None listed
Conditions
Brief summary
Peripherally inserted central catheters (PICCs) were developed to provide short to medium term vascular access for patients requiring the infusion of vessel irritant medications, or frequent blood sampling. While PICC’s provide necessary, reliable and accessible vascular access; they are associated with biological, mechanical or infectious complication. These complications result in delayed treatment, need for reinsertion, and delayed treatment of the underlying complication - causing extended admission time, increased healthcare costs, venous depletion and increased morbidity and mortality. Microbial biofilm formation makes treatment of infections more complicated since the detached microbial cells from the biofilm can repeatedly infect the blood, and these microorganisms are highly resistant to many antimicrobial agents, frequently requiring PICC removal and antibiotic treatment. Maintaining catheter function is vital for the safe provision of treatment. BioFlo (trademark) PICC (by Angiondynamics; NY) claims to provide a novel solution and the manufacturers claim the material is resistant to blood products and biofilm development, reducing the risk of standard PICC complications including infection, fracture, thrombosis, leakage, localised swelling, accidental removal and dislodgement . These PICCs are now being used intermittently, on the basis of some clinician preference, at the LCCH, the PAH and elsewhere. The effectiveness of this product at reducing PICC-associated complications as previously described has not been undertaken. At LCCH we plan to undertake a randomized controlled trial. Children or parents and guardians who consent to participate in the trial will be randomly assigned to either study group. The primary aim of this research is to evaluate the feasibility of launching a full-scale efficacy trial, using pre-defined feasibility criteria for recruitment, retention and protocol fidelity. The secondary aim is to compare the effectiveness of this new PICC technology compared to older generation PICC relating to failure and complication due to infection, occlusion, dislodgement, thrombosis, or breakage, for children with PICC in acute care.
Interventions
Patients in this study have peripherally inserted central catheters (PICC) in medical, surgical, anaesthetic and intensive care departments, and only paediatric patients. Consenting parents or legal guardians and patients (if appropriate) will have the type of PICC inserted randomised to either one of the following randomly assigned products
Arm 1: BioFlo polyurethane PICC with endexo technology
Arm 2 (Control): Cook polyurethane PICC
The randomly allocated PICC will be inserted using stan
Patients in this study have peripherally inserted central catheters (PICC) in medical, surgical, anaesthetic and intensive care departments, and only paediatric patients. Consenting parents or legal guardians and patients (if appropriate) will have the type of PICC inserted randomised to either one of the following randomly assigned products Arm 1: BioFlo polyurethane PICC with endexo technology Arm 2 (Control): Cook polyurethane PICC The randomly allocated PICC will be inserted using standard technique for insertion and will remain insitu until completion of therapy, or complication requiring removal. Patients will be followed until device removal, the maximum duration of follow up is 4 weeks.
Sponsors
Griffith University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
*Require PICC insertion for fluid or medication administration; *likely to remain an inpatient for greater than or equal to 24 hours; *able to provide informed consent
Exclusion criteria
*non-tunnelled, tunnelled, dialysis or implanted CVADs or pulmonary artery catheters; *Current bloodstream infection *PICC to be inserted through diseased, burned or scarred skin'; Allergy to study product; and Previous study enrolment in this admission to hospital
Outcome results
None listed