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Ultrasound Guided Cannulation of Dialysis Fistulas

Primary Purpose

Haemodialysis

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Use of ultrasound guidance in cannulation
Sponsored by
University of Hull
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Haemodialysis focused on measuring duplex Ultrasound, Haemodialysis, Vascular Access

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hull Royal Infirmary

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Blind cannulation

Ultrasound guided cannulation

Arm Description

Cannulation without guidance

Ultrasound guided cannulation

Outcomes

Primary Outcome Measures

Time to establish dialysis
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
Patient reported pain scores and anxiety scores recorded by questionnaire
Number of cannulation attempts( skin punctures or passes of needle)
number of cannulation attempts required
complications of needling
record presence of any complications due to needle insertion
Referral for difficult needling during trial
Referral for difficult needling to either senior nurse or to access clinic during trial

Full Information

First Posted
July 12, 2010
Last Updated
December 15, 2020
Sponsor
University of Hull
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1. Study Identification

Unique Protocol Identification Number
NCT01163981
Brief Title
Ultrasound Guided Cannulation of Dialysis Fistulas
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Hull

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Haemodialysis
Keywords
duplex Ultrasound, Haemodialysis, Vascular Access

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Blind cannulation
Arm Type
No Intervention
Arm Description
Cannulation without guidance
Arm Title
Ultrasound guided cannulation
Arm Type
Experimental
Arm Description
Ultrasound guided cannulation
Intervention Type
Other
Intervention Name(s)
Use of ultrasound guidance in cannulation
Other Intervention Name(s)
duplex ultrasound
Intervention Description
Use of guidance with duplex ultrasound to complete cannulation of dialysis access
Primary Outcome Measure Information:
Title
Time to establish dialysis
Description
Time to commence 2 needle dialysis from first palpation or imaging of fistula
Time Frame
Within an average of 5 minutes into each of the next 12 consecutive dialysis session
Secondary Outcome Measure Information:
Title
- Patient reported pain scores Patient reported anxiety and pain
Description
Patient reported pain scores and anxiety scores recorded by questionnaire
Time Frame
enrollment, two weeks and four weeks into trial
Title
Number of cannulation attempts( skin punctures or passes of needle)
Description
number of cannulation attempts required
Time Frame
Within an average of 5 minutes into each of the next 12 consecutive dialysis session
Title
complications of needling
Description
record presence of any complications due to needle insertion
Time Frame
Within 2 hours of completing each of the next 12 consecutive dialysis sessions
Title
Referral for difficult needling during trial
Description
Referral for difficult needling to either senior nurse or to access clinic during trial
Time Frame
From enrollment to 24 hours following completion of the last of 12 consecutive dialysis sessions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George E Smith, BSc MBBS MRCS
Organizational Affiliation
Hull and East Yorkshire NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hull Royal Infirmary
City
Hull
State/Province
East Yorkshire
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom

12. IPD Sharing Statement

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Ultrasound Guided Cannulation of Dialysis Fistulas

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