ISRCTN16275275终止未知
A mixed-methods trial to explore the feasibility of comparing buttonhole to rope ladder cannulation of arteriovenous fistulae for haemodialysis
niversity Hospitals of Derby and Burton NHS Foundation Trust0 个研究点目标入组 40 人开始时间: 2020年8月25日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 终止
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •The study will only include the following type of patients:
- •1. Adult, in-centre haemodialysis patients
- •2. Undergoing intermittent haemodialysis or haemodiafiltration, using an AV fistula that has been cannulated for haemodialysis for no longer than 6 months, using any cannulation technique and regularly using two needles for haemodialysis (i.e. more than 75% of the time)
- •3. Undergoing cannulation performed by registered or unregistered staff in the haemodialysis nursing team
- •4. Able and willing to complete a questionnaire, either independently or with support from a carer
- •5. Patients aged 18 years or older with the capacity to provide informed consent
- •6. Agree to not use topical or sub-dermal local anaesthetic during the cannulation procedure in the study period
- •Patients undergoing shared care, where they perform part of the cannulation procedure, will not excluded, as long as nursing staff insert the fistula needle.
- •As this is a feasibility study, it will also include:
- •Registered or unregistered nursing staff working in dialysis units, who perform cannulation of AV access for haemodialysis
排除标准
- •The study will exclude any haemodialysis patient with a clinical reason not to perform one of cannulation techniques*, which would prevent true randomisation. Criteria that should exclude patients for this reason include:
- •1. Grafted or stented sections on the AV fistula
- •2. Metallic heart valve or pacemaker
- •3. Previous positive MRSA screens of swabs in last 12 months
- •4. Previous positive MSSA screens of swabs in last 3 months or a history of more than 3 MSSA positive screens
- •5. Previous positive MRSA or MSSA bacteraemia in last 5 years
- •6. Previous endocarditis in the last 5 years
- •7. Previous or known allergy or skin reaction attributed to chlorhexidine or alcohol
- •8. Current rash or skin wounds over AV fistula vessel
- •9. Tortuous vessel with no straight segment of at least 7cm
- •10. Active infection in the AV fistula, being treated with antibiotics
- •11. Plan to perform a live related kidney transplant in next 6 months
- •12. Plan to self-cannulate or initiate carer cannulation in the next 6 months
- •*As per BRS & VASBI recommendations, buttonhole technique should be avoided in patients with high infection risk and rope ladder cannot be performed in vessel with short cannulation segment.
- •The following nursing staff will be excluded:
- •1. Nursing staff who have never performed cannulation of trial participants
- •2. Nursing staff undergoing training to perform cannulation of AV access for haemodialysis, who are yet not deemed competent to perform this without supervision
- •3. Student nurses or non-English nurses currently undertaking an adaption course to become registered nurses in the UK
- •4. Bank or agency nursing staff not employed by participating NHS renal units
研究者
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