Guidance and examination by ultrasound versus landmark and radiographic method for placement of subclavian central venous catheters: study protocol for a randomized controlled trial
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
Trials 2014, 15:175 doi:10.1186/1745-6215-15-175Published: 20 May 2014
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.
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.
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.
ClinicalTrials.gov Identifier: NCT01888094