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一种用于减轻血液透析中血管通路出血的带夹系统集成报警器:一项前瞻性队列混合方法研究。

An integrated alarm with clamp system to mitigate vascular access bleeding in hemodialysis: a prospective cohort mixed methods study.

作者信息

Chan Ryan J, McGrath-Chong Margaret, Chan Christopher T M

机构信息

Division of Nephrology, University Health Network, 200 Elizabeth Street 8N Room 846, Toronto, ON, M5G 2C4, Canada.

出版信息

BMC Nephrol. 2025 Jul 17;26(1):398. doi: 10.1186/s12882-025-04332-8.

DOI:10.1186/s12882-025-04332-8
PMID:40676535
Abstract

Establishing and maintaining a functional vascular access is essential for patients with end-stage kidney disease on home hemodialysis. Due to patient safety concerns about vascular access complications, particularly needle dislodgement causing bleeding, various technologies have emerged. The purpose of this study was to investigate whether a novel device (developed by Redsense Medical AB) consisting of a sensor placed at the venous puncture site and linked to a base unit with wireless connection to a clamp on the venous line is acceptable from a patient perspective and feasible for implementation in a home hemodialysis program. This was a prospective cohort study of patients undergoing home hemodialysis at the University Health Network in Toronto, Ontario, Canada. We conducted a mixed methods study with a convergent parallel design, collecting both quantitative and qualitative data through two patient questionnaires whereby patients rated their experience with the Redsense system after their first 1-3 treatments and after their last treatment with the system. Thematic analysis was performed with use of open coding and axial coding. Quantitative data was presented as a heat map depicting participants' scoring of the Redsense system. Differences between the two questionnaires were assessed by Wilcoxon matched-pairs signed rank tests, and the response to select questions were depicted graphically. 21 patients consented to participate in this study, completing a total of 218 dialysis treatments with the Redsense system. Over these treatments, the system was shown to be safe and feasible for patients to use independently at home. The alarm had a relatively elevated false positive rate for both alarm triggering and clamp closure, with this sentiment well described in the qualitative data, as the nuisance of false alarms was a frequent concern described in the post-treatment questionnaire. Patients had other negative comments related to the practicality of the alarm system, the additional burden created, and concern about technical issues relating to wireless technology. Taken together, the data from this study suggest that most patients performing home hemodialysis independently feel that the potential benefits of the Redsense alarm system are outweighed by the additional burden and other negatives associated with the system.

摘要

对于接受家庭血液透析的终末期肾病患者而言,建立并维持有效的血管通路至关重要。出于对血管通路并发症(尤其是针头移位导致出血)的患者安全考虑,各种技术应运而生。本研究的目的是调查一种由Redsense Medical AB公司研发的新型装置,该装置由放置在静脉穿刺部位的传感器组成,并通过无线连接与静脉管路上的夹子相连的底座单元,从患者角度来看是否可接受,以及在家庭血液透析项目中实施是否可行。这是一项对加拿大安大略省多伦多大学健康网络中接受家庭血液透析的患者进行的前瞻性队列研究。我们采用了收敛平行设计的混合方法研究,通过两份患者问卷收集定量和定性数据,患者在首次进行1 - 3次治疗后以及最后一次使用该系统治疗后对他们使用Redsense系统的体验进行评分。使用开放编码和轴心编码进行主题分析。定量数据以热图形式呈现,表示参与者对Redsense系统的评分。通过Wilcoxon配对符号秩检验评估两份问卷之间的差异,并以图形方式描绘对选定问题的回答。21名患者同意参与本研究,使用Redsense系统共完成了218次透析治疗。在这些治疗过程中,该系统被证明对患者在家中独立使用是安全可行的。警报在触发警报和关闭夹子方面都有相对较高的误报率,定性数据很好地描述了这种情况,因为误报的困扰是治疗后问卷中经常提到的担忧。患者还有其他与警报系统实用性、产生的额外负担以及对无线技术相关技术问题的担忧等负面评论。综上所述,本研究数据表明,大多数独立进行家庭血液透析患者认为Redsense警报系统的潜在益处被该系统带来的额外负担和其他负面影响所抵消。

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本文引用的文献

1
Vascular Access Considerations in Home Hemodialysis.家庭血液透析中的血管通路考虑因素。
Clin J Am Soc Nephrol. 2024 Aug 1;19(8):1036-1044. doi: 10.2215/CJN.0000000000000499. Epub 2024 May 21.
2
Patient-Centered Home Hemodialysis: Approaches and Prescription.以患者为中心的家庭血液透析:方法和处方。
Clin J Am Soc Nephrol. 2024 Apr 1;19(4):517-524. doi: 10.2215/CJN.0000000000000292. Epub 2023 Aug 28.
3
Detection of Hemodialysis Venous Needle Dislodgment Using Venous Access Pressure Measurements: A Simulation Study.利用静脉通路压力测量检测血液透析静脉内针脱出:一项模拟研究。
Kidney360. 2023 Apr 1;4(4):e476-e485. doi: 10.34067/KID.0000000000000093. Epub 2023 Mar 24.
4
Home Hemodialysis: Core Curriculum 2021.家庭血液透析:2021 年核心课程。
Am J Kidney Dis. 2021 Dec;78(6):876-885. doi: 10.1053/j.ajkd.2021.01.025. Epub 2021 Sep 11.
5
KDOQI Clinical Practice Guideline for Vascular Access: 2019 Update.KDIGO 临床实践指南:血管通路 2019 更新版。
Am J Kidney Dis. 2020 Apr;75(4 Suppl 2):S1-S164. doi: 10.1053/j.ajkd.2019.12.001. Epub 2020 Mar 12.
6
A prototype line clamp for venous access bleeding in hemodialysis: A prospective cohort study.一种用于血液透析中静脉通路出血的原型血管夹:一项前瞻性队列研究。
Hemodial Int. 2019 Apr;23(2):151-157. doi: 10.1111/hdi.12737. Epub 2019 Feb 19.
7
The care and keeping of vascular access for home hemodialysis patients.家庭血液透析患者血管通路的护理与维护。
Hemodial Int. 2015 Apr;19 Suppl 1:S80-92. doi: 10.1111/hdi.12242.
8
Patient selection and training for home hemodialysis.家庭血液透析的患者选择与培训
Hemodial Int. 2015 Apr;19 Suppl 1:S71-9. doi: 10.1111/hdi.12254.
9
Patient and caregiver perspectives on home hemodialysis: a systematic review.患者和照护者对家庭血液透析的看法:系统评价。
Am J Kidney Dis. 2015 Mar;65(3):451-63. doi: 10.1053/j.ajkd.2014.10.020. Epub 2015 Jan 10.
10
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Am J Kidney Dis. 2015 Jan;65(1):116-21. doi: 10.1053/j.ajkd.2014.08.013. Epub 2014 Oct 16.