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Ultrasound Guided Cannulation of Dialysis Fistulas

Not Applicable
Completed
Conditions
Haemodialysis
Interventions
Other: Use of ultrasound guidance in cannulation
Registration Number
NCT01163981
Lead Sponsor
University of Hull
Brief Summary

The investigators suspect that using ultrasound to guide insertion of needles for dialysis patients will make this process quicker and more accurate, thus reducing complications and reducing discomfort for patients.

Detailed Description

Haemodialysis patients need to have two needles inserted into a large surgically altered vein (fistula) or surgical vascular graft/shunt for every dialysis session. Some fistulas or shunts may be more difficult to insert needles into than others. As such a system of colour coding or "traffic lighting" of patients is in place in most units. A "green light" patient is easy to "needle" with two needles and the majority of staff within the unit will be able to connect the patients to the dialysis machine. A "red light" patient is reserved for the more experienced staff within the unit who will often have to be timetabled to work specific times so that they are present to connect certain patients to the dialysis machines. "Amber light" fistulas lie between these two extremes.

Ultrasound (US) is routinely used in many hospitals and many dialysis units will have access to a machine to assess patients for problems. Indeed central venous line insertions for dialysis are now almost always performed under US guidance since two large studies in this area in 2002 provided strong evidence that US guided placement significantly reduces complications during catheter placement and a reduction in the number of attempts at insertion. In addition the National Institute of Clinical Excellence in the UK provided evidence that insertion time is quicker although this association was statistically less convincing.

Ultrasound offers the advantage of dynamic imaging without the risks of radiation exposure and can be done as an office based procedure using portable equipment.

Studies in emergency departments and particularly in paediatric care have suggested that US guidance can improve the speed and accuracy of cannulation in peripheral veins for intravenous access.

We suggest that US guided cannulation of fistulas might improve the cannulation rate of more difficult fistulas and potentially reduce the time required to commence dialysis and the number of local complications of cannulation (haematoma/aneurysm/infection).

To our knowledge US is not used in cannulation guidance in any dialysis units, although most units will have access to a machine as above. We therefore propose to perform a randomised controlled trial of US guided cannulation of fistulas versus current practice (blind cannulation) to assess the effectiveness of US controlled cannulation in a busy dialysis unit.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
31
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Ultrasound guided cannulationUse of ultrasound guidance in cannulationUltrasound guided cannulation
Primary Outcome Measures
NameTimeMethod
Time to establish dialysisWithin an average of 5 minutes into each of the next 12 consecutive dialysis session

Time to commence 2 needle dialysis from first palpation or imaging of fistula

Secondary Outcome Measures
NameTimeMethod
- Patient reported pain scores Patient reported anxiety and painenrollment, two weeks and four weeks into trial

Patient reported pain scores and anxiety scores recorded by questionnaire

Number of cannulation attempts( skin punctures or passes of needle)Within an average of 5 minutes into each of the next 12 consecutive dialysis session

number of cannulation attempts required

Referral for difficult needling during trialFrom enrollment to 24 hours following completion of the last of 12 consecutive dialysis sessions

Referral for difficult needling to either senior nurse or to access clinic during trial

complications of needlingWithin 2 hours of completing each of the next 12 consecutive dialysis sessions

record presence of any complications due to needle insertion

Trial Locations

Locations (1)

Hull Royal Infirmary

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Hull, East Yorkshire, United Kingdom

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