PURPOSE: To quantify the morbidity and mortality of ventilator-associated pneumonia (VAP) in a phase III multicenter study of an endotracheal tube coated with silver ions microdispersed in a proprietary polymer (Agento™ I. C., C. R. Bard, Inc.) designed to reduce VAP incidence by preventing bacterial colonization and biofilm formation.
METHODS: Patients expected to require mechanical ventilation for ≥24 hours were randomly assigned to intubation with the silver-coated endotracheal tube or a control tube (Hi-Lo Endotracheal Tube, Mallinckrodt). Primary outcome of the phase III multicenter study was VAP incidence based on quantitative bronchoalveolar lavage (BAL) fluid culture with ≥10000 colony-forming units (CFU)/mL. Outcomes in the post hoc analysis of patients with and without VAP were durations of intubation, intensive care unit (ICU) stay, and hospital stay and rate of mortality.
RESULTS: In the post hoc analysis of all patients intubated for ≥24 hours, VAP was associated with longer durations of intubation (median for VAP versus no VAP, 10.0 versus 3.8 days; p<0.0001), ICU stay (18.0 versus 7.0 days; p<0.0001), and hospital stay (27.0 versus 15.0 days; p<0.0001). VAP was not shown to be associated with a higher mortality rate (26.9% [25/93 patients] versus 28.7% [406/1416]; p=0.71). In the phase III multicenter study, the incidence of microbiologically-confirmed VAP was higher in the control group than in the silver group (control versus silver, 7.5% [56/743 patients] versus 4.8% [37/766]; p=0.03).
CONCLUSION: The findings of the post hoc analysis suggest that microbiologically-confirmed VAP continues to be associated with unacceptably high rates of morbidity and that preventing VAP can reduce durations of intubation, ICU stay, and hospital stay. In the phase III multicenter study, the silver-coated endotracheal tube was associated with a significantly reduced incidence of microbiologically confirmed VAP.
CLINICAL IMPLICATIONS: Interventions that reduce the incidence of VAP have significant implications for patient outcomes and hospital costs.
DISCLOSURE: Bekele Afessa, No Financial Disclosure Information; Product/procedure/technique that is considered research and is NOT yet approved for any purpose. The silver-coated endotracheal tube (Agento™ I. C., C. R. Bard, Inc.)