How Does Your PICCOMPARE? A Pilot Randomized Controlled Trial Comparing Various PICC Materials in Pediatrics
BACKGROUND: Despite the popularity of peripherally inserted central catheters (PICCs), recent literature highlights their potential injurious complications. Innovative PICC materials have been developed to prevent thrombosis and infection formation (Endexo®) and antireflux valves to prevent occlusion (pressure-activated safety valve®). No large randomized controlled trial has assessed these technologies. Our primary aim was to evaluate the feasibility of a large randomized controlled efficacy trial of PICC materials and design to reduce PICC complication in pediatrics.
METHODS: A randomized controlled feasibility trial was undertaken at the Lady Cilento Children’s Hospital in South Brisbane, Australia, between March 2016 and November 2016. Consecutive recruitment of 150 pediatric participants were randomly assigned to receive either (1) polyurethane PICC with a clamp or (2) BioFlo® PICC (AngioDynamics Inc, Queensbury, NY). Primary outcomes were trial feasibility, including PICC failure (thrombosis, occlusion, infection, breakage, or dislodgement). Secondary outcomes were PICC complications during use.
RESULTS: Protocol feasibility was established, including staff and patient acceptability, timely recruitment, no missing primary outcome data, and 0% attrition. PICC failure was 22% (16 of 74, standard care) and 11% (8 of 72, BioFlo®) corresponding to 12.6 and 7.3 failures per 1000 hours (risk ratio 0.58; 95% confidence interval, 0.21-1.43; P = .172). PICC failures were primarily due to thrombosis (standard care 7% versus BioFlo® 3%) and complete occlusion (standard care 7% versus BioFlo® 1%). No blood stream infections occurred. Significantly fewer patients with BioFlo® had PICC complications during use (15% vs 34%; P = .009).
CONCLUSION: BioFlo® PICCs appear potentially safer for pediatrics than traditional standard care PICCs with a clamp. Further research is required to definitively identify clinical, cost-effective methods to prevent PICC failure and improve reliability.
© 2018 Society of Hospital Medicine
Peripherally inserted central catheters (PICCs) have evolved since their inception in the early 1970s and are used with increasing frequency for pediatric inpatients and outpatients.1-3 Emerging literature, including a meta-analysis of international observational studies,4 reports PICC failure (complications necessitating premature removal) occurs in up to 30% of PICCs, most commonly due to infection, thrombosis, occlusion, and fracture.4-7 Raffini et al.7 report the increasing incidence of pediatric PICC-related thrombosis increases morbidity and mortality8 and negatively impacts future vessel health and preservation.9
PICCs have progressed from relatively simple, silicone-based catheters with an external clamp to chemically engineered polyurethane with pressure-activated valves placed at the proximal or distal catheter hub with the intent to reduce occlusion.10 Further modernization of PICC material occurred with the incorporation of antithrombogenic (AT) material (Endexo®). These PICCs are designed to contain a nonstick polymer, which is designed to reduce the adherence of blood components (platelets and clotting factors) and inhibit thrombus formation (and hence prevent deep vein thrombosis andocclusion, as well as inhibit microbial biofilm attachment [and subsequent infection]).11
In addition to new materials, other aspects of this PICC design have been the addition of a pressure-activated safety valve (PASV®) built into the proximal hub. Pressure-activated valve technology promises to prevent catheter occlusion by reducing blood reflux into the PICC; the valve opens with pressure during infusion and aspiration and remains closed with normal venous pressure, circumventing the need for clinicians to manually clamp the PICC and reducing human error and the potential for thrombosis, occlusion, and fracture development.12 Hoffer et al.13 reported half as many occlusions of valved PICCs (3.3%) compared with nonvalved or clamped PICCs (7.1%); although not statistically significant (P = .10), perhaps due to the small sample, overall complications, including occlusion and infection, were significantly lessened with the valved PICC (35% vs 79%; P = .02). Comparatively, Pittiruti et al.14 conducted a trial of 2 types of valved PICCs with an open-ended, nonvalved PICC and found no reduction in PICC occlusion or catheter malfunction.
Today, PICC use is common for patients who require short-to-medium intravenous therapy. PICCs are increasingly recognized for their significant complications, including thrombosis and infection.15 Novel PICC technology, including the incorporation of AT material such as Endexo® and PASV®, may reduce complications; however, the clinical efficacy, cost-effectiveness, and acceptability of these innovations have not been tested through randomized trials in pediatric patients. In accordance with Medical Research Council guidelines16 for developing interventions, we pilot tested the feasibility of the BioFlo® PICC, including intervention acceptability, compliance, recruitment, and initial estimates of effect, in anticipation of a subsequent full-scale efficacy randomized controlled trial. Our secondary aim was to compare the effectiveness of the BioFlo® PICC with Endexo® and PASV® technology in reducing PICC complications and failure.
METHODS
Design
We undertook a pilot randomized controlled trial comparing the standard polyurethane PICC (with external clamp) with the BioFlo® PICC (with internal valve) in preventing catheter failure in pediatric patients. The study was prospectively registered with the Australian Clinical Trials Registry (ACTRN12615001290583), and the research protocol was published.17
Study Setting
The study commenced in March 2016 at the Lady Cilento Children’s Hospital in South Brisbane, Australia, a tertiary-level, specialist, pediatric teaching hospital in Queensland, Australia, providing full-spectrum health services to children and young people from birth to 18 years of age. Recruitment, including data collection, was completed in November 2016.
Sample
The target sample size was 110 participants, 50 participants per group plus 10% for potential attrition, as determined by standard pilot trial sample size recommendations.18 With ethics approval, the sample size was later increased to 150 participants in order to adequately pilot a microbiological substudy method (published separately).17 Participants were consecutively recruited if they met the inclusion criteria: PICC insertion, age <18 years, predicted hospital stay >24 hours, single-lumen PICC, and written informed consent by an English-speaking, legal parent or guardian. Patients were excluded if they had a current (<48 hours) blood stream infection (BSI), vessel size <2 mm, could not speak English without an interpreter, required a multilumen PICC, or were previously enrolled in the study.
