Preventing InfusAte injuries throughout a Child's Hospitalization (PATCH): Study protocol for a type 1 hybrid randomized controlled trial

Abstract

INTRODUCTION: Peripheral intravenous catheters (PIVCs) are a vital part of care for hospitalized children. Despite commonality, up to 45% fail before treatment completion, with up to 20% of PIVCs resulting in an infusate-associated injury, such as infiltration or extravasation. Biosensors developed to detect preclinical signs of intravenous catheter dysfunction have the potential to prevent significant injuries. METHODS: This multi-site, type 1 hybrid effectiveness-implementation randomized controlled trial will evaluate an IV biosensor for preventing infiltration/extravasation injuries in hospitalized neonates and infants. Participants up to 1 year of age who require a PIVC with continuous or moderate-high risk infusates will be recruited from three Australian hospitals. Participants (n = 532) will be randomized 1:1 to receive either standard observation plus IV biosensor or standard observation alone. The primary outcome is infiltration/extravasation injury occurrence, measured using the Cincinnati Children's Hospital Medical Centre Extravasation Harm Scale by the masked outcome assessment committee. Secondary outcomes include infiltration/extravasation severity, volume, treatment sequelae, quality of life, and cost-effectiveness. The implementation context exploration will use mixed methods, including ecological momentary assessments and semi-structured interviews, to evaluate barriers and facilitators for future implementation. DISCUSSION: The PATCH trial addresses a significant gap in evidence regarding the effectiveness and implementation of IV biosensor technology in preventing extravasation injuries in vulnerable infant and neonatal populations. The hybrid effectiveness-implementation study will provide comprehensive data to inform both clinical practice and future implementation strategies. TRIAL REGISTRATION: ACTRN12623000561684.