跳至主要内容
临床试验/NCT05081648
NCT05081648已完成不适用

A Randomised Control Trial of MuST Technique for Vascular Access Cannulation in Hemodialysis Patients: Contributions for a Safe Nursing Intervention

Fresenius Medical Care Deutschland GmbH6 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2022年1月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
101
试验地点
6
主要终点
Vascular access survival rate

研究概览

简要总结

The aims of this study are to:

  • Determine the AVF (arteriovenous fistula) survival of patients submitted to MuST compared to those submitted to RL (rope-ladder).
  • Determine the AVF (arteriovenous fistula) complication rate of patients submitted to MuST compared to those submitted to RL (rope-ladder).
  • Analyze the intensity of pain perceived by the patient with each cannulation technique under study.

详细描述

The MuST is based on the association between the RL technique in that it uses the entire length of the available vessel through progressive rotation, and the buttonhole (BH) cannulation technique since there are three specific cannulation sites for each cannulation day during the week, meaning that each site is only cannulated once a week (allowing the puncture site to heal in between cannulations).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
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

  • Voluntarily agree to participate in the study and sign an informed consent;
  • Are on a regular haemodialysis (HD) program with three weekly sessions;
  • AVF has been in use for at least 4 weeks without incident;
  • AVF with blood flow (Qa) ≥500 mL/min evaluated by thermodilution;
  • AVF paths allow cannulations along the entire length of the vein with at least 6 cm of distance between bevels, or two distinct areas of 3 cm in length;
  • Adult patients

排除标准

  • Those who decline to take part;
  • Those who have undergone angiography or surgical intervention in the last 4 months in the AVF in use;
  • Those who have undergone three or more interventions in the AVF in use;
  • Those with use of anesthetic creams at cannulation sites.

结局指标

主要结局

Vascular access survival rate

时间窗: 12 months after start of study

Vascular access (VA) survival rate at 12 months and determined by the percentage of fistulas in use from the beginning of the study to the date of the first clinical intervention by angioplasty or vascular surgery, to maintain or restore patency - "unassisted patency".

次要结局

  • Arteriovenous fistula survival rate(12 months after start of study)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (6)

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