Subclavian Vein CatheterizationNCT01368692
Effect of Shoulder Retraction on Success Rate of Subclavian Vein Catheterization
A study testing position of shoulder retraction and position of neutral shoulder in people with Subclavian Vein Catheterization, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to determine whether the shoulder retraction by placing a saline bag between the scapula influences a success rate of subclavian vein catheterization. Read more about this study
- Who is it for?
- Ages 16 to 82 years
- Conditions the study is for
- Subclavian Vein Catheterization
- What is being tested?
- position of shoulder retraction and position of neutral shoulder
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 362 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2011to Jan 2013
- 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 16 to 82 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- adult patients undergoing neurosurgery or thoracic surgery that requires the placement of subclavian venous catheterization
Who cannot join
- infection over the puncture site
- history of prior clavicular fracture
- anatomical anomaly of subclavian vein
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether the shoulder retraction by placing a saline bag between the scapula influences a success rate of subclavian vein catheterization.
- Conditions
- Subclavian Vein Catheterization
- Being tested
- position of shoulder retraction, position of neutral shoulder
- Keywords
- subclavian vein catheterization success rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
position of shoulder retractionProcedure or surgery
position of shoulder retraction by placing a saline bag between the scapula
position of neutral shoulderProcedure or surgery
neutral shoulder position during subclavian vein catheterization
| Study group | Role | What they receive |
|---|---|---|
| neutral shoulder | Active comparator | neutral shoulder position during subclavian vein catheterization Receives: Procedure: position of neutral shoulder |
| shoulder retraction | Experimental | position of shoulder retraction during subclavian vein catheterization Receives: Procedure: position of shoulder retraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
catheterization success rate
Subclavian vein catheterization will be performed after the induction of anesthesia and before the start of surgery.
Measured: immediately after catheterization (an expected average of 1 hour)
Secondary outcomes (1)
location of catheter tip
Postoperative chest X-ray will be taken to check for the location of catheter tip immediately after surgery.
Measured: an expected average of one day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionMay 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Subclavian Vein CatheterizationStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 362 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae-Hyon Bahk, MD, PhD, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01368692
- Sponsor's protocol ID
- H-1103-124-357
- Status last verified
- Jan 2013
- First submitted
- 22 May 2011
- Last updated
- 15 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Kim HJ, Jung SH, Min J, Hong DM, Jeon Y, Bahk JH. Comparison of the neutral and retracted shoulder positions for infraclavicular subclavian venous catheterization: a randomized, non-inferiority trial. Br J Anaesth. 2013 Aug;111(2):191-6. doi: 10.1093/bja/aet026. Epub 2013 Mar 10.
PubMed 23479675
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Shoulder Retraction on Success Rate of Subclavian Vein Catheterization
- ClinicalTrials.gov ID
- NCT01368692
- Acronym / sponsor ID
- H-1103-124-357
- Conditions
- Subclavian Vein Catheterization
- Keywords
- subclavian vein catheterization success rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 362 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- May 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 8 Jun 2011 (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.
The purpose of this study is to determine whether the shoulder retraction by placing a saline bag between the scapula influences a success rate of subclavian vein catheterization.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| neutral shoulder | Active comparator | Procedure: position of neutral shoulderneutral shoulder position during subclavian vein catheterization |
| shoulder retraction | Experimental | Procedure: position of shoulder retractionposition of shoulder retraction during subclavian vein catheterization |
Who may qualify
- Ages
- 16 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients undergoing neurosurgery or thoracic surgery that requires the placement of subclavian venous catheterization
Key exclusion criteria (3 listed)
- infection over the puncture site
- history of prior clavicular fracture
- anatomical anomaly of subclavian vein
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 |
|---|---|---|
| position of shoulder retractionposition of shoulder retraction by placing a saline bag between the scapula | Procedure or surgery | shoulder retraction |
| position of neutral shoulderneutral shoulder position during subclavian vein catheterization | Procedure or surgery | neutral shoulder |
Primary outcome
catheterization success rate
Time frame: immediately after catheterization (an expected average of 1 hour)
Subclavian vein catheterization will be performed after the induction of anesthesia and before the start of surgery.
1 secondary outcome
location of catheter tip
Time frame: an expected average of one day after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2013.
- Derived from this study: PubMed 23479675Kim HJ, Jung SH, Min J, Hong DM, Jeon Y, Bahk JH. Comparison of the neutral and retracted shoulder positions for infraclavicular subclavian venous catheterization: a randomized, non-inferiority trial. Br J Anaesth. 2013 Aug;111(2):191-6. doi: 10.1093/bja/aet026. Epub 2013 Mar 10.
Related trials for Subclavian Vein Catheterization
Recruiting
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Subclavian Vein Stenosis, Jugular Vein Occlusion
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing position of shoulder retraction and position of neutral shoulder in people with Subclavian Vein Catheterization, run by Seoul National University Hospital 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: finished, as of the sponsor's last update on 15 Jan 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
catheterization success rate (time frame: immediately after catheterization (an expected average of 1 hour)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01368692, which also lists 1 linked publication.
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 15 Jan 2013.