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

Infants Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01575184
• Other study ID #: SMC 2011-04-004-001
• Status: Recruiting
• Phase: N/A
• First received: April 10, 2012
• Last updated: April 12, 2012
• Start date: August 2011
• Est. completion date: June 2012

Study information

• Verified date: April 2012
• Source: Samsung Medical Center
• Contact: Jong Hwan Lee, MD, PhD
• Phone: 82-2-3410-1928
• Email: jonghwan75.lee[@]samsung.com
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 12 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Common Carotid Artery
• Infants
• Internal Jugular Vein Cannulation

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	IJV (internal jugular vein) safety portion (%)	IJV safety portion = (1-ovelap distance/IJV diameter) × 100 measured by ultrasound image	10 seconds after head positioning	No
Secondary	overlap distance (mm)	overlap distance (mm) of carotid artery and internal jugular vein measured by ultrasound image	10 seconds after head position	No
Secondary	jugular to carotid distance (mm)	the distance (mm) between lateral border of carotid artery and center of internal jugula vein measured by ultrasound image	10 seconds after head position	No
Secondary	CA diameter (mm)	carotid artery diameter (mm) measured by ultrasound image	10 seconds after head positioning	No
Secondary	IJV diameter (mm)	internal jugualr vein diameter (mm) measured by ultrasound image	10 seconds after head positioning	No