Biosensor Compared With Standard Care to Identify Extravasation Injuries in Paediatric Intensive Care: A Randomised Controlled Trial

Aim: To evaluate whether, in children treated in paediatric intensive care units (PICU) with peripheral venous access devices (PVADs) receiving intermediate‐ or high‐risk peripheral intravenous medications, the use of a tissue‐infiltration biosensor (ivWatch), compared to standard care, reduces extravasation injuries. Methods: A superiority, parallel group randomised controlled trial conducted in a single Queensland quaternary hospital PICU from September 2020 to July 2022. Children with PVADs inserted in the distal half of the limb and receiving intermediate‐ to high‐risk infusates for ≥ 24 h were randomly allocated in a 1:1 ratio to biosensor (ivWatch monitor applied within 10–15 mm of the PVAD tip) plus standard clinical observation, or standard observation alone. Primary outcome was extravasation severity on the 4‐point Cincinnati Children's Hospital Medical Centre Extravasation Harm Scale. Injuries were compared between treatment groups using ordinal logistic regression. Results: A total of 175 children were enrolled, 88 to biosensor and 87 to standard care. Extravasation severity was similar between groups, with no, mild and moderate injury occurring in 56 (69%), 25 (30%) and 2 (2%) participants in the biosensor group and 61 (70%), 24 (28%) and 2 (2%) in the standard care group (proportional odds ratio = 1.13; 95% CI: 0.59, 2.15, p = 0.71). No statistically significant between‐group differences in extravasation severity, volume, treatment sequelae, PVADs used or dwell time were observed. The biosensor was acceptable to nurses. Conclusions: In this PICU population, biosensor monitoring in addition to standard care did not significantly reduce extravasation injuries. The technology was acceptable to bedside nursing staff. Trial Registration: ACTRN12620000317998