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实施和评估外周短导管冲洗指南:一项阶梯式楔形群随机试验。

Implementation and evaluation of short peripheral intravenous catheter flushing guidelines: a stepped wedge cluster randomised trial.

机构信息

School of Nursing and Centre for Healthcare Transformation, Queensland University of Technology, Brisbane, QLD, Australia.

Alliance for Vascular Access Teaching and Research (AVATAR), Menzies Health Institute Queensland, Griffith University, Brisbane, QLD, Australia.

出版信息

BMC Med. 2020 Sep 30;18(1):252. doi: 10.1186/s12916-020-01728-1.

Abstract

BACKGROUND

Peripheral intravenous catheters (PIVCs) are ubiquitous medical devices, crucial to providing essential fluids and drugs. However, post-insertion PIVC failure occurs frequently, likely due to inconsistent maintenance practice such as flushing. The aim of this implementation study was to evaluate the impact a multifaceted intervention centred on short PIVC maintenance had on patient outcomes.

METHODS

This single-centre, incomplete, stepped wedge, cluster randomised trial with an implementation period was undertaken at a quaternary hospital in Queensland, Australia. Eligible patients were from general medical and surgical wards, aged ≥ 18 years, and requiring a PIVC for > 24 h. Wards were the unit of randomisation and allocation was concealed until the time of crossover to the implementation phase. Patients, clinicians, and researchers were not masked but infections were adjudicated by a physician masked to allocation. Practice during the control period was standard care (variable practice with manually prepared flushes of 0.9% sodium chloride). The intervention group received education reinforcing practice guidelines (including administration with manufacturer-prepared pre-filled flush syringes). The primary outcome was all-cause PIVC failure (as a composite of occlusion, infiltration, dislodgement, phlebitis, and primary bloodstream or local infection). Analysis was by intention-to-treat.

RESULTS

Between July 2016 and February 2017, 619 patients from 9 clusters (wards) were enrolled (control n = 306, intervention n = 313), with 617 patients comprising the intention-to-treat population. PIVC failure was 91 (30%) in the control and 69 (22%) in the intervention group (risk difference - 8%, 95% CI - 14 to - 1, p = 0.032). Total costs were lower in the intervention group. No serious adverse events related to study intervention occurred.

CONCLUSIONS

This study demonstrated the effectiveness of post-insertion PIVC flushing according to recommended guidelines. Evidence-based education, surveillance and products for post-insertion PIVC management are vital to improve patient outcomes.

TRIAL REGISTRATION

Trial submitted for registration on 25 January 2016. Approved and retrospectively registered on 4 August 2016. Ref: ACTRN12616001035415 .

摘要

背景

外周静脉导管(PIVC)是一种无处不在的医疗设备,对于提供必需的液体和药物至关重要。然而,插入后 PIVC 失败经常发生,这可能是由于冲洗等维护实践不一致所致。本实施研究旨在评估以 PIVC 短期维护为中心的多方面干预对患者结局的影响。

方法

这是一项在澳大利亚昆士兰州一家四所医院进行的单中心、不完全、逐步楔形、集群随机试验,包括实施阶段。符合条件的患者来自普通内科和外科病房,年龄≥18 岁,需要 PIVC 持续使用超过 24 小时。病房是随机分组单位,直到进入实施阶段时才进行分组隐藏。患者、临床医生和研究人员没有被蒙蔽,但感染由一名对分组不知情的医生裁决。对照期的实践是标准护理(使用手动准备的 0.9%氯化钠冲洗液的可变实践)。干预组接受了强化实践指南的教育(包括使用制造商预填充冲洗注射器进行管理)。主要结局是所有原因的 PIVC 失败(作为闭塞、渗透、移位、静脉炎和原发性血流或局部感染的复合指标)。分析采用意向治疗。

结果

2016 年 7 月至 2017 年 2 月,9 个(病房)集群的 619 名患者入组(对照组 n=306,干预组 n=313),617 名患者构成意向治疗人群。对照组的 PIVC 失败率为 91(30%),干预组为 69(22%)(风险差异-8%,95%CI-14 至-1,p=0.032)。干预组的总费用较低。与研究干预相关的严重不良事件未发生。

结论

本研究表明,根据推荐指南进行 PIVC 插入后冲洗是有效的。基于证据的 PIVC 管理教育、监测和产品对于改善患者结局至关重要。

试验注册

试验于 2016 年 1 月 25 日提交注册。2016 年 8 月 4 日批准并进行了回顾性注册。注册号:ACTRN12616001035415 。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2bf3/7526260/a3a2f69815e4/12916_2020_1728_Fig1_HTML.jpg

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