Ultrasound Guided Cannulation of Dialysis Fistulas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01163981
Recruitment Status : Unknown
Verified July 2010 by University of Hull.
Recruitment status was:  Not yet recruiting
First Posted : July 16, 2010
Last Update Posted : July 15, 2011
Information provided by:
University of Hull

July 12, 2010
July 16, 2010
July 15, 2011
November 2011
May 2012   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01163981 on Archive Site
  • - 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
  • 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
  • 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
  • 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
Same as current
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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
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.

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.

Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Other: Use of ultrasound guidance in cannulation
Use of guidance with duplex ultrasound to complete cannulation of dialysis access
Other Name: duplex ultrasound
  • No Intervention: Blind cannulation
    Cannulation without guidance
  • Experimental: Ultrasound guided cannulation
    Ultrasound guided cannulation
    Intervention: Other: Use of ultrasound guidance in cannulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
August 2012
May 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United Kingdom
Access 5
Not Provided
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Ian Chetter, Hull and East Yorkshire NHS Trust
University of Hull
Not Provided
Principal Investigator: George E Smith, BSc MBBS MRCS Hull and East Yorkshire NHS Trust
University of Hull
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP