Brain NeoplasmMSNCT02090010
Subclavian Vein catheterization_Seldinger Vs Modified Seldinger
A study testing Seldinger technique and Modified Seldinger technique in people with Brain Neoplasm and Intracranial Aneurysm, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Seldinger technique is a minimally invasive technique in which the practitioner accesses the target vessel with a small bore needle, then dilates to the size required for the catheter. Contrarily, modified Seldinger technique(guiding sheath-over-the-needle technique) use needle that is covered with guiding sheath. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Brain Neoplasm, Intracranial Aneurysm, Cerebrovascular Moyamoya Disease
- What is being tested?
- Seldinger technique and Modified Seldinger technique
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 418 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2014to May 2016
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient scheduled for surgery under genearl anesthesia and subclavian vein central catheterization
Who cannot join
- Patient who does not agree to the study
- Inflammation or infection on catheterization site
- Contralateral diaphragmatic dysfunction
- Anatomic anomalies of subclavian artery or vein/clavicle
- Previous lung surgical history
- Patient who has ventriculoperitoneal shunt or chemoport on same side
- Patient who has pneumo/hemothorax or lung parenchymal disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University of Hospital
Seoul, 110-799
Hee Pyung Park, MD PhD, 82-2-2072-2466, hppark@snu.ac.kr
Eugene Kim, MD, 82-2-2072-2469, tomomie@hanmail.net
About this study
Official title: Comparison of Two Needle Insertion Techniques on Success Rate and Complications During Subclavian Venous Catheterization: Seldinger vs. Modified Seldinger Technique
Seldinger technique is a minimally invasive technique in which the practitioner accesses the target vessel with a small bore needle, then dilates to the size required for the catheter. Contrarily, modified Seldinger technique(guiding sheath-over-the-needle technique) use needle that is covered with guiding sheath.
Both technique is widely used in central venous catheterization, however, few researches have been investigated to compare success rate or complications of both methods.
Read the detailed description
The major complications of central venous catheterization through subclavian vein, are unintended arterial puncture, pneumothorax, hemothorax, malposition of catheter etc,. We assume that using modified Seldinger technique (MST), guiding sheath is easily slid over the needle, providing stable route into the vessel lumen relatively.
We aimed to compare the Seldinger technique and modified Seldinger technique(MST) on success rate and complications during subclavian central venous catheterization in this prospective, randomized , controlled trials.
- Being tested
- Seldinger technique, Modified Seldinger technique
- Medical subject headings
- Brain Neoplasms, Intracranial Aneurysm, Moyamoya Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seldinger techniqueProcedure or surgery
Also called thin-wall needle technique
The aimed vessel(subclavian vein) is punctured with a sharp hollow needle, syringe is detached and guidewire is advanced through the lumen of the needle, and the needle is removed.
After that catheter is passed over the guidewire into the vessel.
Modified Seldinger techniqueProcedure or surgery
Also called guiding sheath-over-the-needle technique
The aimed vessel is punctured with the needle that is covered with guiding sheath. After vessel is punctured, guiding sheath is instantly slid over the needle into the vessel. The needle is removed, guidewire is advanced through the sheath, central catheter is placed into the vessel.
| Study group | Role | What they receive |
|---|---|---|
| GroupC | Active comparator | Group C means Control group which use Seldinger technique for subclavian catheterization. The aimed vessel(subclavian vein) is punctured with a sharp hollow needle, syringe is detached and guidewire is advanced through the lumen of the needle, and the needle is removed. After that catheter is passed over the guidewire into the vessel. Receives: Procedure: Seldinger technique |
| Group MS | Experimental | Group MS means experimental group which use modified Seldinger technique for subclavian catheterization. The aimed vessel is punctured with the needle that is covered with guiding sheath. After vessel is punctured, guiding sheath is instatntly slid over the needle into the vessel. The needle is removed, guidewire is advanced through the sheath, central catheter is placed into the vessel. Receives: Procedure: Modified Seldinger technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major complication rate of subclavian catheterization
Compare main complication rates of subclavian catheterization including pnumothorax, hemothorax, arterial puncture, malposition of cathter.
Measured: intraoperative
Secondary outcomes (2)
primary success rate of subclavian catheterization
Check the number of attempts of needling, guidewire advance, and catheterization in both groups.
