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Completed

NCT Number: NCT01163981

Ultrasound Guided Cannulation of Dialysis Fistulas

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hull Royal Infirmary

Hull, East Yorkshire, HU3 2JZ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Dialysis 3X per week
  • Dialysing via 2 needles in fistula
  • 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:

  • Patient request
  • Patient non compliance with study protocol

Treatment and study plan

Use of ultrasound guidance in cannulation

Other

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

Other names: duplex ultrasound

Primary outcomes

  1. Time to establish dialysis

    Time frame: Within 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 outcomes

  1. - Patient reported pain scores Patient reported anxiety and pain

    Time frame: enrollment, two weeks and four weeks into trial

    Patient reported pain scores and anxiety scores recorded by questionnaire

  2. Number of cannulation attempts( skin punctures or passes of needle)

    Time frame: Within an average of 5 minutes into each of the next 12 consecutive dialysis session

    number of cannulation attempts required

  3. complications of needling

    Time frame: Within 2 hours of completing each of the next 12 consecutive dialysis sessions

    record presence of any complications due to needle insertion

  4. Referral for difficult needling during trial

    Time frame: From 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

Sponsors and collaborators

Lead sponsor

University of Hull

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 16, 2010
Registry last updated
Dec 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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