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Chris Cairns
© SICS EBM Group 2004
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Femoral vs Subclavian CVC placement, RCT
Lead author's name and fax: Merrer J, jmerrer@chi-poissy-st-germain.fr
Three-part Clinical Question: ICU patients. Subclavian vs Femoral CVC insertion. Infective complications or thrombotic complications.
Search Terms: ICU, CVC, central line, complications, site, femoral, subclavian.
The Study: Non-blinded
concealed randomised controlled trial with intention-to-treat. (micro lab
blinded to catheter site) The Study Patients:
All-comers in general ICU requiring CVC access, first catheter only, randomised
if no contra-indication to either site. Excluded: CVC present on admission, CVC
in the past 15 days, emergency CVC insertion, severe hypoxia, morbid obesity.
Control group (N = 134; 134
analysed): Standardized insertion and routine care protocols. Femoral site. Experimental group (N = 136; 136 analysed): As control group but subclavian site.
The Evidence:
Definitions: 1. Contamination = <1000 colony-forming units/ml and no clinical sepsis 2. Colonization = >1000 colony-forming units/ml and no clinical sepsis 3. Probable catheter-related clinical sepsis without blood stream infection 4. Catheter-related clinical sepsis with bloodstream infection 5. Unable to discriminate between codes 2 and 3 Catheter related infectious complications = 2,3,4 & 5 Major catheter related infectious complications = 3 & 4.
EBM Questions:
1) Do the methods allow accurate testing of the hypothesis? No. The definitions used in the study are not standard. Standard definitions are (1) Catheter colonization – as in this study and (2) CVCrBSI – similar culture results from peripheral blood cultures and line tip cultures or resolution of clinical signs of infection upon removal of the line or positive catheter tip and local infection. If these definitions are used in this studies results we get the following results:
In other words there is not a significant difference in the rate of CVCrBSI. One should also note that there was no study protocol for the aftercare of catheters. There is also a high chance of type II error due to the relatively small sample size.
2) Do the statistical tests correctly test the results to allow differentiation of statistically significant results? Yes, but see comment 1.
3) Are conclusions valid in light of the results? “Femoral venous catheterization is associated with a greater risk of infectious……complications than subclavian catheterization in ICU patients”. There is only a statistically significant difference in colonization rates. This may or may not represent a clinically significant difference. 4) Did results get omitted, and why? 93.4% of patients had their line tips cultured. 5) Did they suggest areas of further research? Yes. A large RCT examining the difference in complications between other CVC site, namely the internal jugular. 6) Did they make any recommendations based on the results and were they appropriate? Yes. That the subclavian site should be used in preference to the femoral site whenever possible. It is difficult to consider infective complications in isolation. There are several other factors to consider when choosing the site of CVC insertion. From a purely infective point of view, in this study at least the femoral site was only associated with an increase in catheter colonization. 7) Is the study relevant to my clinical practice? Yes 8) What level of evidence does this study represent? 1+ 9) What grade of recommendation can I make on this result alone? B 10) What grade of recommendation can I make when this study is considered along with other available evidence? B 11) Should I change my practice because of these results? No. There is no justification in choosing one site over the other on risk of infection grounds alone. 12) Should I audit my current practice because of these results? Yes.
Appraised by: Dr Chris Cairns. Stirling Royal Infirmary.; 05 May 2005
©SICS EGMG 2005
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