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

Sponsor
Samsung Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT01575184
Collaborator
(none)
25
1
2
10
2.5

Study Details

Study Description

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
  • Other: caudo-ipsilateral traction of shoulder
  • Other: The ultrasonographic measurements without shoulder traction
N/A

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

Study Type:
Interventional
Anticipated 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 :
Aug 1, 2011
Anticipated Primary Completion Date :
Jun 1, 2012
Anticipated Study Completion Date :
Jun 1, 2012

Arms and Interventions

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

Primary Outcome Measures

  1. Carotid artery (CA) overlap (%) [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 (%) [10 seconds after head positioning]

    IJV safety portion = (1-ovelap distance/IJV diameter) × 100 measured by ultrasound image

  2. overlap distance (mm) [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) [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) [10 seconds after head positioning]

    carotid artery diameter (mm) measured by ultrasound image

  5. IJV diameter (mm) [10 seconds after head positioning]

    internal jugualr vein diameter (mm) measured by ultrasound image

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Month to 12 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Samsung Medical Center Seoul Korea, Republic of 135-710

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Apr 11, 2012
Last Update Posted:
Apr 13, 2012
Last Verified:
Apr 1, 2012
Keywords provided by Jong Hwan Lee, Assistant Professor, Samsung Medical Center

Study Results

No Results Posted as of Apr 13, 2012