一种新型肠内喂养系统的可用性:总结性研究。

IF 1.3 Q4 ENGINEERING, BIOMEDICAL Medical Devices-Evidence and Research Pub Date : 2022-08-05 eCollection Date: 2022-01-01 DOI:10.2147/MDER.S367100
Osman Mohamed Elfadil, Edel Keaveney, Ankitaben Patel, Marwa G Abdelmagid, Ishani Patel, Jalpan Patel, Ryan T Hurt, Manpreet S Mundi
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引用次数: 1

摘要

背景:长期家庭肠内营养(HEN)在营养治疗中的应用在世界范围内正在增加。然而,HEN可能是一种影响生活质量(QoL)的行动受限体验。改善HEN患者的生活质量是营养学界的普遍目标。本研究评估了一种新型肠内喂养系统(EFS) Mobility+®的可用性。方法:对新手(NV)、非新手(NN)和医疗保健专业人员(HCP)进行了一项评估新型EFS可用性的总结性研究。NV组和NN组的受试者接受了熟悉培训,在培训中,他们被介绍给新的EFS,并按照使用说明(IFU)小册子完成填充袋、模拟喂食、冲洗(漂洗)和佩戴系统的步骤,随后是一个测试阶段,他们自己模拟系统的使用。HCP使用IFU和教学视频进行自我培训。在HCP中还测试了即用型(RTH)配方袋填充法。参与者的能力松散线圈管和坐,站,四处走动穿着一个充满喂食袋内斜挎包。结果:45名参与者完成了研究。所有参与者都成功并安全地模拟了新型EFS的使用,97.8%(44/45)的参与者在第一次尝试时就成功了。所有参与者都可以在斜挎包中佩戴新型EFS,并且在没有任何使用错误或安全问题的情况下四处走动。结论:在提供基本熟悉培训和书面IFU的情况下,所研究的新型EFS可安全用于预期使用人群,无论是否有肠内营养经验。此外,HCP可以通过教学视频成功地在该系统上进行自我训练。
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Usability of a Novel Enteral Feeding System: A Summative Study.

Background: Utilization of long-term home enteral nutrition (HEN) for nutrition therapy is increasing across the world. However, HEN can be a mobility-limiting experience affecting quality of life (QoL). Improvement of QoL for patients receiving HEN is a universal goal within the nutrition community. This study evaluated usability of Mobility+®, a novel enteral feeding system (EFS).

Methods: A summative study evaluating usability of the novel EFS was conducted with novices (NV), non-novices (NN), and healthcare professionals (HCP). Subjects in NV and NN groups received familiarization training where they were introduced to the novel EFS and walked through steps to fill pouch, simulate feeding, flush (rinse), and wear the system, using the Instructions for Use (IFU) booklet, followed by a testing session where they simulated system use on their own. HCP self-trained using the IFU and instructional videos. A fill from ready-to-hang (RTH) formula bag method was also tested in HCP. Participants' ability to loosely coil the tubing and sit, stand, and move around wearing a filled feeding pouch inside a crossbody bag was also evaluated.

Results: Forty-five participants completed the study. All participants successfully and safely simulated use of the novel EFS, with 97.8% (44/45) doing so on first attempt. All participants could wear the novel EFS in crossbody bag and move around without any use errors or safety issues.

Conclusion: The examined novel EFS can be safely used in intended use population, with or without previous experience with enteral nutrition, on provision of basic familiarization training and written IFU. Additionally, HCP can successfully self-train on this system with instructional videos.

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来源期刊
Medical Devices-Evidence and Research
Medical Devices-Evidence and Research ENGINEERING, BIOMEDICAL-
CiteScore
2.80
自引率
0.00%
发文量
41
审稿时长
16 weeks
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