Early detection of extravasation injuries in children with critical illness

Brief name: ivWatch® One hundred patients admitted to a Paediatric Intensive Care Unit (PICU) with a peripheral intravenous access device (PIVC) receiving intermediate to high risk infusates and randomised to the ivWatch intervention arm will be provided with the ivWatch® device. The ivWatch® device consists of a sensor ~2 cm in diameter that is attached to the patient’s skin with an adhesive receptacle as close as possible to the centre of the PIVC site (approximately 1 cm), and covered with gauze. The sensor connects to the ivWatch® monitor via a cable. The ivWatch® device will be applied by member of the research team (a Clinical Research Nurse), and monitored hourly by the patient’s bedside nurse throughout the course of their PICU admission or until their PIVC is removed. The patient’s bedside nurse will also continue to monitor the PIVC site hourly for signs of extravasation (per usual, routine clinical practice) in addition to monitoring the ivWatch® patient monitor. All other aspects of PIVC insertion, management and removal will be standardised in accordance with QCH clinical practice guidelines. Insertion, maintenance and removal will be performed by the usual PICU interdisciplinary staff. The ivWatch® device consists of: 1. A patient monitor, 2. An optical sensor cable, and, 3. A sterile, disposable receptacle for attaching the sensor to the patient’s skin, near the PIVC site The ivWatch® uses near infra-red light to continuously monitor the fluid pathway and surrounding tissue for early signs of extravasation. When fluid accumulates in the subcutaneous tissues, there is a significant change in the light scattering, which is recognised by ivWatch® sensor and results in a “YELLOW CHECK IV” notification on the patient monitor, indicating the possibility of extravasation. If the infusion continues and the light signal further drops below the threshold, the patient monitor will return a “RED CHECK IV” notification, indicating probable extravasation. According to the ivWatch® manufacturers, the algorithm used to process the light signal from the sensor is designed to maximize sensitivity and specificity for infiltration events, while minimizing the number of false alarms from other events (e.g., patient movement).