Haemodialysis Urological and Genital Diseases
Conditions
Interventions
Participants will be randomised to either use buttonhole or rope ladder cannulation technique, when initiating their haemodialysis treatment, for a period of 6 months. To be able to perform haemodialy
Sponsors
University Hospitals of Derby and Burton NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility outcomes: 1. Time to complete clinical outcome data collection measured by timing how long it takes to complete CRF for 5 patients at baseline, and monthly for 6 months 2. Completion rates of data measured by % of missing date from CRF and patient’s perspective of needling questionnaire at 6 months 3. Recruitment rates as defined as the number of patients: 3.1. Available on haemodialysis 3.2. Eligible for the study 3.3. Approached to participate in the study 3.4. Recruited to the study 3.5. Retained within the six month study period measured using the screening log and enrolment log at the end of trial 4. Reasons for non-participation in study measured using the screening log at the end of trial 5. Reasons for loss-to-follow up measured using loss to follow up semi-structured interviews and loss to follow up questionnaire on withdrawal from trial 6. Patients experiences of being part of the study measured using patient evaluation questionnaire and patient feasibility semi-structured interviews at 6 months 7. Staff experiences of being part of the study measured using the staff evaluation questionnaire and staff semi-structured focus groups at the end of trial (added 26/08/2020): 8. Fidelity of the cannulation procedure measured by structured observation using an Observation Checklist in a random selection of 4 participants (1 on each study arm at each site) each month throughout the trial | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Patient experience of needling measured using the patient’s perspective of needling questionnaire (PPN) and patient experience semi-structured interviews monthly for 6 months 2. Patency of AVF fistula measured by: 2.1. Length of time AV fistula used for 2.2. Number of procedures to correct AV fistula function 2.3. Miscannulation 2.4. Fistula problems all at 6 months 3. Infection measured throughout the study using: 3.1. Rate of bacteraemia (determined by positive blood culture) 3.2. Rate of exit-site infection (determined by positive wound swab with signs of infection (redness, heat. exudate or pus) | — |
Countries
England, United Kingdom
Outcome results
None listed