References
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
Inserting a peripheral vascular access device (PVAD) promptly to administer drugs and fluids is crucial for the treatment of patients in emergency departments (ED). Failing to secure reliable vascular access could contribute to ED crowding, as well as delays in patient treatments and diagnostic testing (Witting, 2012). Despite PVAD insertion being one of the most common tasks for ED clinicians, the task remains challenging when considering one in three patients present with difficult venous access (DIVA; Rippey et al, 2016; Whalen et al, 2017). Patients with DIVA are often individuals who are overweight, without visible or palpable veins, IV drug users, receiving recent chemotherapy, or have medical conditions (eg, sickle cell disease; Fields et al, 2014; Rippey et al, 2016).
First PVAD insertion failure in DIVA patients is as high as 58% (Farrell et al, 2017; Kleidon et al, 2019; Larsen, 2010; Reigart et al, 2012). Repeated PVAD insertion not only causes patient distress, pain and dissatisfaction (Fields, Piela, & Ku, 2014), but also increases staff workload and organizational costs (Tuffaha et al, 2014). Failure to secure a PVAD in ED patients who are unstable or critically unwell can lead to a more invasive procedure, such as insertion of a central vascular access device (CVAD) (Schoenfeld et al, 2011). To increase insertion success, ultrasound is widely utilized to assess vein location and characteristics during PVAD insertion, to avoid ‘blind puncture’ (Bahl et al, 2016; van Loon et al, 2018). Findings from a systematic review suggest that ultrasound-guided insertion has a higher success rate compared with landmark insertion (81% versus 70%; van Loon et al, 2018).
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