Internal Jugular Vein CannulationNCT01575184
Effect of Shoulder Traction on Size and Relative Position of Internal Jugular Vein to Carotid Artery
A study testing caudo-ipsilateral traction of shoulder and The ultrasonographic measurements without shoulder traction in people with Internal Jugular Vein Cannulation and Common Carotid Artery, run by Samsung Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 1 month to 12 months
- Conditions the study is for
- Internal Jugular Vein Cannulation, Common Carotid Artery, Infants
- What is being tested?
- caudo-ipsilateral traction of shoulder and The ultrasonographic measurements without shoulder traction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2011to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- infants undergoing elective surgery
Who cannot join
- subjects with congenital heart disease or mass in head and neck
- Subjects with anatomical malformation of great vessels
- previous central venous access via IJV
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 135-710
Jong Hwan Lee, MD, PhD, 82-2-3410-1928, jonghwan75.lee@samsung.com
Won Ho Kim, MD, 82-2-3410-2470, bullet57@naver.com
About this study
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
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.
Read the 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.
- Being tested
- caudo-ipsilateral traction of shoulder, The ultrasonographic measurements without shoulder traction
- Keywords
- internal jugular vein cannulation, common carotid artery, infants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caudo-ipsilateral traction of shoulderOther
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 tractionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Shoulder traction | Experimental | The ultrasonographic measurements with shoulder traction Receives: Other: caudo-ipsilateral traction of shoulder |
| No traction | Active comparator | The ultrasonographic measurements without shoulder traction Receives: Other: The ultrasonographic measurements without shoulder traction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carotid artery (CA) overlap (%)
CA overlap = (overlap distance between CA and internal jugular vein)/CA diameter) × 100 measured by ultrasound image
Measured: 10 seconds after head positioning
Secondary outcomes (5)
IJV (internal jugular vein) safety portion (%)
IJV safety portion = (1-ovelap distance/IJV diameter) × 100 measured by ultrasound image
Measured: 10 seconds after head positioning
overlap distance (mm)
overlap distance (mm) of carotid artery and internal jugular vein measured by ultrasound image
Measured: 10 seconds after head position
jugular to carotid distance (mm)
the distance (mm) between lateral border of carotid artery and center of internal jugula vein measured by ultrasound image
Measured: 10 seconds after head position
CA diameter (mm)
carotid artery diameter (mm) measured by ultrasound image
Measured: 10 seconds after head positioning
IJV diameter (mm)
internal jugualr vein diameter (mm) measured by ultrasound image
Measured: 10 seconds after head positioning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2012 (estimated)
- Study startAug 2011
- Primary completionJun 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Internal Jugular Vein CannulationStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Hwan Lee, Samsung Medical Center
- Investigators
- Jong Hwan Lee, MD, PhD, Principal investigator, Samsung Medical CenterWon Ho Kim, MD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01575184
- Sponsor's protocol ID
- SMC 2011-04-004-001
- Status last verified
- Apr 2012
- First submitted
- 10 Apr 2012
- Last updated
- 13 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01575184
- Acronym / sponsor ID
- SMC 2011-04-004-001
- Keywords
- internal jugular vein cannulation, common carotid artery, infants
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 11 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shoulder traction | Experimental | Other: caudo-ipsilateral traction of shoulderThe ultrasonographic measurements with shoulder traction |
| No traction | Active comparator | Other: The ultrasonographic measurements without shoulder tractionThe ultrasonographic measurements without shoulder traction |
Who may qualify
- Ages
- 1 month to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- infants undergoing elective surgery
Key exclusion criteria (3 listed)
- subjects with congenital heart disease or mass in head and neck
- Subjects with anatomical malformation of great vessels
- previous central venous access via IJV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| caudo-ipsilateral traction of shoulderAfter 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. | Other | Shoulder traction |
| The ultrasonographic measurements without shoulder tractionAfter the head rotation (0, 40, 80 degrees) to the contralateral side from the ultrasound measuring site, the no traction of shoulder will be applied. | Other | No traction |
Primary outcome
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
5 secondary outcomes
IJV (internal jugular vein) safety portion (%)
Time frame: 10 seconds after head positioning
overlap distance (mm)
Time frame: 10 seconds after head position
jugular to carotid distance (mm)
Time frame: 10 seconds after head position
CA diameter (mm)
Time frame: 10 seconds after head positioning
IJV diameter (mm)
Time frame: 10 seconds after head positioning
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jong Hwan Lee, MD, PhD principal investigator
Samsung Medical Center
Won Ho Kim, MD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing caudo-ipsilateral traction of shoulder and The ultrasonographic measurements without shoulder traction in people with Internal Jugular Vein Cannulation and Common Carotid Artery, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jong Hwan Lee, MD, PhD (82-2-3410-1928, jonghwan75.lee@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Carotid artery (CA) overlap (%) (time frame: 10 seconds after head positioning). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2012.