Subclavian Vein catheterization_Seldinger Vs Modified Seldinger

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Two Needle Insertion Techniques on Success Rate and Complications During Subclavian Venous Catheterization: Seldinger vs. Modified Seldinger Technique

Conditions
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Brain Neoplasm, Intracranial Aneurysm, Cerebrovascular Moyamoya Disease

Intervention / Treatment
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* Procedure: Seldinger technique
* Procedure: Modified Seldinger technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient scheduled for surgery under genearl anesthesia and subclavian vein central catheterization Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: GroupC<br>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<br>* 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.<br>* Other names: thin-wall needle technique;|
| Experimental: Group MS<br>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<br>* 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.<br>* Other names: guiding sheath-over-the-needle technique;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major complication rate of subclavian catheterization | Compare main complication rates of subclavian catheterization including pnumothorax, hemothorax, arterial puncture, malposition of cathter. | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| primary success rate of subclavian catheterization | Check the number of attempts of needling, guidewire advance, and catheterization in both groups. | intraoperative | 
| Total insertion time | Check the total insertion time from skin puncture to confirm the successful catheterization via venous aspiration though catheter lumen. | From skin puctuation until confim the successful catheterization anticipated within 3min |