跳至主要内容
临床试验/NCT02085486
NCT02085486撤回不适用

Ultrasound Assisted Puncture of AV Fistulas in Chronic Hemodialysis Patients After a Short Learning Program in Bed-side Ultrasound for Hemodialysis Nurses by an Index Nurse - an Outcome Study

Insel Gruppe AG, University Hospital Bern0 个研究点开始时间: 2017年8月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Rate of successful cannulations of an AV-fistula

研究概览

简要总结

The puncture of the vascular access in hemodialysis patients remains challenging even in the hands of experienced dialysis nurses. Unsuccessful punctures are associated with resource wastage, traumatism of the AV shunts, shortening of the effective dialysis time and poor patient satisfaction.

The use of ultrasound by emergency department nurses and technicians without prior ultrasound experience in patients with difficult intravenous access showed in several studies to be very efficient. The investigators expect to achieve similar results in cannulation of AV shunts by the dialysis nurse staff after a short learning program.

To show this, the investigators aim to conduct a trail where standard cannulation technique (inspection, palpation) will be compared with the ultrasound-assisted method in terms of efficacy, safety and patient satisfaction.

详细描述

Background

The vascular access plays a central role in patients with end-stage renal disease undergoing chronic hemodialysis. It is well documented from various previous studies that the confection of the dialysis access and subsequent complications represent a major cause of morbidity, hospitalization and additional costs in chronic dialysis patients.

In European countries most patients undergoing chronic hemodialysis use an arterio-venous fistula as permanent vascular access. Because of the anatomical differences of each individual and the accompanying chronic diseases affecting patients' vessels, cannulation of arterio-venous fistulas can be very challenging for the nursing personal and puncture failures necessitating repeated attempts are not so rare. The latter are often time-consuming and result in a loss of effective dialysis' time and reduced proceeded total blood volume, are associated with a higher rate of local complications due to repeated traumatisms of the vascular wall and can lead to severe pain with reduced patient satisfaction.

In the investigators' dialysis unit, when a dialysis nurse is not able to puncture a fistula she refers to an experienced nurse who tries to cannulate the fistula after thorough visual and palpatory evaluation. In case of another failure, the nursing team refers to the dialysis physician, who performs a short diagnostic bed-side ultrasound of the vascular access to rule out the presence of thrombosis or large hematoma. Using ultrasound-guidance provided by the physician or after being informed about the localization and depth of the ideal puncture site, the dialysis nurse tries then to puncture the fistula again. This often leads to a greater loss of time with reduced effective dialysis dose, increased need for human resources and low patient satisfaction.

The use of ultrasound by emergency department nurses and technicians without prior ultrasound experience in patients with difficult intravenous access showed in several studies to be very efficient. The method was safe, the procedure rapid, the patients more satisfied, the success rate as high as this from ultrasound trained emergency physicians and the need for physician intervention reduced. The achievement of similar results in AV fistula cannulation in hemodialysis patients would be very suitable.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Forearm or upper arm AV-shunt (native, mixed, graft)
  • Patients with recognized difficult vascular access at any time (potentially each patient)
  • Written informed consent
  • Exclusion Criteria
  • Recent AV-shunt surgery (< 48 h)
  • Presence of large bandages or severe skin lesions in the area of interest
  • Inability to understand the aim of the study and to give a written informed consent
  • Single needle

排除标准

  • 未提供

结局指标

主要结局

Rate of successful cannulations of an AV-fistula

时间窗: Immediately after the cannulation, expected to be after 10 minutes on average

Satisfactory puncture of the fistula defined as the ability to achieve a full length dialysis (max. 10% reduction of the usual dialysis time), double-needle, and the usual blood flow rate (max. 15% reduction of the usual blood flow)

次要结局

  • Number of patients with late complications(At the following dialysis session, expected to be after 2-3 days)
  • Effective dialysis time(Directly after the treatment, expected to be after 3 to 4.5 hours)
  • Processed volume(Directly after the treatment, expected to be after 3 to 4.5 hours)
  • Patient satisfaction(Immediately after the canulation, expected to be after 10 minutes on average, and at the following dialysis session, expected to be after 2-3 days)

研究者

申办方类型
Other
责任方
Sponsor

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