Introduction: Peripheral intravenous catheters (PVCs) are essential for the administration of intravenous fluids and medications. Successful PVC insertion and prevention of resultant catheter-related complications are important clinical objectives and patient outcomes. Compared to generalist inserters, PVCs inserted by vascular access specialists (VAS) are believed to preserve veins, improve the experience for patients, decrease infusion complications and reduce costs associated with clinician time, materials and length of hospital stay. However, there is a lack of robust randomised controlled trials (RCT) that have tested skill level on successful PVC insertion and prevention of PVC failure.

Methods and analysis: This is a single-centre, parallel group, pilot RCT. It will compare the effectiveness of PVC insertion by a VAS with insertion by any nursing or medical clinician (generalist model) on clinical and economic outcomes. This trial will be conducted at the Royal Brisbane and Women’s Hospital, Australia, and recruit 50 participants per group (n=100). The primary outcome is to test the feasibility of conducting an adequately powered RCT as established by predetermined criteria for eligibility, recruitment, retention and attrition, protocol adherence, missing data, effect size (for number of insertion attempts and PVC failure) and patient satisfaction. PVC failure is defined as device removal associated with: phlebitis, infiltration, occlusion, accidental removal, local infection or catheter-related bloodstream infection. Feasibility outcomes will be reported descriptively and analysed against predetermined acceptability criteria. As a pilot study, statistical comparison methods will be tested, but statistical differences are not expected to be observed. 

Ethics and trial commencement: This pilot trial has ethical approval from Queensland Health (HREC/16/QRBW/386) and Griffith University (2016/782). 

Trial registration: ACTRN12616001675415.

Keywords: Intravenous, vascular access devices, randomised controlled trial, phlebitis.

Background: The importance of decontaminating needleless connectors prior to accessing central venous access devices (CVADs) to prevent CVAD-associated bloodstream infection has been highlighted. However, the optimal decontamination time and solution is still under-evaluated. 

Aim: This study will compare different decontamination methods of CVAD needleless connectors in adult patients. The aims of this pilot trial are: to assess recruitment feasibility, data collection strategies and proposed methods; and to test the interventions with the control to determine an adequate sample size for a future, larger clinical trial.

Design: A single-centre, parallel, pilot randomised control trial (RCT) with a superiority design.

Methods: There will be three arms: 70% isopropyl alcohol swab (control); 2.0% chlorhexidine gluconate in 70% isopropyl alcohol swab; and a 70% isopropyl alcohol-impregnated cap. The primary outcome of this pilot trial is to assess feasibility for a future, larger clinical trial. The secondary outcome is CVAD-associated bloodstream infection. In total, 120 patients will be recruited over six months with a four-week follow-up. Prospective patients who are scheduled to have a CVAD inserted will be eligible. Randomisation will be computer-generated, central and concealed until allocation. Due to the nature of the interventions it will not be possible to blind clinicians or patients.

Discussion: Preventing CVAD-associated bloodstream infection in hospitalised patients is vital. Interventional decontamination techniques that demonstrate superior performance in preventing CVAD-associated bloodstream infection would improve patient outcomes, reduce patient morbidity and mortality, and health care-associated costs.

Trial Registration: ACTRN12615001120561.

Keywords: Bloodstream infection, CABSI, central venous access device, CVAD, needleless connectors, nursing.