Subclavian Venous CatheterizationNCT02478749
Influence of Arm Retraction on the Supraclavicular Approach for Subclavian Vein Catheterization
A study testing arm retraction in people with Subclavian Venous Catheterization, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to determine the effect of arm retraction on the supraclavicular approach for subclavian vein catheterization in adults and children. Read more about this study
- Who is it for?
- Ages Up to 60 years
- Conditions the study is for
- Subclavian Venous Catheterization
- What is being tested?
- arm retraction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2015to Jul 2015
- 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 Up to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- patients undergoing general anesthesia regardless of subclavian venous catheterization
Who cannot join
- patients with infection over the puncture site history of thoracic surgery or clavicular fracture vascular malformation anatomical abnormality of subclavian vein
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Seoul, 110-744
About this study
Official title: Influence of Arm Retraction on the Relative Position of Clavicle and the Subclavian Vein,During Supraclavicular Approach for Central Venous Catheterization in Adults and Children
The purpose of this study is to determine the effect of arm retraction on the supraclavicular approach for subclavian vein catheterization in adults and children.
- Conditions
- Subclavian Venous Catheterization
- Being tested
- arm retraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arm retractionProcedure or surgery
gently pulling through the ipsilateral arm to the knee
| Study group | Role | What they receive |
|---|---|---|
| Infant | Experimental | patients aged younger than 1year Receives: Procedure: arm retraction |
| Child | Experimental | patients aged 1year to 5years Receives: Procedure: arm retraction |
| Adult | Experimental | adult patients Receives: Procedure: arm retraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of distance between clavicle and confluence of internal jugular vein and subclavian vein while arm retraction
Measured: Outcome measure will be assessed during arm retraction and it would be within 30 second of arm retraction
Change in diameter of suvclavian vein at the confluence of internal jugular vein and subclavian vein
Measured: Outcome measure will be assessed during arm retraction and it would be within 30 second of arm retraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionJul 2015
- Study completionJul 2015
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 Venous 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
- Investigators
- Jintae Kim, MD.PhD., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02478749
- Sponsor's protocol ID
- H-1504-069-664
- Status last verified
- Feb 2016
- First submitted
- 1 Jun 2015
- Last updated
- 24 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kim EH, Lee JH, Song IK, Kim HC, Kim HS, Kim JT. Influence of caudal traction of ipsilateral arm on ultrasound image for supraclavicular central venous catheterization. Am J Emerg Med. 2016 May;34(5):851-5. doi: 10.1016/j.ajem.2016.01.038. Epub 2016 Feb 12.
PubMed 26947376
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Arm Retraction on the Relative Position of Clavicle and the Subclavian Vein,During Supraclavicular Approach for Central Venous Catheterization in Adults and Children
- ClinicalTrials.gov ID
- NCT02478749
- Acronym / sponsor ID
- H-1504-069-664
- Conditions
- Subclavian Venous Catheterization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 23 Jun 2015 (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 the effect of arm retraction on the supraclavicular approach for subclavian vein catheterization in adults and children.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Infant | Experimental | Procedure: arm retractionpatients aged younger than 1year |
| Child | Experimental | Procedure: arm retractionpatients aged 1year to 5years |
| Adult | Experimental | Procedure: arm retractionadult patients |
Who may qualify
- Ages
- Up to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- patients undergoing general anesthesia regardless of subclavian venous catheterization
Key exclusion criteria (1 listed)
- patients with infection over the puncture site history of thoracic surgery or clavicular fracture vascular malformation anatomical abnormality 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 |
|---|---|---|
| arm retractiongently pulling through the ipsilateral arm to the knee | Procedure or surgery | Adult, Child, Infant |
Primary outcome
Change of distance between clavicle and confluence of internal jugular vein and subclavian vein while arm retraction
Time frame: Outcome measure will be assessed during arm retraction and it would be within 30 second of arm retraction
Change in diameter of suvclavian vein at the confluence of internal jugular vein and subclavian vein
Time frame: Outcome measure will be assessed during arm retraction and it would be within 30 second of arm retraction
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 24 Feb 2016.
- Derived from this study: PubMed 26947376Kim EH, Lee JH, Song IK, Kim HC, Kim HS, Kim JT. Influence of caudal traction of ipsilateral arm on ultrasound image for supraclavicular central venous catheterization. Am J Emerg Med. 2016 May;34(5):851-5. doi: 10.1016/j.ajem.2016.01.038. Epub 2016 Feb 12.
Related trials for Subclavian Venous Catheterization
Recruiting
Central Vein Stenosis Due to Dialysis Catheter Insertion in Subclavian Compared to Jugular Vein
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.
Jintae Kim, MD.PhD. principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing arm retraction in people with Subclavian Venous 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 1 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 24 Feb 2016. 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?
Change of distance between clavicle and confluence of internal jugular vein and subclavian vein while arm retraction (time frame: Outcome measure will be assessed during arm retraction and it would be within 30 second of arm retraction). The study lists 2 primary outcomes in all. 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 NCT02478749, 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 24 Feb 2016.