Tricia Kleidon, Amanda Ullman, Sarah Northfield, Li Zhang, Gabor Mihala, Nicole Gavin, Claire M Rickard
Introduction: Peripherally inserted central catheters (PICC) are integral to the treatment of acute and chronic illness. Yet premature device failure occurs in approximately 30% of cases, causing interruptions to treatment that can be life-threatening. PICCs manufactured with specific compounds (such as Endexo™ technology) claim to prevent thrombosis (blood clots) and infections by reducing microbial and blood product attachment. To date, no large randomised controlled trial (RCT) has sufficiently assessed the impact of this technology on reducing PICC complication and failure.
Methods and analysis: This is a multi-centre parallel group, pragmatic pilot study to assess the feasibility of a definitive RCT comparing the effectiveness of the BioFlo™ with Endexo™ technology PICC in a tertiary paediatric and adult facility. The pilot study commenced in January 2016 at the Lady Cilento Children’s Hospital, Brisbane, Australia; and is soon to commence at the Royal Brisbane and Women’s Hospital, Brisbane, Australia. Recruitment and random allocation of 220 participants will occur over two years, allowing for a staggered start between both pilot sites. Primary outcomes will be study feasibility, measured by eligibility, recruitment, retention, attrition, missing data, cost, parent/patient/staff satisfaction, and effect size. PICC failure and complication (thrombosis, occlusion, catheter-associated bloodstream infection, local infection, dislodgement and fracture) will be compared between intervention and control groups. Relative incidence rates of PICC failure per 100 devices and per 1,000 PICC days (with 95% confidence intervals) in each trial arm will summarise treatment impact. Kaplan-Meier survival curves will compare failure rates over time.
Ethics and dissemination: Ethical approval was gained from Queensland Health (HREC/15/QRCH/164) and Griffith University (2016/077). Results will be published according to the CONSORT statement.
Trial registration: ACTRN12615001290583 and ACTRN12616001578493.
Keywords: Catheterisation, central venous; peripherally inserted central catheters; vascular access devices, central venous catheters; PICC; upper extremity deep vein thrombosis.