RecruitingACTRN12623000561684

Preventing infusate injuries throughout a child’s hospitalisation

Assessing the impact of an intravenous biosensor on the prevention of infusate injuries throughout a child’s hospitalisation: A Type 1 Hybrid Randomised Controlled Trial


Sponsor

University of Queensland

Enrollment

532 participants

Start Date

Nov 13, 2023

Study Type

Interventional

Conditions

Summary

Many babies and infants admitted to hospital need fluids or medicines delivered directly into their veins using an intravenous (IV) catheter. Over time, IV's can dislodge from the veins and some cases, the medicine or fluid can leak into the child's tissue around the vein, causing damage to the skin, tissue and the vein itself. This is called an extravasation injury. An early sign of extravasation injury is pain, however babies and infants cannot always communicate that the IV site is painful making early detection painful. The IV biosensor is a new device that may help detect extravasation injury sooner. A biosensor is a special light similar to an oxygen saturation probe that is placed on the child's skin above the IV site. It uses near infra-red light to scan the tissues to detect extravasation injury and alerts clinicians so the infusion can be stopped to limit damage caused to the surrounding tissue. This trial will examine whether the IV biosensor helps to detect extravasation injury in babies and infants earlier than compared to standard care. It will also assess whether it is safe and easy to use, and whether it decreases the severity of extravasation injuries.


Eligibility

Sex: Both males and femalesMax Age: 1 Years

Plain Language Summary

Simplified for easier understanding

When babies and young infants are in hospital, they often receive fluids or medicines through a small plastic tube inserted into a vein (an IV). Sometimes this tube can slip out of the vein and the fluid leaks into the surrounding tissue, causing damage — this is called an extravasation injury. Because babies cannot say when the site is hurting, these injuries can go undetected. This trial is testing a new biosensor device that sits on the baby's skin near the IV site and uses a gentle near-infrared light (similar to an oxygen probe) to detect early signs of leakage. Researchers hope the device will alert nurses sooner so they can stop the infusion before serious damage occurs. Your baby may be eligible if they are a newborn weighing at least 1,250 grams or an infant under one year old, they have an IV line in place for at least 24 hours, and are receiving fluids, antibiotics, or other higher-risk medicines. Babies with certain pre-existing skin conditions at the IV site, or who are receiving end-of-life care, would not be eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

The IV biosensor (ivWatch® sensor applied within 10–15mm of the peripheral intravenous catheter (PIVC) tip) plus standard clinical observation to detect extravasations and prevent extravasation injury

The IV biosensor (ivWatch® sensor applied within 10–15mm of the peripheral intravenous catheter (PIVC) tip) plus standard clinical observation to detect extravasations and prevent extravasation injury. The IV biosensor device consists of: 1. A patient monitor with audible alarm, 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 IV biosensor involves the blue sensor being placed over tissue / polyurethane dressing next to the vein between the intravenous (IV) insertion site and the IV tip (normally around 5-10mm from the insertion site) and plugged into the monitor. Once applied, this sensor stays in situ until study end (i.e. IV removal or discharge from study hospital), unless the infant needs magnetic resonance imaging (MRI; due to metal in the sensor) or other treatments which are incompatible with the IV biosensor. The IV biosensor is to be applied on the day of enrolment for both newly inserted PIVCs and existing PIVCs. The IV biosensor 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 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, standard clinical practice) in addition to monitoring the IV biosensor patient monitor. All other aspects of PIVC insertion, management and removal will be standardised in accordance with the hospital site’s clinical practice guidelines. Insertion, maintenance and removal will be performed by the usual interdisciplinary staff. The Clinical Research Nurse will monitor and record adherence to the protocol during a daily check. The IV biosensor 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 the IV biosensor 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.


Locations(3)

Queensland Children's Hospital - South Brisbane

QLD, Australia

Royal Brisbane & Womens Hospital - Herston

QLD, Australia

Sunshine Coast University Hospital - Birtinya

QLD, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12623000561684