Accuracy of Four Intravenous Infusion Devices in a Clinical Setting: A Randomized Controlled Trial

Accurate delivery of intravenous fluids is essential for patient safety, but the flow rate accuracy of different infusion devices in clinical settings remains incompletely characterized. This study aims to compare the flow rate accuracy of four intravenous infusion devices-Terufusion TE-112, Volumed μVP7000, Auto Clamp, and Infucon-across multiple flow rates in patients undergoing elective surgery under general anesthesia.

In this single-center, randomized controlled trial, 80 adult patients (ASA physical status 1–2) scheduled for elective surgery of more than 2 hours were randomized to one of four infusion device groups (n = 20 per group). Each device delivered 0.9% normal saline at set flow rates of 10, 50, 100, and 200 mL/h for 30 minutes each. Delivered volumes were calculated by gravimetric measurement using a calibrated electronic balance. Accuracy was expressed as delivered/set flow rate (%). Between-group differences were analyzed using a Linear Mixed-Effects Model (LMEM) and Wilks' lambda MANOVA.

LMEM revealed a significant between-group difference (F[3,313] = 5.690, P = 0.001). Infucon consistently over-delivered compared with all other devices (MANOVA: F(12,193.43) = 11.983, p < 0.001; λ = 0.230). Mean overall accuracies were: Terufusion TE-112, 96.72 ± 0.98%; Volumed μVP7000, 96.35 ± 1.34%; Auto Clamp, 100.19 ± 0.88%; and Infucon, 110.31 ± 1.88%. Infucon exceeded ±10% error at 10 mL/h (+17.25%) and 50 mL/h (+10.16%). Bland–Altman overall limits of agreement were ±1.92, ±2.62, ±1.72, and ±3.68 mL, respectively.

Three intravenous infusion devices accurately administered drugs within ±10% of the set flow rate under all test conditions. The gravity flow controller (Infucon) was consistently overdosed, reaching an average accuracy of 110.31%, particularly at low flow rates, with clinically meaningful implications for fluid and drug management.

Three of the four tested infusion devices demonstrated clinically acceptable flow-rate accuracy across all tested conditions. The gravity-type flow regulator (Infucon) showed significant over-infusion.