 2012
Arms and Interventions
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Arm Intervention/treatment
Experimental: Shoulder traction
The ultrasonographic measurements with shoulder traction
 Other: caudo-ipsilateral traction of shoulder
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.
Active Comparator: No traction
The ultrasonographic measurements without shoulder traction
 Other: The ultrasonographic measurements without shoulder traction
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.


Outcome Measures
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Primary Outcome Measures :
  1. Carotid artery (CA) overlap (%) [ Time Frame: 10 seconds after head positioning ]
    CA overlap = (overlap distance between CA and internal jugular vein)/CA diameter) × 100 measured by ultrasound image


Secondary Outcome Measures :
  1. IJV (internal jugular vein) safety portion (%) [ Time Frame: 10 seconds after head positioning ]
    IJV safety portion = (1-ovelap distance/IJV diameter) × 100 measured by ultrasound image

  2. overlap distance (mm) [ Time Frame: 10 seconds after head position ]
    overlap distance (mm) of carotid artery and internal jugular vein measured by ultrasound image

  3. jugular to carotid distance (mm) [ Time Frame: 10 seconds after head position ]
    the distance (mm) between lateral border of carotid artery and center of internal jugula vein measured by ultrasound image

  4. CA diameter (mm) [ Time Frame: 10 seconds after head positioning ]
    carotid artery diameter (mm) measured by ultrasound image

  5. IJV diameter (mm) [ Time Frame: 10 seconds after head positioning ]
    internal jugualr vein diameter (mm) measured by ultrasound image


Eligibility Criteria
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Ages Eligible for Study:   1 Month to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • infants undergoing elective surgery

Exclusion Criteria:

  • subjects with congenital heart disease or mass in head and neck
  • Subjects with anatomical malformation of great vessels
  • previous central venous access via IJV
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01575184


Contacts
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Contact: Jong Hwan Lee, MD, PhD 82-2-3410-1928 jonghwan75.lee@samsung.com
Contact: Ae Ryoung Lee, MD 82-2-3410-1929 nanrong.lee@samsung.com

Locations
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Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Jong Hwan Lee, MD, PhD    82-2-3410-1928    jonghwan75.lee@samsung.com   
Contact: Won Ho Kim, MD    82-2-3410-2470    bullet57@naver.com   
Sub-Investigator: Jong Hwan Lee, MD, PhD         
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Principal Investigator: Jong Hwan Lee, MD, PhD Samsung Medical Center
Principal Investigator: Won Ho Kim, MD Samsung Medical Center
More Information
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Responsible Party: Jong Hwan Lee, Assistant Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01575184    
Other Study ID Numbers: SMC 2011-04-004-001
First Posted: April 11, 2012    Key Record Dates
Last Update Posted: April 13, 2012
Last Verified: April 2012
Keywords provided by Jong Hwan Lee, Samsung Medical Center:
internal jugular vein cannulation
common carotid artery
infants