The primary outcome was phlebitis, with a prespecified equivalence margin of 3%. In both groups, phlebitis occurred in 7% of patients (RR=1.06; 95% CI, 0.83-1.36; P=.64). The absolute risk difference was 0.41% (95% CI, -1.33 to 2.15), which was within the equivalence margin.
The mean IV catheter dwell time was 70 hours in the routine replacement group and 99 hours in the clinically indicated group. Nine patients in the routine replacement group developed bloodstream infections, vs 4 patients in the clinically indicated group (hazard ratio=0.46; 95% CI, 0.14-1.48; P=.19). One patient in the routine placement group had a catheter-related bloodstream infection; no one in the clinically indicated group did. The mortality rate for each group was <1%.
WHAT’S NEW: We can order clinically indicated IV replacement with confidence
The findings of this equivalence trial support prior studies and add greater statistical power. The results suggest that we can recommend clinically indicated replacement of peripheral IV catheters without increasing the rate of phlebitis. Implementing clinically indicated replacement of IVs could decrease hospital costs and improve patient satisfaction.
CAVEATS: Findings do not apply to patients with bacteremia
Patients with known bacteremia were excluded from this study, and the results are therefore not generalizable to this population.
The nonblinded nature of this trial raises the possibility of observer and reporting bias. However, measures were taken to minimize the potential for bias. A structured outcome assessment was used to standardize reporting of signs of phlebitis. Both patients’ pain scores and nurses’ assessments of the IV sites were used to determine whether an infection was present, and the investigators and research nurses were not involved in the removal of the IV catheters.
This study did not report on the daily maintenance protocols the investigators used for the peripheral IVs. The study was conducted in hospitals in Australia, and we don’t know whether the protocols used in that country are similar to standard protocols in US hospitals.
CHALLENGES TO IMPLEMENTATION: Changing hospital protocols won’t be easy
Implementing the findings of this study will require that physicians work with the nursing staff and administrators to create and implement new protocols for assessing peripheral IV catheters in hospitals with routine IV replacement policies already in place. It would be necessary to ensure that all clinicians who place peripheral IV catheters are taught the clinical signs of phlebitis and are using a standardized protocol. That said, we think that this is a worthwhile change to achieve the long-term benefits of fewer unnecessary IV catheter replacements.
Acknowledgement
The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center for Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center for Research Resources or the National Institutes of Health.
