A new device to limit extravasation during contrast-enhanced CT

Area of Science:

• Radiology and Imaging Technology
• Medical Device Innovation
• Patient Safety in Interventional Procedures

Background:

• Contrast extravasation during CT scans poses a risk of patient injury.
• Power injectors deliver contrast media rapidly, increasing extravasation potential.
• Existing methods for detecting extravasation are limited.

Purpose of the Study:

• To evaluate the sensitivity and reliability of the Extravasation Detection Accessory (EDA) in a simulated contrast extravasation model.
• To determine the effectiveness of the EDA in halting power injector function during extravasation.
• To assess the potential of the EDA to minimize contrast volume delivered during extravasation events.

Main Methods:

• An EDA device was tested on subjects with simulated extravasation using nonionic and ionic contrast equivalents.
• Infusions were conducted at varying rates: 0.25 ml/sec, 2.5 ml/sec, and 5 ml/sec.
• The EDA's ability to detect extravasation and halt the power injector was recorded.

Main Results:

• The EDA successfully halted the injector in all tested subjects at 2.5 ml/sec and 5 ml/sec infusion rates.
• At 0.25 ml/sec, the EDA initially failed in 11 of 20 events but, after algorithm reprogramming, halted 18 of 20 events.
• The average delivered volume before halting was significantly reduced after algorithm adjustment at the lowest rate.

Conclusions:

• The Extravasation Detection Accessory demonstrates reliable and reproducible performance in halting power injectors during simulated contrast extravasation.
• The device shows promise in reducing the volume of contrast material delivered during extravasation, potentially minimizing patient morbidity.
• Further refinement may be needed to achieve 100% sensitivity across all injection rates.