Creating a Buttonhole Tunnel Track by Repeated Needling of the AV Fistula on the Same Day in Patients on Hemodialysis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 4
- 主要终点
- Buttonhole survival
研究概览
简要总结
BACKGROUND: The patients diagnosed with end stage renal disease require dialysis and for that they need to have a vascular access for hemodialysis (HD) placed. Vascular access complications are the most common cause of hospitalization among patients in HD. An AV fistula (AVF) is a surgical connection made between an artery and a vein, created by a vascular specialist, typically placed in an arm. AV fistulas are the preferred vascular access for long-term dialysis. In order to be able to carry out an adequate and uncomplicated dialysis treatment, two needles have to be placed in the fistula. It requires specialized technical ability to install well-functioning needles in the vessels of an AVF. The buttonhole technique is one of the two recommended techniques. For the buttonhole technique, two puncture sites are selected in the fistula. Here, exactly in the same spot a needle is inserted with the same angle and direction until a fibrous tunnel is formed, like a hole for an ear ring. Cannulation is now possible with blunt needles which are gentler and reduce complications. The time required to create a buttonhole tunnel is 6-12 cannulations, ie 6-12 dialyses. It is crucial for the future survival of the tunnel tracks, that a maximum of one to two persons cannulates until the track is created. This is a logistic challenge in a busy dialysis unit and may result in using a cannulation technique that is not recommended. A less time consuming method to create the buttonhole tunnel track may increase the use of the technique. A new method has been used in several dialysis units in Denmark. Using this method the tunnel tracks are created in 1-3 dialyses by repeated cannulations (4-6 needles one at a time) in the same two puncture sites in the fistula. The experiences so far indicates that this method reduces the dialysis sessions needed to create the tunnel tracks with 4-10 sessions. Thus, the logistic challenges of ensuring continuity in persons creating the tunnel track will be reduced. The purpose of the research project is to investigate whether a new method for creating buttonhole tunnels will:
- Increase the number of well-functioning buttonholes.
- Be less painful for the patient.
- Reduce the number of dialysis needed to create the buttonhole tunnel track.
- Cause unchanged or fewer fistula associated complications and infections.
详细描述
Background: See above. Aims:To study whether a new method of creating a buttonhole tunnel tracks can reduce the incidence of buttonhole technique failure and the patients pain with needling.
Patients and Methods: A randomized, multi-center study enrolling 42 patients in hemodialysis from two HD units in Denmark. The study will begin end of May 2019.
Participants are randomized into 2 groups where cannulation will be carried out by a small group of dialysis nurses with experience and skills in buttonhole cannulation. In both groups the same nurse will carry out the cannulation the first four dialysis sessions. At the following sessions the cannulation will be carried out by the nurse/nurses responsible for the patient. The procedures throughout the study will be the same in both participating centers.
The control group (K): creating buttonhole tunnels according to the standard method, ie. cannulation with a single sharp cannula in the AVF at each dialysis for 6-12 dialyses until a blunt needle can be inserted.
The intervention group (I): creating buttonhole tunnels according to the new method, ie. repeated cannulation with several sharp needles (4-6 pieces) at each dialysis for 1-3 dialyses until a blunt cannula can be inserted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- 否
入选标准
- •chronic hemodialysis patients
- •at least 5 hemodialysis treatments with a blood flow ≥ 250 ml/min have been carried out
- •ability to speak and understand danish
排除标准
- •patients with an artificial heart valve
- •patients in high dose immunosuppressive treatment
- •patients with infections in their buttonholes
- •patients who are unable to provide informed consent
结局指标
主要结局
Buttonhole survival
时间窗: Follow up for 1 year after completed creation of buttonhole tunnel
Cannulation with a blunt needle in the buttonhole tunnel track is possible. Technique failure and non-survival is defined as inability to insert a blunt needle into the buttonhole tunnel tracks in three consecutive dialysis or inability to cannulate the established buttonhole track for more than two weeks.
次要结局
- Patient perceived pain post-needling(Measured at each cannulation until completed creation of buttonhole tunnel track (up to 24 dialyses=8 weeks))
研究者
Mette Axelsen
Clinical nurse specialist
Esbjerg Hospital - University Hospital of Southern Denmark
