Evaluation of a new safety peripheral IV catheter designed to reduce mucocutaneous blood exposure

摘要

Objectives: We evaluated performance and clinical acceptability of a new peripheral intravenous catheter (PIVC) designed to reduce blood exposure. Methods: A two phased, unblinded, randomized controlled trial was conducted at a clinical research center in New Jersey, USA. In Phase 1, clinicians were asked to evaluate two devices: a PIVC with blood control (BD Insyte Autoguard*BC [Blood Control] Shielded IV Catheter), and a reference conventional PIVC (BD Insyte Autoguard Shielded IV Catheter). In Phase 2, clinicians compared two insertions of the investigational PIVC with blood control (PIVC-BC); one with venous compression and one without. The PIVC-BC was evaluated for superiority to the conventional PIVC with regard to blood exposure and for equivalence in general performance characteristics. Results: Seventy-eight clinicians (mean age: 41.4 years; 89.7% female) and 234 healthy volunteers (mean age: 40.2 years; 61.5% female) were enrolled. Blood leakage occurred significantly more in the conventional PIVC group (39.1%) as compared to the PIVC-BC group (2.0%) (difference: 37.1% [95% CI: 28.8%; 45.15%]). Blood leakage rates for the PIVC-BC with or without use of venous compression were similar, 2.6% and 1.3% respectively (difference: 1.3% [95% CI: -7.8%; 4.7%]). A total of 98.7% of clinicians rated the PIVC-BC as clinically acceptable compared to 89.6% with the reference PIVC (difference: -9.1; 95% CI: -18; -1.5%) and 98.7% agreed it replaced the need for venous compression during catheter insertion (95% CI: 92.8%; 100%). Although the inability to blind clinicians to the investigational product was a potential source of bias, this was unlikely to affect assessments of observed blood leakage. Conclusions: The PIVC with blood control demonstrated reduced blood leakage during insertion and was rated no different for clinical acceptability and insertion performance compared to the conventional PIVC. Clinicians agreed that the new design replaced the need for venous compression to control blood flow during IV catheter insertion.