IV securement bundles RCT
Abstract:
Background: Peripheral intravenous catheters (PIVCs) are ubiquitous in acute care settings however failure rates are unacceptably high, with around half failing before prescribed treatment is complete. The most effective dressing and securement option to prolong PIVC longevity is unclear.
Objectives: To determine feasibility of conducting a definitive randomized controlled trial (RCT) investigating evidence-based securement bundles (medical adhesive tapes and supplementary securement products) to reduce PIVC failure.
Methods: In this pilot non-masked 3-group RCT, adults requiring a PIVC for >24 hrs were randomized to Standard care (bordered polyurethane dressing plus non-sterile tape over extension tubing), Securement Bundle 1 (two sterile tape strips over PIVC hub plus Standard care) or Securement Bundle 2 (Bundle 1 plus tubular bandage) with allocation concealed until study entry.
Exclusions: laboratory-confirmed positive blood culture, current/high-risk of skin tear, or study product allergy.
Primary outcome: feasibility (eligibility, recruitment, retention, protocol fidelity, participant/staff satisfaction).
Secondary outcomes: PIVC failure, PIVC dwell time, adverse skin events, PIVC colonization and cost.
Results: Of 109 randomized participants, 104 were included in final analyses. Feasibility outcomes were met, except eligibility criterion (79%). Absolute PIVC failure was 38.2% (13/34) for Bundle 2, 25% (9/36) for Bundle 1 and 23.5% (8/34) for Standard care. Incidence rate ratio for PIVC failure/1000 catheter days, compared to Standard care, was 1.1 (95% confidence interval [CI] 0.4-2.7) and 2.1 (95% CI 0.9-5.1) for Bundles 1 and 2, respectively.
Conclusions: A large RCT testing securement bundles is feasible, with adjustment to screening processes. Innovative dressing and securement solutions are needed to reduce unacceptable PIVC failure rates.
Trial registration ACTRN12619000026123.
Reference:
Corley A, Ullman AJ, Marsh N, Genzel J, Larsen EN, Young E, Booker C, Harris PNA, Rickard CM. A pilot randomized controlled trial of securement bundles to reduce peripheral intravenous catheter failure. Heart Lung. 2022 Aug 26;57:45-53. doi: 10.1016/j.hrtlng.2022.07.015. Epub ahead of print. PMID: 36041346.