Subclavian Vein catheterization_Seldinger Vs Modified Seldinger

Not Applicable

• Conditions: Brain Neoplasm; Intracranial Aneurysm; Cerebrovascular Moyamoya Disease
• Interventions: Procedure: Modified Seldinger technique; Procedure: Seldinger technique

• Registration Number: NCT02090010
• Lead Sponsor: Seoul National University Hospital

Brief 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.

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 Timeline

• Status Verified: 2014-03
• Study First Submitted: 2014-03-16
• Study First Submitted QC: 2014-03-17
• Study First Posted: 2014-03-18
• Study Start: 2014-04
• Last Update Submitted: 2014-05-11
• Last Update Posted: 2014-05-13
• Primary Completion: 2016-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 418

Inclusion Criteria

• patient scheduled for surgery under genearl anesthesia and subclavian vein central catheterization

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group MS	Modified Seldinger technique	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.
GroupC	Seldinger technique	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.

Primary Outcome Measures

Name	Time	Method
Major complication rate of subclavian catheterization	intraoperative	Compare main complication rates of subclavian catheterization including pnumothorax, hemothorax, arterial puncture, malposition of cathter.

Secondary Outcome Measures

Name	Time	Method
Total insertion time	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.
primary success rate of subclavian catheterization	intraoperative	Check the number of attempts of needling, guidewire advance, and catheterization in both groups.

Trial Locations

Locations (1)

Seoul National University of Hospital; 🇰🇷 Seoul, Korea, Republic of