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.