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Ultrasound Guided Cannulation of Dialysis Fistulas

A Randomised Controlled Trial of the Effectiveness of Ultrasound Guidance in Cannulation of Dialysis Arteriovenous Fistulas and Grafts in a University Hospital Dialysis Unit

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01163981
Enrollment
31
Registered
2010-07-16
Start date
2016-11-30
Completion date
2017-08-31
Last updated
2020-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Haemodialysis

Keywords

duplex Ultrasound, Haemodialysis, Vascular Access

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.

Interventions

OTHERUse of ultrasound guidance in cannulation

Use of guidance with duplex ultrasound to complete cannulation of dialysis access

Sponsors

University of Hull
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Dialysis 3X per week 2. Dialysing via 2 needles in fistula 3. No deviation from routine dialysis protocol (additional or no heparin etc)

Exclusion criteria

a. Active or recent fistula infection/thrombosis/intervention in 6/52 of study Withdrawal criteria: 1. Patient request 2. Patient non compliance with study protocol

Design outcomes

Primary

MeasureTime frameDescription
Time to establish dialysisWithin an average of 5 minutes into each of the next 12 consecutive dialysis sessionTime to commence 2 needle dialysis from first palpation or imaging of fistula

Secondary

MeasureTime frameDescription
- Patient reported pain scores Patient reported anxiety and painenrollment, two weeks and four weeks into trialPatient 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 sessionnumber of cannulation attempts required
complications of needlingWithin 2 hours of completing each of the next 12 consecutive dialysis sessionsrecord presence of any complications due to needle insertion
Referral for difficult needling during trialFrom enrollment to 24 hours following completion of the last of 12 consecutive dialysis sessionsReferral for difficult needling to either senior nurse or to access clinic during trial

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026