Peripheral intravenous catheter fixation splint in pediatrics, FIX I/V: A proof-of-concept study protocol

Project Summary Introduction: Using a fixation splint to maintain a peripheral intravenous device (PIVD) is common practice in pediatrics. However, splints are made from small wooden, plastic, or metal boards, and wrapped with gauze and adhesive fabrics. Accidental removals of the PIVD, mechanical complications (infiltrations/extravasations, occlusions, etc.), and skin injuries related to the splint are frequently observed. They do not always keep the PIVD securely in place. In addition, painful procedures to reinstall the PIVD in the child can worsen the negative experience of hospitalization. Moreover, unplanned PIVDs and fixation splint reinstallation appears to increase nurse workload and, consequently, care costs. New PIVD fixation splints for the hand and arm, adapted for newborns, infants, and children, are available in Quebec: the FIX/IV splints. Field observations suggest these splints show promising safety and efficacy. A prospective interventional proof-of-concept study is being conducted. Objective: This article describes the protocol for a prospective interventional proof-of-concept study on the safety and acceptability of the new pediatric FIX/IV PIVD fixation splints. Method: This protocol describes the implementation process conducted in fall 2023 and winter 2024. We selected 30 children for the experimental group and 22 for the control group. We will conduct descriptive and comparative statistics between groups, as well as a questionnaire on the acceptability of these new splints among nurses and parents. Discussion and conclusion: This proof-of-concept protocol presents the expected safety criteria for these new splints, which will improve the rigour and scientific value of future clinical trial phases with a larger sample.