Subclavian Vein catheterization_Seldinger Vs Modified Seldinger (MS)
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|ClinicalTrials.gov Identifier: NCT02090010|
Recruitment Status : Unknown
Verified March 2014 by Hee-Pyoung Park, Seoul National University Hospital.
Recruitment status was: Recruiting
First Posted : March 18, 2014
Last Update Posted : May 13, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain Neoplasm Intracranial Aneurysm Cerebrovascular Moyamoya Disease||Procedure: Seldinger technique Procedure: Modified Seldinger technique||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||418 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Comparison of Two Needle Insertion Techniques on Success Rate and Complications During Subclavian Venous Catheterization: Seldinger vs. Modified Seldinger Technique|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||May 2016|
Active Comparator: GroupC
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.
Procedure: Seldinger 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.
Other Name: thin-wall needle technique
Experimental: Group MS
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.
Procedure: Modified Seldinger 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.
Other Name: guiding sheath-over-the-needle technique
- Major complication rate of subclavian catheterization [ Time Frame: intraoperative ]Compare main complication rates of subclavian catheterization including pnumothorax, hemothorax, arterial puncture, malposition of cathter.
- primary success rate of subclavian catheterization [ Time Frame: intraoperative ]Check the number of attempts of needling, guidewire advance, and catheterization in both groups.
- Total insertion time [ Time Frame: From skin puctuation until confim the successful catheterization anticipated within 3min ]Check the total insertion time from skin puncture to confirm the successful catheterization via venous aspiration though catheter lumen.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02090010
|Contact: Hee Pyung Park, MD PhDemail@example.com|
|Contact: Eugene Kim, MDfirstname.lastname@example.org|
|Korea, Republic of|
|Seoul National University of Hospital||Recruiting|
|Seoul, Korea, Republic of, 110-799|
|Contact: Hee Pyung Park, MD PhD 82-2-2072-2466 email@example.com|
|Contact: Eugene Kim, MD 82-2-2072-2469 firstname.lastname@example.org|
|Principal Investigator: Eugene Kim, MD|
|Study Director:||Hee Pyung Park, MD PhD||Professor|
|Principal Investigator:||Eugene Kim, MD||Clinical Instuctor|