Venous access is the most commonly performed invasive medical procedure with over 330 million peripherally inserted venous catheters (PIVC) used annually in the US and 1.2 billion globally. However, the rate of failure prior to completion of therapy remains unacceptably high in pediatric patients, with a reported 95% citing complications and removal within 30 hours of placement. The high rate of PIVC failure in pediatric patients is primarily attributable to overpenetration through the back wall of the vein resulting in infiltration into the perivascular space in 70% of cases. The low 23% first-attempt success rate with repeated failed access eventual requires conversion to intraosseous or central line placement, particularly in emergency or neonatal patients. Notwithstanding the stress, trauma and long-term psychological impairment towards receiving future medical treatment, resulting phlebitis (local pain, redness, blood infiltration, swelling) from a failed first attempt causes a ~5-fold greater chance of failure in subsequent local catheter placements. Attempts to reduce the incidence of overpenetration has led to the implementation of specialized IV teams which emphasizes the need for improved PIVC placement as well as dependence on operator skill level. The current proposal seeks to address these limitations by establishing the feasibility of a novel pediatric PIVC (PPIVC) to provide first-attempt, single wall venous access in pediatric patients regardless of operator skill level or ability to visualize the vein. The TrueCath system facilitates PPIVC placement by incorporating a mild vacuum in the flashback chamber, which upon entering the vein and sensing the change in pressure, safely and quickly deploys the soft gel IV catheter forward, via a simple spring mechanism. The Truecath sensor can easily be incorporated into current PPIVC devices at equivalent cost. Importantly, the catheter portion is deployed quickly enough to prevent overpenetration that would otherwise occur due to the delay in blood entering the flashback chamber, which usually serves as both the index of access and major limitation of current PPIVCs. Initial bench and in vivo studies of an adult variant have demonstrated the ability of the TrueCath system to sustain vacuum and release the catheter portion at the appropriate force and speed to provide a 98% first-attempt success rate in vivo. The current proposal will translate these excellent results into a pediatric version which has unique design challenges of catheter size and deployment force in order to accommodate smaller, more fragile veins and tissues in pediatric patients. Performance of the device will be characterized first on bench (Aim 1) followed by in vivo assessment for reductions in overpenetration and number of attempts (Aim 2). Successful execution of these Phase I studies will appropriately position the TrueCath system for full development and regulatory approval (future Phase II) of a novel and highly innovative approach to resolve PIVC complications and improve the standard of pediatric patient care.
Public Health Relevance Statement: NARRATIVE Approximately 80% of pediatric peripheral IV catheters fail during first attempt at insertion, with the vast majority due to needle overpenetration and infiltration. The overall objective of this proposal is to validate the safety and efficacy of a novel pediatric peripheral IV catheter system to reliably provide first-attempt, single wall venous access to reduce patient discomfort, venous depletion, catheter failure and healthcare cost.
Project Terms: Address; Adipose tissue; Adoption; Adult; Animals; Back; Blood; Blood Vessels; Cannulations; Caregivers; Caring; Catheters; Childhood; Clinical; cost; Dependence; design; Development; Devices; Emergency medical service; Emergency Situation; Environment; Excision; Extravasation; Failure; Frequencies; Future; Gel; Hand; Health Care Costs; Healthcare; Hospitals; Hour; Hydration status; Imagery; Impairment; improved; in vivo; Incidence; indexing; Infection; Infiltration; Infusion procedures; innovation; Institutes; Intravenous; Life; Location; Medical; Military Personnel; National Institute of Child Health and Human Development; Needles; neonatal patient; neonate; novel; Nursing Staff; operation; Pain; Patient Care; patient population; Patients; pediatric patients; Performance; Peripheral; Pharmaceutical Preparations; Phase; phase 1 study; Phlebitis; Population; Positioning Attribute; pressure; prevent; Procedures; psychologic; Reaction Time; Redness; Reporting; Resources; Risk; Safety; Savings; sensor; Services; skills; Specialist; Speed; Stress; subcutaneous; success; Support System; Swelling; System; Techniques; Technology; Testing; Thick; Time; TimeLine; Tissues; tool; Training; Training Programs; Transillumination; Translating; Trauma; Ultrasonography; United States; United States National Institutes of Health; Vacuum; Validation; Variant; Veins; Venous; Venous system
