Integrated versus nonintegrated peripheral intravenous catheter in hospitalized adults (OPTIMUM): A randomized controlled trial

BACKGROUND: One‐third of peripheral intravenous catheters (PIVCs) fail from inflammatory or infectious complications, causing substantial treatment interruption and replacement procedures. OBJECTIVES: We aimed to compare complications between integrated PIVCs (inbuilt extension sets, wings, and flattened bases) and traditional nonintegrated PIVCs. DESIGNS, SETTINGS AND PARTICIPANTS: A centrally randomized, controlled, superiority trial (with allocation concealment until study entry) was conducted in three Australian hospitals. Medical–surgical patients (one PIVC each) requiring intravenous therapy for >24 h were studied. MAIN OUTCOME MEASURES: The primary outcome was device failure (composite: occlusion, infiltration, phlebitis, dislodgement, local, or bloodstream infection). Infection endpoints were assessor‐masked. The secondary outcomes were: failure type, first‐time insertion success, tip colonization, insertion pain, dwell time, mortality, costs, health‐related quality of life, clinician, and patient satisfaction. RESULTS: Out of 1759 patients randomized (integrated PIVC, n = 881; nonintegrated PIVC, n = 878), 1710 (97%) received a PIVC and were in the modified intention‐to‐treat analysis (2269 PIVC‐days integrated; 2073 PIVC‐days nonintegrated). Device failure incidence was 35% (145 per 1000 device‐days) nonintegrated, and 33% (124 per 1000 device‐days) integrated PIVCs. INTERVENTION: Integrated PIVCs had a significantly lower failure risk (adjusted [sex, infection, setting, site, gauge] hazard ratio [HR]: 0.82 [95% confidence interval, CI: 0.69–0.96], p = .015). The per‐protocol analysis was consistent (adjusted HR: 0.80 [95% CI: 0.68–0.95], p = .010). Integrated PIVCs had significantly longer dwell (top quartile ≥ 95 vs. ≥84 h). Mean per‐patient costs were not statistically different. CONCLUSIONS: PIVC failure is common and complex. Significant risk factors include sex, infection at baseline, care setting, insertion site, catheter gauge, and catheter type. Integrated PIVCs can significantly reduce the burden of PIVC failure on patients and the health system.