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评估无针连接器反流:使用静脉模拟器对类别指定与台式功能进行盲法比较。

Assessment of Reflux From Needleless Connectors: Blinded Comparison of Category Designation to Benchtop Function Using a Venous Simulator.

机构信息

Department of Biomedical Engineering, Marquette University the Medical College of Wisconsin, Milwaukee, Wisconsin (Ms Gorzek and Dr LaDisa); Departments of Physiology and Medicine-Division of Cardiovascular Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin; Department of Pediatrics, Medical College of Wisconsin and The Herma Heart Institute, Section of Pediatric Cardiology, Children's Wisconsin, Milwaukee, Wisconsin (Dr LaDisa).

Sarah Gorzek, BS, earned her bachelor's degree in biomedical engineering with an emphasis on bioelectronics and a minor in engineering ethics from Marquette University. She is currently employed at Boston Scientific Corporation as a field clinical engineer in the Neuromodulation Division specializing in spinal cord and deep brain stimulation systems. Her responsibilities include supporting field execution and management of clinical trials while providing technical support to physicians and patients. Ms Gorzek's professional research focus is to optimize therapeutic benefits for patients that suffer from neuropathic pain and Parkinson's disease. Ms Gorzek's previous work experience includes assisting in developing custom tooling for spinal implants at Life Spine Inc. and supporting engineering research as a student technician at Marquette University's Discovery Learning Center.

出版信息

J Infus Nurs. 2021;44(6):323-330. doi: 10.1097/NAN.0000000000000447.

Abstract

Needleless connectors (NCs) for vascular access have limited needlestick injuries, but complications including occlusion, thrombosis, and infections have increased despite reduced needlestick injuries. These complications relate to the ability of an NC design to limit volume fluctuations that can lead to fluid reflux with potential for microbial contamination. Different NC designs requiring specific usage protocols and training, a lack of clarity in NC function relative to manufacturer-designated categories, and confounding results from a limited number of studies comparing different NCs have resulted in confusion, ultimately leading to complications from undesirable fluid movement within the vascular access. The authors therefore quantified the magnitude of reflux with current commercially available NCs using a venous stimulator. Thirteen blinded NC designs spanning the categories of negative and positive displacement, neutral, and antireflux were tested to quantify fluid movement upon disconnection and reconnection from a representative intravenous pressure (3 NCs per design; 10 trials per NC). Trials for each NC tested followed consistent displacement trends leading to tight error bars. Blinded NCs were then characterized according to their function and compared with their category designation after unblinding. All positive and negative NCs functioned in a manner consistent with their respective category designations. Conversely, all NCs categorized as neutral actually functioned with negative displacement (ie, reflux upon disconnection; 4/5 NCs) or positive displacement (1/5 NCs). Only NCs classified as antireflux functioned as neutral, which was confirmed in a blinded bidirectional flow test. These results suggest that the neutral NC-marketed category may be confusing to users unless the particular NC design has an integrated antireflux component.

摘要

无针连接器(NCs)在血管通路中有较少的针刺伤,但尽管针刺伤减少了,但并发症包括阻塞、血栓形成和感染却有所增加。这些并发症与 NC 设计的能力有关,这种能力可以限制可能导致液体反流和潜在微生物污染的体积波动。不同的 NC 设计需要特定的使用协议和培训,NC 功能相对于制造商指定的类别缺乏明确性,以及少数比较不同 NC 的研究结果存在混淆,最终导致血管通路内不希望的液体流动引起并发症。因此,作者使用静脉刺激器定量评估了目前市售 NC 的反流量。测试了 13 种盲目的 NC 设计,涵盖了负位移、正位移、中性和防反流的类别,以定量评估与代表静脉压的设备断开和重新连接时的液体流动(每个设计 3 个 NC,每个 NC 10 次试验)。每个 NC 的测试试验都遵循一致的位移趋势,导致误差线紧密。然后根据功能对盲 NC 进行分类,并在解除盲法后将其与类别指定进行比较。所有正位移和负位移 NC 都按照其各自类别的设计功能运作。相反,所有被归类为中性的 NC 实际上都具有负位移(即断开时反流;5 个 NC 中有 4 个)或正位移(5 个 NC 中有 1 个)功能。只有被归类为防反流的 NC 才能以中性方式运作,这在盲法双向流动测试中得到了证实。这些结果表明,除非特定的 NC 设计具有集成的防反流组件,否则中性 NC 标记类别可能会使用户感到困惑。

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