Ultrasound Guided Cannulation of Dialysis Fistulas

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by University of Hull.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University of Hull
ClinicalTrials.gov Identifier:
NCT01163981
First received: July 12, 2010
Last updated: July 14, 2011
Last verified: July 2010
  Purpose

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.


Condition Intervention Phase
Haemodialysis
Other: Use of ultrasound guidance in cannulation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official 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

Resource links provided by NLM:


Further study details as provided by University of Hull:

Primary Outcome Measures:
  • Time to establish dialysis [ Time Frame: Within an average of 5 minutes into each of the next 12 consecutive dialysis session ] [ Designated as safety issue: No ]
    Time to commence 2 needle dialysis from first palpation or imaging of fistula


Secondary Outcome Measures:
  • - Patient reported pain scores Patient reported anxiety and pain [ Time Frame: enrollment, two weeks and four weeks into trial ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    number of cannulation attempts required

  • complications of needling [ Time Frame: Within 2 hours of completing each of the next 12 consecutive dialysis sessions ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Referral for difficult needling to either senior nurse or to access clinic during trial


Estimated Enrollment: 60
Study Start Date: November 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Blind cannulation
Cannulation without guidance
Experimental: Ultrasound guided cannulation
Ultrasound guided cannulation
Other: Use of ultrasound guidance in cannulation
Use of guidance with duplex ultrasound to complete cannulation of dialysis access
Other Name: duplex ultrasound

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01163981

Contacts
Contact: George E Smith, BSc MBBS MRCS 01482 674128 george.smith@hey.nhs.uk
Contact: Ian C Chetter, MBChB MD FRCS 01482 674178 ian.chetter@hey.nhs.uk

Locations
United Kingdom
Hull Royal Infirmary Not yet recruiting
Hull, East Yorkshire, United Kingdom, HU3 2JZ
Contact: George E Smith, BSc MBBS MRCS    01482674178    george.smith@hey.nhs.uk   
Principal Investigator: George E Smith, BSc MBBS MRCS         
Sponsors and Collaborators
University of Hull
Investigators
Principal Investigator: George E Smith, BSc MBBS MRCS Hull and East Yorkshire NHS Trust
  More Information

No publications provided

Responsible Party: Ian Chetter, Hull and East Yorkshire NHS Trust
ClinicalTrials.gov Identifier: NCT01163981     History of Changes
Other Study ID Numbers: Access 5
Study First Received: July 12, 2010
Last Updated: July 14, 2011
Health Authority: United Kingdom: National Health Service

Keywords provided by University of Hull:
duplex Ultrasound
Haemodialysis
Vascular Access

Additional relevant MeSH terms:
Arteriovenous Fistula
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities
Fistula
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 20, 2014