COSMOS - a study comparing peripheral intravenous systems.

In many areas of the world, safety peripheral intravenous systems have come into widespread use. The Madrid region was the first in Spain to adopt such an approach. These systems, though initially introduced to protect users from sharps injuries, have now evolved to include patient protection features as well. Patient protection, simply stated, means closing the system to pathogen entry. The authors' purpose was to investigate, in a prospective and randomized study, the clinical performance of a closed safe intravenous system versus an open system (COSMOS - Compact Closed System versus Mounted Open System). COSMOS is designed to provide definitive answers, from a nursing perspective, to many topics related to peripheral venous catheterization, which have important implications in intravenous therapy and which have not been validated scientifically. Furthermore, it forms pioneering research in that it is the first clinical trial on medical devices in a legislated environment carried out entirely by nurses and whose promoter and principal investigator is a nurse. The objectives of COSMOS are to compare the effectiveness (as defined by time of survival without complications) and rates of catheter-related complications, such as phlebitis, pain, extravasation, blockage and catheter-related infections. It also looks at rates of catheter colonization, the ease of handling of both systems and overall costs. This article outlines the authors' approach, both in preparing hospital units for such an evaluation as well as in the choice of parameters and their method of study. Further articles will detail the results and findings of the study.