Is it feasible to compare two methods of needle insertions for use in kidney dialysis treatment?
- Conditions
- HaemodialysisUrological and Genital Diseases
- Registration Number
- ISRCTN16275275
- Lead Sponsor
- niversity Hospitals of Derby and Burton NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped
- Sex
- All
- Target Recruitment
- 40
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method