ivWatch Technology Shows 80% Infiltration Rate in Pediatric Study at Rome’s Gemelli University Polyclinic

Study reveals company’s patented patient monitoring system detects IV infiltrations and extravasations six hours earlier than clinicians

NEWPORT NEWS, Va. — August 9, 2023 A new study conducted by Gemelli University Polyclinic in Rome published in The Journal of Vascular Access (JVA) examines several important metrics that describe the performance of the ivWatch patient monitoring system for the early detection of infiltrations and extravasations in a 16-bed neonatal intensive care unit (NICU). The continuous IV monitoring system was deployed to identify the leakage of non-vesicant intravenous infused fluids in term and preterm infants receiving infusions by the peripheral route (24G short peripheral cannulas).

The study, “Optical detection of infiltration during peripheral intravenous infusion in neonates,” found that continuous infusion site monitoring using the ivWatch system detected an 80% infiltration rate. This infiltration rate is an unfortunate normal in neonatal units, significantly higher than other hospital unit’s infiltration rates. The study found an overall sensitivity of 88.9% in detecting infiltration before the clinician, where the clinician is considered the gold standard. On average, infiltration events were detected six hours prior to a clinical diagnosis.

Neonates are at high risk for unpredictable and unpreventable IV-therapy related complications due to their immature immune systems, fragile skin and blood vessels, and their exposure to additional invasive procedures.1 A delay in diagnosis due to poor surveillance or misinterpretation of clinical signs may carry serious damage to the tissues of the neonate. ivWatch technology uses a predictive algorithm and near-infrared light to see changes in the optical properties of the tissue around an IV site and notifies clinicians to check the IV site if changes are detected in real time.

The ivWatch system has been clinically tested in laboratory and real-world settings, demonstrating high sensitivity and specificity across various patient populations. The system’s continuous monitoring and early detection capabilities have the potential to significantly reduce the severity of IV infiltrations and extravasations, improving patient outcomes and reducing healthcare costs.

The study concluded: “Continuous monitoring of the insertion site, as automatically ensured by this novel optical device, may play a complementary role in early detection of infiltration.”

The study was authored by Vito D’Andrea, Giorgia Prontera,  Riccardo Carlino,  Helena Di Trani, Ilaria Carlettini, Mauro Pittiruti, and Giovanni Vento. The article can be viewed at https://journals.sagepub.com/doi/abs/10.1177/11297298231177723.

To learn more about ivWatch, visit www.ivWatch.com.

1van Rens MFPT, Hugill K, Mahmah MA, et al. Evaluation of unmodifiable and potentially modifiable factors affecting peripheral intravenous device-related complications in neonates: a retrospective observational study. BMJ Open 2021; 11: e047788.

About ivWatch, LLC

ivWatch, LLC  is a biosensor technology company focused on improving patient safety and the effectiveness of intravenous therapy. Our dedicated and passionate team is pioneering the use of optical sensors to detect adverse IV events early to minimize the risk of injury caused by infiltrations and extravasations. By using this technology, clinicians can leverage continuous monitoring to help identify infiltrations as early as possible. Our innovative IV monitoring solutions are backed by decades of clinical research and device development. To learn more, follow us on Twitter @ivWatch, Facebook @ivWatchLLC, Instagram @ivWatchLLC and LinkedIn @ivWatch-LLC, or visit www.ivWatch.com