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Biosensor Compared With Standard Care to Identify Extravasation Injuries in Paediatric Intensive Care: A Randomised
Craig A McBride1,2,3,4, Sarfaraz Rahiman5, Melanie Kennedy5
1Surgical Team: Infants, Toddlers, Children (STITCh), Queensland Children's Hospital, South Brisbane, Queensland, Australia.
Insights
A biosensor monitoring system did not significantly reduce extravasation injuries in children receiving high-risk intravenous medications in paediatric intensive care units (PICU). The tissue-infiltration biosensor technology was found to be acceptable for use by nursing staff.
Area of Science:
- Pediatric Intensive Care
- Medical Device Technology
- Patient Safety
Background:
- Peripheral venous access devices (PVADs) are crucial in pediatric intensive care units (PICUs).
- Extravasation injuries, a risk with PVADs, can lead to significant harm.
- Monitoring technology aims to improve early detection and prevention of these injuries.
Purpose of the Study:
- To assess if a tissue-infiltration biosensor (ivWatch) reduces extravasation injuries in pediatric patients receiving intermediate- or high-risk medications via PVADs.
- To compare the efficacy of biosensor monitoring plus standard care against standard care alone in preventing extravasation harm.
- To evaluate the usability and acceptance of the biosensor technology by nursing staff.
Main Methods:
- A randomized controlled trial was conducted in a single quaternary hospital PICU.
- 175 children with PVADs receiving high-risk infusates were randomized to either biosensor monitoring or standard care.
- The primary outcome was extravasation severity, measured using the Cincinnati Children's Hospital Medical Centre Extravasation Harm Scale.
Main Results:
- No statistically significant difference in extravasation severity was found between the biosensor group (n=88) and the standard care group (n=87).
- Injury rates (no, mild, moderate) were comparable across both groups.
- No significant differences were observed in extravasation volume, treatment sequelae, or device dwell time.
Conclusions:
- Biosensor monitoring, when added to standard care, did not significantly decrease extravasation injuries in this PICU population.
- The ivWatch biosensor system demonstrated acceptability among bedside nursing staff.
- Further research may be needed to explore the role of biosensors in pediatric patient safety.
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.
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