None listed
Conditions
Brief summary
Intravenous (IV) antibiotic therapy is a very common reason for inpatient admissions. Traditionally a short peripheral intravenous cannula (PIVC) (<4 cms) has been the ‘default’ device for short term (1-14 days) antibiotic therapy however 33 – 54% of short-PIVCs fail during treatment, resulting in delayed antibiotic administration and repetitive insertion procedures. Interruption to antibiotic treatment has been linked to re-emergence of infectious disease, increased hospital stays, and antimicrobial resistant organisms. Recently, longer peripheral IV devices (4.5 -6.4 cms) have been introduced for short-term peripherally-compatible IV therapy. While observational data appears to suggest that long-PIVCs (with a greater catheter length within the vein) out-perform short-PIVCs, this has not been evaluated in a randomised controlled trial (RCT). We will conduct a single centre, two-arm, parallel RCT whereby initially 70 patients will be randomised to receive either a short-PIVC (control) or long-PIVC (intervention) for antibiotic administration. Should feasibility criteria be met a total 192 will be randomised to a fully powered study. We the investigators hypothesise that long-PIVCs will result in less antibiotic therapy interruption, with patients requiring fewer subsequent PIVC insertions.
Interventions
Intervention arm:
a long-PIVC, i.e. Introcan Safety® Deep Access (B Braun) or BD Insyte™ Autoguard™ BC (long: 4.5-6.4cms length).
Device type, size/gauge and vein selection will be decided by the ReN on assessment of the patient's vascular access. All PIVCs will be inserted, maintained and removed as per hospital policy. All insertions will be performed by a Research Nurse (ReN) experienced in PIVC insertion. PIVCs will be maintained by clinical staff and the decision to remove the PIVC will
Intervention arm: a long-PIVC, i.e. Introcan Safety® Deep Access (B Braun) or BD Insyte™ Autoguard™ BC (long: 4.5-6.4cms length). Device type, size/gauge and vein selection will be decided by the ReN on assessment of the patient's vascular access. All PIVCs will be inserted, maintained and removed as per hospital policy. All insertions will be performed by a Research Nurse (ReN) experienced in PIVC insertion. PIVCs will be maintained by clinical staff and the decision to remove the PIVC will be made by the treating team. Protocol violations will be participants not receiving the randomised intervention on PIVC insertion. Protocol adherence will be managed by the ReN who will be responsible for insertion of all study devices and will be described descriptively as per the primary outcomes. Extensive education sessions and written materials will be provided to staff to enhance protocol adherence. The trial will be conducted in two phases: Phase One – Pilot Trial Protocol safety and feasibility will be assessed in a pilot RCT of 70 participants. After 70 patients have been recruited, feasibility outcomes and protocol safety will be assessed. If the interim analysis finds feasibility outcomes are being met and there are no safety issues identified with the protocol, the study will move on to Phase Two. If feasibility outcomes are not being met or safety issues are identified at this point, the study will cease. Phase Two – Powered RCT The study will continue recruitment to the final powered sample size calculated as 192 patients (power 0.8) (this will be re-calculated following the interim analysis and adjusted as required). We will recruit participants over a total of 26 weeks for both phases.
Sponsors
Royal Brisbane and Women's Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• 18 years or older • Requiring peripherally-compatible IV antibiotic treatment for equal to or greater than 3 days • ability to provide informed written consent
Exclusion criteria
• Patients with upper arm limitations (e.g. mastectomy, renal patients) • Non-English-speaking patients without interpreter • Patient receiving end-of-life care • Previous enrolment in the study
Outcome results
None listed