Impact of the Arteriovenous Fistula Puncture Technique On the Hemodialysis Session For Patient and Caregiver
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Compression time required for hemostasis
研究概览
简要总结
40000 patients are hemodialysis each year in France .
In the case of chronic care, 78% of patients have an arteriovenous fistula. In order to perform the hemodialysis session, 2 techniques of puncture of the fistula are possible:
- Bevel puncture upwards then flipping the needle
- or puncture bevel down. At present, there is no consensus or study on the technique of puncture fistula which generates different professional practices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient in chronic renal failure treated by hemodialysis with native arteriovenous fistula as a vascular approach.
- •Adult of age and sex indifferent.
- •Normal puncture of the fistula with two needles (bipuncture).
- •Fistula use for more than 3 months.
- •Beneficiary of Medicare or State Medical Aid.
- •No opposition to participation in the study.
排除标准
- •Patient who does not speak and does not understand French.
- •Hemodialysis patient awaiting a transplant by a living donor.
- •Patient with more than 2 AVF dilatations in the last 6 months.
- •Patient with prosthetic arteriovenous fistula.
研究组 & 干预措施
puncture bevel domn
干预措施: pucture in the arteriovenous fistula (Device)
puncture bevel up
干预措施: pucture in the arteriovenous fistula (Device)
结局指标
主要结局
Compression time required for hemostasis
时间窗: period of 3 weeks
The primary endpoint is the compression time required for hemostasis after needle removal, which is stable over a 3-week period. The compression time will be measured with a stopwatch so that it is objective and accurate, although the compression times range from minute to minute. An initial 2-week observation phase (phase 1) will establish a reference time for each patient using the most common puncture technique in the department: bevel up. We will evaluate the patient's reference time by counting the time of compression using a stopwatch for 2 weeks (ie 6 sessions) and we will take an average. A draw will determine for each patient the order in which the direction of the needles will be used. After this determination of the reference time, the patient will enter two successive phases where it will be tapped bevel up (phase 2) and then down (phase 3) or vice versa following the draw.
次要结局
未报告次要终点
研究者
Valérie LOIZEAU
Impact of the Arteriovenous Fistula Puncture Technique On the Hemodialysis Session For Patient and Caregiver
Poissy-Saint Germain Hospital