Using a LOng peripheral intraVEnous catheter with retractable guidewire to optimize first-insertion success for patients with Difficult IntraVenous Access in the emergency department (LOVE-DIVA): a study protocol for a randomized controlled trial.

ABSTRACT

INTRODUCTION: First-insertion success rates for peripheral vascular access devices (PVADs) in patients with difficult venous access (DIVA) are low, which negatively affects staff workload, patient experience, and organizational cost. There is mixed evidence regarding the impact of a peripheral vascular access device with retractable coiled tip guidewire (GW; AccuCath™, BD) on the first-insertion success rate. The aim of this study is to investigate whether the use of long GW-PVADs, compared with standard PVADs, reduces the risk of first-time insertion failure, in patients admitted to emergency departments (EDs). METHODS AND ANALYSIS: A parallel-group, two-arm, randomized controlled trial will be carried out in two Australian EDs to compare long GW-PVADs (5.8 cm length) against standard care PVADs (short or long). Patients ≥18 years of age meeting DIVA criteria will be eligible for the trial. The sample size is 203 participants for each arm. Web-based central randomization will be used to ensure allocation concealment. Neither clinicians nor patients can be blinded to treatment allocation. Primary outcome is the first-insertion success rate. Secondary outcomes include the number of insertion attempts, time to insert PVAD, all-cause failure, dwell-time, patient-reported pain, serious adverse events, complications, subsequent vascular access devices required, patient satisfaction, staff satisfaction, and healthcare costs. Differences between the two groups will be analyzed using Cox proportional hazards regression. Cost-effectiveness analysis will also be conducted. Intention-to-treat analysis will be used. ETHICS AND DISSEMINATION The study is approved by Metro South Ethics Committee (HREC/2022/QMS/82264) and Griffith University (2022/077). The findings will be published in a peer-reviewed journal. TRIAL REGISTRATION ACTRN12622000299707.