Catheter Tip LocationNCT01024881
Influence of the Shoulder Position on the Catheter Tip Location During Infraclavicular Subclavian Approach
A study testing neutral shoulder position and lowered shoulder position in people with Catheter Tip Location, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Infraclavicular approach of the subclavian veins is commonly used for central venous access. Aberrant locations of catheter tip are frequently quoted for this approach, but few studies have been performed to document the relationship between the shoulder position and catheter tip location. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Catheter Tip Location
- What is being tested?
- neutral shoulder position and lowered shoulder position
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 344 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2008to Aug 2009
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients requiring central venous catheterization due to major procedures such as neurosurgery or thoracic surgery.
Who cannot join
- chest deformities,
- coagulopathy,
- diaphragmatic dysfunction,
- pulmonary malformation,
- history of prior clavicle fracture, or
- infection over the puncture site.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Seoul, 110-744
About this study
Infraclavicular approach of the subclavian veins is commonly used for central venous access. Aberrant locations of catheter tip are frequently quoted for this approach, but few studies have been performed to document the relationship between the shoulder position and catheter tip location. This prospective study was performed to assess the influence of the shoulder position on the safe and proper placement of infraclavicular subclavian catheters.
- Conditions
- Catheter Tip Location
- Being tested
- neutral shoulder position, lowered shoulder position
- Keywords
- catheterization success rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neutral shoulder positionProcedure or surgery
neutral shoulder position during infraclavicular subclavian catheterization
lowered shoulder positionProcedure or surgery
lowered shoulder position during infraclavicular subclavian catheterization
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Active comparator | neutral shoulder position during infraclavicular subclavian catheterization Receives: Procedure: neutral shoulder position |
| group 2 | Experimental | lowered shoulder position during infraclavicular subclavian catheterization Receives: Procedure: lowered shoulder position |
What is being measured
The primary outcome is the main question the study is designed to answer.
location of the catheter tip
Measured: at the end of surgery
Secondary outcomes (1)
catheterization success rate
Measured: immediately after catheterization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2009 (estimated)
- Study startDec 2008
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter Tip LocationStudies 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
- 344 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01024881
- Sponsor's protocol ID
- JHBahk_CVC shoulder position
- Status last verified
- Dec 2009
- First submitted
- 2 Dec 2009
- Last updated
- 3 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the Shoulder Position on the Catheter Tip Location During Infraclavicular Subclavian Approach
- ClinicalTrials.gov ID
- NCT01024881
- Acronym / sponsor ID
- JHBahk_CVC shoulder position
- Conditions
- Catheter Tip Location
- Keywords
- catheterization success rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 344 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 3 Dec 2009 (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.
Infraclavicular approach of the subclavian veins is commonly used for central venous access. Aberrant locations of catheter tip are frequently quoted for this approach, but few studies have been performed to document the relationship between the shoulder position and catheter tip location. This prospective study was performed to assess the influence of the shoulder position on the safe and proper placement of infraclavicular subclavian catheters.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | Active comparator | Procedure: neutral shoulder positionneutral shoulder position during infraclavicular subclavian catheterization |
| group 2 | Experimental | Procedure: lowered shoulder positionlowered shoulder position during infraclavicular subclavian catheterization |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients requiring central venous catheterization due to major procedures such as neurosurgery or thoracic surgery.
Key exclusion criteria (6 listed)
- chest deformities,
- coagulopathy,
- diaphragmatic dysfunction,
- pulmonary malformation,
- history of prior clavicle fracture, or
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 |
|---|---|---|
| neutral shoulder positionneutral shoulder position during infraclavicular subclavian catheterization | Procedure or surgery | group 1 |
| lowered shoulder positionlowered shoulder position during infraclavicular subclavian catheterization | Procedure or surgery | group 2 |
Primary outcome
location of the catheter tip
Time frame: at the end of surgery
1 secondary outcome
catheterization success rate
Time frame: immediately after catheterization
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 3 Dec 2009.
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 neutral shoulder position and lowered shoulder position in people with Catheter Tip Location, 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 6 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 3 Dec 2009. 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?
location of the catheter tip (time frame: at the end of surgery). 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 3 Dec 2009.