Measured: intraoperative
Total insertion time
Check the total insertion time from skin puncture to confirm the successful catheterization via venous aspiration though catheter lumen.
Measured: From skin puctuation until confim the successful catheterization anticipated within 3min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain NeoplasmStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 418 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
- Investigators
- Hee Pyung Park, MD PhD, Study director, ProfessorEugene Kim, MD, Principal investigator, Clinical Instuctor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02090010
- Sponsor's protocol ID
- Modified seldinger
- Acronym
- MS
- Status last verified
- Mar 2014
- First submitted
- 16 Mar 2014
- Last updated
- 13 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Needle Insertion Techniques on Success Rate and Complications During Subclavian Venous Catheterization: Seldinger vs. Modified Seldinger Technique
- ClinicalTrials.gov ID
- NCT02090010
- Acronym / sponsor ID
- MS / Modified seldinger
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 418 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- May 2016 (estimated)
- First posted
- 18 Mar 2014 (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.
Seldinger technique is a minimally invasive technique in which the practitioner accesses the target vessel with a small bore needle, then dilates to the size required for the catheter. Contrarily, modified Seldinger technique(guiding sheath-over-the-needle technique) use needle that is covered with guiding sheath.
Both technique is widely used in central venous catheterization, however, few researches have been investigated to compare success rate or complications of both methods.
Detailed description
The major complications of central venous catheterization through subclavian vein, are unintended arterial puncture, pneumothorax, hemothorax, malposition of catheter etc,. We assume that using modified Seldinger technique (MST), guiding sheath is easily slid over the needle, providing stable route into the vessel lumen relatively.
We aimed to compare the Seldinger technique and modified Seldinger technique(MST) on success rate and complications during subclavian central venous catheterization in this prospective, randomized , controlled trials.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GroupC | Active comparator | Procedure: Seldinger techniqueGroup C means Control group which use Seldinger technique for subclavian catheterization. The aimed vessel(subclavian vein) is punctured with a sharp hollow needle, syringe is detached and guidewire is advanced through the lumen of the needle, and the needle is removed. After that catheter is passed over the guidewire into the vessel. |
| Group MS | Experimental | Procedure: Modified Seldinger techniqueGroup MS means experimental group which use modified Seldinger technique for subclavian catheterization. The aimed vessel is punctured with the needle that is covered with guiding sheath. After vessel is punctured, guiding sheath is instatntly slid over the needle into the vessel. The needle is removed, guidewire is advanced through the sheath, central catheter is placed into the vessel. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patient scheduled for surgery under genearl anesthesia and subclavian vein central catheterization
Key exclusion criteria (7 listed)
- Patient who does not agree to the study
- Inflammation or infection on catheterization site
- Contralateral diaphragmatic dysfunction
- Anatomic anomalies of subclavian artery or vein/clavicle
- Previous lung surgical history
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 |
|---|---|---|
| Seldinger techniqueAlso: thin-wall needle techniqueThe aimed vessel(subclavian vein) is punctured with a sharp hollow needle, syringe is detached and guidewire is advanced through the lumen of the needle, and the needle is removed. After that catheter is passed over the guidewire into the vessel. | Procedure or surgery | GroupC |
| Modified Seldinger techniqueAlso: guiding sheath-over-the-needle techniqueThe aimed vessel is punctured with the needle that is covered with guiding sheath. After vessel is punctured, guiding sheath is instantly slid over the needle into the vessel. The needle is removed, guidewire is advanced through the sheath, central catheter is placed into the vessel. | Procedure or surgery | Group MS |
Primary outcome
Major complication rate of subclavian catheterization
Time frame: intraoperative
Compare main complication rates of subclavian catheterization including pnumothorax, hemothorax, arterial puncture, malposition of cathter.
2 secondary outcomes
primary success rate of subclavian catheterization
Time frame: intraoperative
Total insertion time
Time frame: From skin puctuation until confim the successful catheterization anticipated within 3min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2014.
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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.
Hee Pyung Park, MD PhD study director
Professor
Eugene Kim, MD principal investigator
Clinical Instuctor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Seldinger technique and Modified Seldinger technique in people with Brain Neoplasm and Intracranial Aneurysm, 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 7 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 May 2014. 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 Hee Pyung Park, MD PhD (82-2-2072-2466, hppark@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major complication rate of subclavian catheterization (time frame: intraoperative). 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 May 2014.