- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01575184
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
Study Overview
Status
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jong Hwan Lee, MD, PhD
- Phone Number: 82-2-3410-1928
- Email: jonghwan75.lee@samsung.com
Study Contact Backup
- Name: Ae Ryoung Lee, MD
- Phone Number: 82-2-3410-1929
- Email: nanrong.lee@samsung.com
Study Locations
-
-
-
Seoul, Korea, Republic of, 135-710
- Recruiting
- Samsung Medical Center
-
Contact:
- Won Ho Kim, MD
- Phone Number: 82-2-3410-2470
- Email: bullet57@naver.com
-
Contact:
- Jong Hwan Lee, MD, PhD
- Phone Number: 82-2-3410-1928
- Email: jonghwan75.lee@samsung.com
-
Sub-Investigator:
- Jong Hwan Lee, MD, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Shoulder traction
The ultrasonographic measurements with shoulder traction
|
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
10 seconds after head positioning
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
10 seconds after head positioning
|
overlap distance (mm)
Time Frame: 10 seconds after head position
|
overlap distance (mm) of carotid artery and internal jugular vein measured by ultrasound image
|
10 seconds after head position
|
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
|
10 seconds after head position
|
CA diameter (mm)
Time Frame: 10 seconds after head positioning
|
carotid artery diameter (mm) measured by ultrasound image
|
10 seconds after head positioning
|
IJV diameter (mm)
Time Frame: 10 seconds after head positioning
|
internal jugualr vein diameter (mm) measured by ultrasound image
|
10 seconds after head positioning
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SMC 2011-04-004-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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