SECUREment bundles to prevent peripheral intravenous catheter failure—the SECURE-PIVC trial: study protocol for a pilot randomized controlled trial
Peripheral intravenous catheters (PIVCs) are widely used, but failure is unacceptably common with up to 69% failing before treatment is complete. PIVC securement reduces failure, but the optimal way to achieve this is unclear. Tapes and supplementary securement products are widely used, however rigorous testing of these to reduce PIVC failure remains unexplored.
Methods and analysis
In adult medical-surgical wards at a tertiary hospital, this pilot randomized controlled trial tests standard care (bordered polyurethane dressing plus nonsterile tape over the extension tubing) against two securement interventions (intervention one: standard care plus two sterile tape strips over the PIVC hub; intervention two: intervention one plus a tubular bandage). Patients >18 years of age requiring a PIVC for >24 hours are eligible. Patients with laboratory-confirmed positive blood cultures within 24 hours of screening, known allergy to study products, current or high-risk of skin tear, or non-English speaking without interpreter are excluded. Sample size is 35 per trial arm, and central randomization is computer-generated with allocation concealed until entry. Patients and clinical staff cannot be blinded to treatment allocation. However, infection outcomes are assessed by a blinded investigator. Primary outcome is study feasibility. Secondary outcomes (PIVC failure, dwell time, skin adverse events, PIVC colonization, and cost) are compared between groups. Feasibility outcomes are reported descriptively.
Ethics and trial commencement
Ethical approvals were received from Royal Brisbane and Women's Hospital (HREC/18/QRBW/44571) and Griffith University (2018/1000). Trial commencement was May 2019.
Peripheral intravenous catheters (PIVCs) are required by up to 70% of hospitalized patients to deliver medical treatment (Zingg & Pittet, 2009). However, despite their importance and widespread use, rates of PIVC failure and unscheduled reinsertions due to complications are reported to be between 30% and 69% (Bolton, 2010; Gunther et al., 2016; Marsh, Webster, Larsen Cooke, Mihala, & Rickard, 2018; Rickard, McCann, Munnings, & McGrail, 2010; Rickard et al., 2012; Smith, 2006; Rickard et al., 2018). Factors responsible for early failure include phlebitis, occlusion, infiltration, extravasation, dislodgement and infection (Bolton, 2010; Marsh et al., 2018; Rickard et al., 2010; Rickard et al., 2018). PIVC failure and subsequent resite may lead to pain, anxiety and distress for patients with repeated and frequent cannulation attempts, negatively impacting their hospital stay (Helm, Klausner, Klemperer, Flint, & Huang, 2015). Furthermore, PIVC failure is costly to the healthcare institution due to the human and material resources required to replace failed PIVCs, in addition to the cost of treating PIVC complications and any sequelae (Helm et al., 2015).
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