A study published this month in The BMJ (British Medical Journal) analyzed the use of optical sensor technology from ivWatch, the U.S.-based IV safety company, in the early detection of peripheral intravenous infiltration or extravasation (PIVIE) events in neonates. Presenting a comparative evaluation between conventional observational methods and continuous sensor-based monitoring, the study offers insights into how ivWatch can be integrated into neonatal intensive care units (NICUs) to significantly reduce IV injuries in a particularly vulnerable patient population.
Authored by Roland van Rens, a neonatal vascular access expert and former Clinical Director of Nursing at the HMC Women’s Wellness and Research Center, the study was conducted over a four-year period, from January 1, 2019, to December 31, 2022, in the NICU in Doha, Qatar. In the first period of the study (2019–2020), Peripheral Intravenous Infiltration and Extravasation (PIVIE) detection relied solely on periodic ‘Touch Look Compare’ (TLC) assessments, while in the second period (2021–2022), continuous monitoring using the ivWatch system was implemented alongside TLC assessments.
The severity of IV infiltration injuries was assessed using the Intravenous Extravasation Grading Scale (IEGS), developed by Cincinnati Children’s Hospital. This tool estimates the percentage of tissue area affected by infiltration or extravasation. Although the overall number of PIVIE events remained stable across both phases, injuries were far less extensive when ivWatch was used. The number of events with more than 30% estimated tissue involvement dropped from 243 cases to 54 cases. Events affecting more than 15% of the surrounding tissue fell from 2,613 cases to just 180 cases— a respective decrease of 78% and 93%.
Conventional methods of identifying infiltrations allow injuries to go unnoticed, develop silently, and are often not reported or frequently misdiagnosed. This silent threat in IV therapy can create serious harm to patients, including skin necrosis, scarring and staining, nerve damage, medication dosing errors, and in extreme cases, amputation.
According to van Rens, “By identifying infiltration events at a much earlier stage, healthcare providers can intervene sooner and thereby reduce patient harm. The ability to detect PIVIEs early before they lead to severe harm could significantly improve patient outcomes and help raise the standard of care in neonatal vascular access.”
Van Rens continued, “The increased detection of PIVIE events highlights the ivWatch system’s sensitivity — including its ability to identify even small volumes of fluid leakage. Earlier alerts give healthcare providers the opportunity to act before an infiltration progresses. In our study, combining ivWatch with standard TLC assessments was associated with a clear drop in severity: the median estimated tissue involvement decreased from 15% to 5%, and the number of severe events affecting more than 30% of tissue dropped by more than three-quarters. This reduction in injury severity is a novel and promising step forward in neonatal vascular access care.”
The article notes that the mean catheter dwell time decreased from 35:35 hours to 32:23 hours (p<0.001), suggesting that infiltrations may have been detected and addressed earlier, thereby minimizing the severity of tissue damage.
“It is important to address the sensitivity and specificity of the ivWatch system, as these are key indicators of the device’s effectiveness. Previous studies, including a pilot evaluation in a neonatal population, reported that the ivWatch system demonstrated a sensitivity of 93.3% for detecting infiltration events, with all detections occurring before clinical identification by staff. A more recent study further confirmed the system’s performance, achieving a sensitivity of 100% in detecting PIVIEs before clinician confirmation. These findings suggest that the ivWatch system is highly reliable in identifying early-stage infiltrations, which likely accounts for the increase in detected PIVIE events in our study. The device’s ability to provide earlier notification of potential PIVIEs contributes to its efficacy in reducing the severity of these events.”
ivWatch technology uses a predictive algorithm and visible and near-infrared light to detect changes in the optical properties of the tissue around an IV site. It notifies clinicians to check the IV site if changes are detected in real time. The ivWatch system has been clinically tested and proven in laboratory and real-world settings, demonstrating high sensitivity and specificity across various patient populations and clinical settings. The system’s continuous monitoring and early detection capabilities have the potential to significantly reduce the severity of IV infiltration and extravasation injuries, advance clinical competency, improve patient outcomes, and reduce healthcare costs and liability.
Learn more here.