None listed
Conditions
Brief summary
Every year, approximately 140,000 Peripherally Inserted Central Catheters (PICCs) are inserted in Australia in both children and adults to provide a route of administration for anti-cancer therapies, nutrition and antimicrobials for acute and chronically ill patients. This is despite 30% of PICCs failing prior to completion of treatment due to: deep vein thrombosis (DVT), occlusion, breakage or catheter-associated bloodstream infection (CABSI) including Staphylococcus aureus BSI (SAB). The proposed project will test three different Peripherally Inserted Central Catheter materials (two novel catheters and one standard care) to determine efficacy in preventing PICC complication and failure. The project is to be completed across The Queensland Children’s, Royal Brisbane and Women’s and Princess Alexandra Hospitals. Our investigator group consists of experienced researchers and clinicians from each of these hospitals areas as well as the University of Queensland and Griffith University.
Interventions
At time of PICCs are indicated for insertion (as identified by screening of PICC insertion theatre and medical imaging lists), patients will be randomised to receive either:
Arm 1) Anti-thrombogenic PICC (size decided by clinician due to vascular size and treatment requirements) BioFlo PICC with PASV (by Angiodynamics®)
Arm 2) Anti-microbial (chlorhexidine gluconate [CHG]) PICC (size decided by clinician due to vascular size and treatment requirements) Arrowg+ard Blue Advance PICC (by Teleflex®)
At time of PICCs are indicated for insertion (as identified by screening of PICC insertion theatre and medical imaging lists), patients will be randomised to receive either: Arm 1) Anti-thrombogenic PICC (size decided by clinician due to vascular size and treatment requirements) BioFlo PICC with PASV (by Angiodynamics®) Arm 2) Anti-microbial (chlorhexidine gluconate [CHG]) PICC (size decided by clinician due to vascular size and treatment requirements) Arrowg+ard Blue Advance PICC (by Teleflex®). The allocated PICCs will be provided by the research nurses to the PICC inserter (i.e. physician or nurse; not research staff) immediately prior to PICC inserting procedure. The research nurse will then assess the appropriate PICC has been placed within 24 hours of insertion. The PICCs will remain insitu for the entire treatment duration, as clinically indicated (i.e. the discretion of the clinician). The haematology substudy will evaluate the same intervention products and patients.
Sponsors
NHMRC
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
1 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Require PICC insertion for fluid or medication Informed consent Vascular size sufficient to support 4fr PICC or larger
Exclusion criteria
Previous enrolment in the current study Current catheter-related bloodstream infection Thrombosis in vein where PICC is to be inserted Non-English speaking without an interpreter Known sensitivity to any of the study products including CHG Currently enrolled in conflicting study Added since trial commencement: Admitted for COVID-19, or to a designated COVID-19 unit/facility
Outcome results
None listed