CatheterizationNCT03296735
A Difference in Subclavian Vein Catheterization Between Supine and Lateral Tilt Position - Stage I
A study testing Ipsilateral tilt and Contralateral tilt in people with Catheterization and Posture, run by Seoul National University Hospital.
Trial summary
Central venous catheterization is widely used for various purposes during surgery. For central venous catheterization, subclavian vein is selected because of the relatively low risk of infection, long-term patency and low patient discomfort. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Catheterization, Posture
- What is being tested?
- Ipsilateral tilt and Contralateral tilt
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2017to 31 Jul 2019
- 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 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the patients who receive elective neurosurgical surgery and require central venous catheter
Who cannot join
- the patients who have puncture site infection
- the patients who have chemoport, pacemaker in right subclavian vein
- the patients who had received right mastectomy or right pneumonectomy
- other contraindications for subclavian venous catheterization (eg. mass, hematoma, vegetation, and anticoagulation)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Difference in the Cross-section Area of Subclavian Vein Between Supine and Lateral Tilt Position: Its Clinical Impact on Subclavian Venous Catheterization - Stage II
Central venous catheterization is widely used for various purposes during surgery. For central venous catheterization, subclavian vein is selected because of the relatively low risk of infection, long-term patency and low patient discomfort. The cross - sectional area of the subclavian vein is an important factor to increase success rate. Several studies have reported that the Trendelenburg position increases the cross-sectional area of the subclavian vein, and the lateral tilt position can change the cross-sectional area of the subclavian vein. However, the impact of lateral tilt position to the cross-sectional area of the subclavian vein is not clear. The ipsilateral position can increase the cross-sectional area of the subclavian vein, and the contralateral position can decrease the cross-sectional area by gravity.
In the first stage of this study, we compare the cross-sectional area of subclavian vein using ultrasonography in supine, ipsilateral, and contralateral tilt position.
- Conditions
- Catheterization, Posture
- Being tested
- Ipsilateral tilt, Contralateral tilt
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ipsilateral tiltProcedure or surgery
The operation table will be tilted 20 degrees right laterally.
Contralateral tiltProcedure or surgery
The operation table will be tilted 20 degrees left laterally.
| Study group | Role | What they receive |
|---|---|---|
| Ipsilateral tilt | Experimental | Measuring the cross-sectional area of right subclavian vein in the 20 degree left tilting posture. Receives: Procedure: Ipsilateral tilt |
| Supine | No intervention | Measuring the cross-sectional area of right subclavian vein in supine position. |
| Contralateral tilt | Active comparator | Measuring the cross-sectional area of right subclavian vein in the 20 degree left tilting posture. Receives: Procedure: Contralateral tilt |
What is being measured
The primary outcome is the main question the study is designed to answer.
The cross-sectional area of right subclavian vein
The cross-sectional area of right subclavian vein
Measured: 1 minutes after position change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start15 Oct 2017 (estimated)
- Primary completion31 Jul 2019 (estimated)
- Study completion31 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee-Pyoung Park, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03296735
- Sponsor's protocol ID
- 2017-110-871-1
- Status last verified
- Oct 2017
- First submitted
- 25 Sep 2017
- Last updated
- 11 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yoon HK, Lee HC, Kang P, Lee JM, Park HP, Cho YJ. Effects of ipsilateral tilt position on the cross-sectional area of the subclavian vein and the clinical performance of subclavian vein catheterization: a prospective randomized trial. BMC Anesthesiol. 2020 Sep 5;20(1):226. doi: 10.1186/s12871-020-01144-1.
PubMed 32891115Jung DE, Lee HC, Yoon HK, Park HP. The effects of ipsilateral tilt position on right subclavian venous catheterization: study protocol for a prospective randomized trial. Trials. 2018 May 24;19(1):292. doi: 10.1186/s13063-018-2666-8.
PubMed 29793550
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Difference in the Cross-section Area of Subclavian Vein Between Supine and Lateral Tilt Position: Its Clinical Impact on Subclavian Venous Catheterization - Stage II
- ClinicalTrials.gov ID
- NCT03296735
- Acronym / sponsor ID
- 2017-110-871-1
- Conditions
- Catheterization, Posture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 15 Oct 2017 (estimated)
- Primary completion
- 31 Jul 2019 (estimated)
- Study completion
- 31 Jul 2019 (estimated)
- First posted
- 28 Sep 2017 (actual)
- 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.
Central venous catheterization is widely used for various purposes during surgery. For central venous catheterization, subclavian vein is selected because of the relatively low risk of infection, long-term patency and low patient discomfort. The cross - sectional area of the subclavian vein is an important factor to increase success rate. Several studies have reported that the Trendelenburg position increases the cross-sectional area of the subclavian vein, and the lateral tilt position can change the cross-sectional area of the subclavian vein. However, the impact of lateral tilt position to the cross-sectional area of the subclavian vein is not clear. The ipsilateral position can increase the cross-sectional area of the subclavian vein, and the contralateral position can decrease the cross-sectional area by gravity.
In the first stage of this study, we compare the cross-sectional area of subclavian vein using ultrasonography in supine, ipsilateral, and contralateral tilt position.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ipsilateral tilt | Experimental | Procedure: Ipsilateral tiltMeasuring the cross-sectional area of right subclavian vein in the 20 degree left tilting posture. |
| Supine | No intervention | –Measuring the cross-sectional area of right subclavian vein in supine position. |
| Contralateral tilt | Active comparator | Procedure: Contralateral tiltMeasuring the cross-sectional area of right subclavian vein in the 20 degree left tilting posture. |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- the patients who receive elective neurosurgical surgery and require central venous catheter
Key exclusion criteria (4 listed)
- the patients who have puncture site infection
- the patients who have chemoport, pacemaker in right subclavian vein
- the patients who had received right mastectomy or right pneumonectomy
- other contraindications for subclavian venous catheterization (eg. mass, hematoma, vegetation, and anticoagulation)
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 |
|---|---|---|
| Ipsilateral tiltThe operation table will be tilted 20 degrees right laterally. | Procedure or surgery | Ipsilateral tilt |
| Contralateral tiltThe operation table will be tilted 20 degrees left laterally. | Procedure or surgery | Contralateral tilt |
Primary outcome
The cross-sectional area of right subclavian vein
Time frame: 1 minutes after position change
The cross-sectional area of right subclavian vein
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2017.
- Derived from this study: PubMed 32891115Yoon HK, Lee HC, Kang P, Lee JM, Park HP, Cho YJ. Effects of ipsilateral tilt position on the cross-sectional area of the subclavian vein and the clinical performance of subclavian vein catheterization: a prospective randomized trial. BMC Anesthesiol. 2020 Sep 5;20(1):226. doi: 10.1186/s12871-020-01144-1.
- Derived from this study: PubMed 29793550Jung DE, Lee HC, Yoon HK, Park HP. The effects of ipsilateral tilt position on right subclavian venous catheterization: study protocol for a prospective randomized trial. Trials. 2018 May 24;19(1):292. doi: 10.1186/s13063-018-2666-8.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Ipsilateral tilt and Contralateral tilt in people with Catheterization and Posture, run by Seoul National University Hospital.
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 4 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 11 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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 Hyung-Chul Lee, MD (+82-10-2456-6336, lucid80@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The cross-sectional area of right subclavian vein (time frame: 1 minutes after position change). 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 NCT03296735, which also lists 2 linked publications.
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 11 Oct 2017.