School of Nursing and Midwifery, Griffith University, Nathan, 4111, Australia; Nursing and Midwifery Research Centre, Royal Brisbane and Women's Hospital, Herston, 4006, Australia; School of Nursing, Midwifery and Social Work, University of Queensland, St. Lucia, 4067, Australia; Menzies Health Institute Queensland, Griffith University, Nathan, 4111, Australia.
School of Nursing and Midwifery, Griffith University, Nathan, 4111, Australia; Nursing and Midwifery Research Centre, Royal Brisbane and Women's Hospital, Herston, 4006, Australia; School of Nursing, Midwifery and Social Work, University of Queensland, St. Lucia, 4067, Australia; Queensland Children's Hospital, Children's Health Queensland, South Brisbane, 4101, Australia.
Heart Lung. 2023 Jan-Feb;57:45-53. doi: 10.1016/j.hrtlng.2022.07.015. Epub 2022 Aug 27.
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.
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.
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.
laboratory-confirmed positive blood culture, current/high-risk of skin tear, or study product allergy.
feasibility (eligibility, recruitment, retention, protocol fidelity, participant/staff satisfaction).
PIVC failure, PIVC dwell time, adverse skin events, PIVC colonization and cost.
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.
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.
外周静脉导管（PIVC）在急症护理环境中无处不在，但其失败率高得令人无法接受，大约有一半的导管在规定的治疗完成之前就失效了。延长 PIVC 使用寿命的最有效敷料和固定选择尚不清楚。
确定进行一项确定的随机对照试验（RCT）的可行性，该试验调查基于证据的固定套件（医用胶带和补充固定产品）以减少 PIVC 失败的情况。
在这项试点性非盲 3 组 RCT 中，需要 PIVC 超过 24 小时的成年人被随机分配到标准护理（边界型聚氨酯敷料加延伸管上的非无菌胶带）、固定套件 1（两个无菌胶带条加在 PIVC 管座上，外加标准护理）或固定套件 2（套件 1 加管状绷带），直到研究开始时才进行分配隐藏。
实验室确认的阳性血培养、当前/高皮肤撕裂风险，或研究产品过敏。
可行性（合格性、招募、保留率、方案一致性、参与者/工作人员满意度）。
PIVC 失败、PIVC 留置时间、不良皮肤事件、PIVC 定植和成本。
在 109 名随机参与者中，有 104 名参与者被纳入最终分析。除合格性标准（79%）外，其他可行性结果均得到满足。固定套件 2 的绝对 PIVC 失败率为 38.2%（13/34），固定套件 1 为 25%（9/36），标准护理为 23.5%（8/34）。与标准护理相比，PIVC 失败/1000 导管日的发生率比为 1.1（95%置信区间[CI]0.4-2.7）和 2.1（95% CI 0.9-5.1），分别为套件 1 和 2。
一项大型 RCT 测试固定套件是可行的，可通过调整筛选过程进行改进。需要创新的敷料和固定解决方案来降低不可接受的 PIVC 失败率。试验注册 ACTRN12619000026123。
