Comparing ivWatch biosensor to standard care to identify extravasation injuries in the paediatric intensive care: a protocol for a randomised controlled trial

Abstract

IntroductionPeripheral intravenous catheters (PIVCs) frequently fail during therapy administration, resulting in infusates pooling in the surrounding tissue. These extravasation injuries can cause significant pain, tissue destruction and scarring. ivWatch is a biosensor that uses visible and near-infrared light to measure tissue changes surrounding the PIVC and alert clinicians when extravasation may occur. The effectiveness of ivWatch, in comparison to clinical observation, in decreasing injury severity is unknown. The present study aims to investigate whether using ivWatch may potentially detect injury earlier and decrease the severity of PIVC extravasation injuries.Methods and analysisA single centre, parallel group, open-label superiority randomised controlled trial comparing (a) standard care (clinical observation) to (b) ivWatch monitoring in addition to standard care, to decrease the severity of extravasation injuries. 200 children with PIVCs inserted in the distal half of the limb, receiving intermediate-risk to high-risk infusates for ≥24 hours, will be consecutively recruited at a paediatric intensive care unit in Queensland, Australia. The primary outcome is extravasation severity, measured by the Cincinnati Children’s Extravasation Harm Scale. Secondary outcomes include severity assessed with three-dimensional camera imaging, extravasation volume, treatment sequelae, the number of PIVCs used and dwell time, quality of life and healthcare costs. The between treatment difference in extravasation severity will be compared using ordinal logistic regression, with the treatment group included as the main effect, and reported with corresponding 95% CIs. Estimates of value will be presented as net monetary benefits and cost per reduction in extravasation injury severity, both presented with corresponding 95% credible intervals.Ethics and disseminationThis study received approval from the Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee (HREC) (reference number: HREC/20/QCHQ/60867) and the Griffith University HREC (reference number: 2020/310) and will be disseminated via peer-reviewed publications and conference presentations.Trial registration numberACTRN12620000317998.

Midline Compared With Peripheral Intravenous Catheters for Therapy of 4 Days or Longer in Pediatric Patients

“…15 These are characterized by pain, erythema, and swelling as infusates enter the subcutaneous tissue and are clinically important complications that can severely impact lifelong function across affected joints and muscles groups. 40 We also found infiltration to be the most common complication, and this occurred more frequently in The exact mechanism of this reduction in infiltration is unclear; however, as described in a pediatric RCT comparing long vs short PIVCs, it is possible that the shorter-length PIVC migrates outside the vein wall, particularly if inserted in an area of flexion, or venous erosion occurs due to chemical irritation of the infusate. 17 We saw no cases of phlebitis in the MC group.…”

“…According to a 2021 meta-analysis, infiltration and extravasation injuries are the most common modes of PIVC failure in hospitalized pediatrics (10% pooled incidence [95% CI, 0.07-0.14]) . These are characterized by pain, erythema, and swelling as infusates enter the subcutaneous tissue and are clinically important complications that can severely impact lifelong function across affected joints and muscles groups . We also found infiltration to be the most common complication, and this occurred more frequently in PIVCs (13 of 65 [20.0%]) than MCs (1 of 62 [1.6%]; P = .01).…”

Sensing Technologies for Extravasation Detection: A Review

“…In recent years, the demand for biosensors has grown, 56 showing potential use also in extravasation detection. 75 Single sensor refers to a device targeting a single specific biophysical information to to be measured. In the following sections, sensors based on bioimpedance, ultrasonic image, radiofrequency transmission, ultrasound, fluid pressure, and skin strain are presented.…”

“…In recent years, the demand for biosensors has grown, showing potential use also in extravasation detection . Single sensor refers to a device targeting a single specific biophysical information to to be measured.…”