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Open Access Study protocol

Guidance and examination by ultrasound versus landmark and radiographic method for placement of subclavian central venous catheters: study protocol for a randomized controlled trial

Sébastien Perbet12*, Bruno Pereira3, Florian Grimaldi1, Christian Dualé4, Jean-Etienne Bazin1 and Jean-Michel Constantin12

Author Affiliations

1 Department of Anesthesiology and Critical Care Medicine, CHU Estaing, CHU Clermont-Ferrand, Intensive Care Unit, F-63000 Clermont-Ferrand, France

2 Université d’Auvergne, D2R2, EA-7281, Faculty of Medicine, 28 Place Henri Dunant, F-63001 Clermont-Ferrand, France

3 CHU Clermont-Ferrand, Biostatistics Unit, DRCI, CHU Gabriel-Montpied, F-63003 Clermont-Ferrand, France

4 CHU Clermont-Ferrand, Centre d’Investigations cliniques, CHU Gabriel-Montpied, F-63003 Clermont-Ferrand, France

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Trials 2014, 15:175  doi:10.1186/1745-6215-15-175

Published: 20 May 2014

Abstract

Background

Central venous catheters play an important role in patient care. Real-time ultrasound-guided subclavian central venous (SCV) cannulation may reduce the incidence of complications and the time between skin penetration and the aspiration of venous blood into the syringe. Ultrasonic diagnosis of catheter misplacement and pneumothorax related to central venous catheterization is rapid and accurate. It is unclear, however, whether ultrasound real-time guidance and examination can reduce procedure times and complication rates when compared with landmark guidance and radiographic examination for SCV catheterization.

Methods/Design

The Subclavian Central Venous Catheters Guidance and Examination by UltraSound (SUBGEUS) study is an investigator-initiated single center, randomized, controlled two-arm trial. Three hundred patients undergoing SCV catheter placement will be randomized to ultrasound real-time guidance and examination or landmark guidance and radiographic examination. The primary outcome is the time between the beginning of the procedure and control of the catheter. Secondary outcomes include the times required for the six components of the total procedure, the occurrence of complications (pneumothorax, hemothorax, or misplacement), failure of the technique and occurrence of central venous catheter infections.

Discussion

The SUBGEUS trial is the first randomized controlled study to investigate whether ultrasound real-time guidance and examination for SCV catheter placement reduces all procedure times and the rate of complications.

Trial registration

ClinicalTrials.gov Identifier: NCT01888094

Keywords:
central venous catheter; subclavian vein; ultrasound guidance; pulmonary ultrasound; cardiac ultrasound; contrast test