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Clinical Trials/NCT02090010
NCT02090010UnknownNot Applicable

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

Seoul National University Hospital2 sites in 2 countries418 target enrollmentStarted: April 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
418
Locations
2
Primary Endpoint
Major complication rate of subclavian catheterization

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

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.

Intervention: Seldinger technique (Procedure)

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.

Intervention: Modified Seldinger technique (Procedure)

Outcomes

Primary Outcomes

Major complication rate of subclavian catheterization

Time Frame: intraoperative

Compare main complication rates of subclavian catheterization including pnumothorax, hemothorax, arterial puncture, malposition of cathter.

Secondary Outcomes

  • Total insertion time(From skin puctuation until confim the successful catheterization anticipated within 3min)
  • primary success rate of subclavian catheterization(intraoperative)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hee-Pyoung Park

Professor

Seoul National University Hospital

Study Sites (2)

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