Extravasation detection accessory: clinical evaluation in 500 patients

To assess the ability of an extravasation detection accessory (EDA) to detect clinically important (> or = 10 mL) extravascular injection of iodinated contrast material delivered with an automated power injector.

Five hundred patients referred for contrast material-enhanced body computed tomography (CT) participated in a prospective, multi-institutional, observational study in which the EDA was used to identify and interrupt any injection associated with clinically important extravasation. The presence or absence of extravasation was definitively established with helical CT at the injection site (injection rate, from 1.0 to 5.0 mL/sec; mean, 2.9 mL/sec; median, 3.0 mL/sec).

There were four true-positive (extravasation volumes, 13-18 mL), 484 true-negative, 12 false-positive, and no false-negative cases. The prevalence of overall and clinically important (> or = 10 mL) extravasation was 3.6% (18 of 500 cases) and 0.8% (four of 500 cases), respectively. The EDA had a sensitivity of 100% (four of four cases; 95% CI: 51%, 100%) and a specificity of 98% (484 of 496 cases; 95% CI: 96%, 99%) in the detection of clinically important extravasation.

The EDA is easy to use, safe, and accurate in the monitoring of intravenous injections for extravasation, which could prove especially useful in high-flow-rate CT applications.