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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Samsung Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Jong Hwan Lee, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01575184
First received: April 10, 2012
Last updated: April 12, 2012
Last verified: April 2012
  Purpose

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 Intervention
Internal Jugular Vein Cannulation
Common Carotid Artery
Infants
Other: caudo-ipsilateral traction of shoulder
Other: The ultrasonographic measurements without shoulder traction

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Carotid artery (CA) overlap (%) [ Time Frame: 10 seconds after head positioning ] [ Designated as safety issue: No ]
    CA overlap = (overlap distance between CA and internal jugular vein)/CA diameter) × 100 measured by ultrasound image


Secondary Outcome Measures:
  • IJV (internal jugular vein) safety portion (%) [ Time Frame: 10 seconds after head positioning ] [ Designated as safety issue: No ]
    IJV safety portion = (1-ovelap distance/IJV diameter) × 100 measured by ultrasound image

  • overlap distance (mm) [ Time Frame: 10 seconds after head position ] [ Designated as safety issue: No ]
    overlap distance (mm) of carotid artery and internal jugular vein measured by ultrasound image

  • jugular to carotid distance (mm) [ Time Frame: 10 seconds after head position ] [ Designated as safety issue: No ]
    the distance (mm) between lateral border of carotid artery and center of internal jugula vein measured by ultrasound image

  • CA diameter (mm) [ Time Frame: 10 seconds after head positioning ] [ Designated as safety issue: No ]
    carotid artery diameter (mm) measured by ultrasound image

  • IJV diameter (mm) [ Time Frame: 10 seconds after head positioning ] [ Designated as safety issue: No ]
    internal jugualr vein diameter (mm) measured by ultrasound image


Estimated Enrollment: 25
Study Start Date: August 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   1 Month to 12 Months
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01575184

Contacts
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
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
Principal Investigator: Jong Hwan Lee, MD, PhD Samsung Medical Center
Principal Investigator: Won Ho Kim, MD Samsung Medical Center
  More Information

No publications provided

Responsible Party: Jong Hwan Lee, Assistant Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01575184     History of Changes
Other Study ID Numbers: SMC 2011-04-004-001
Study First Received: April 10, 2012
Last Updated: April 12, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
internal jugular vein cannulation
common carotid artery
infants

ClinicalTrials.gov processed this record on April 15, 2014