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

Area of Science:

• Medical Devices
• Pediatric Care
• Clinical Trials

Background:

• Peripheral intravenous catheters (PIVCs) are essential for hospitalized children, but up to 45% fail, and 20% cause injuries like infiltration or extravasation.
• Biosensor technology offers a potential solution to detect early signs of catheter dysfunction and prevent associated injuries.

Purpose of the Study:

• To evaluate the effectiveness and implementation of an IV biosensor in preventing infiltration/extravasation injuries in hospitalized neonates and infants.
• To assess secondary outcomes including injury severity, treatment sequelae, quality of life, and cost-effectiveness.
• To explore barriers and facilitators for future implementation of IV biosensor technology.

Main Methods:

• A multi-site, type 1 hybrid effectiveness-implementation randomized controlled trial involving 532 neonates and infants up to 1 year of age.
• Participants randomized 1:1 to standard observation plus IV biosensor or standard observation alone.
• Primary outcome: infiltration/extravasation injury occurrence measured by the Extravasation Harm Scale; secondary outcomes assessed via mixed methods.

Main Results:

• The study is designed to determine if IV biosensors reduce infiltration/extravasation injuries in infants.
• Data on injury occurrence, severity, quality of life, and cost-effectiveness will be collected.
• Implementation context will be explored through ecological momentary assessments and interviews.

Conclusions:

• The PATCH trial addresses a critical evidence gap for IV biosensor technology in vulnerable infant populations.
• This hybrid study will yield comprehensive data on effectiveness and implementation strategies.
• Findings will inform clinical practice and guide future adoption of IV biosensors to prevent extravasation injuries.