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
1 other identifier
interventional
31
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 12, 2010
CompletedFirst Posted
Study publicly available on registry
July 16, 2010
CompletedStudy Start
First participant enrolled
November 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedDecember 17, 2020
October 1, 2018
6 months
July 12, 2010
December 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to establish dialysis
Time to commence 2 needle dialysis from first palpation or imaging of fistula
Within an average of 5 minutes into each of the next 12 consecutive dialysis session
Secondary Outcomes (4)
- Patient reported pain scores Patient reported anxiety and pain
enrollment, two weeks and four weeks into trial
Number of cannulation attempts( skin punctures or passes of needle)
Within an average of 5 minutes into each of the next 12 consecutive dialysis session
complications of needling
Within 2 hours of completing each of the next 12 consecutive dialysis sessions
Referral for difficult needling during trial
From enrollment to 24 hours following completion of the last of 12 consecutive dialysis sessions
Study Arms (2)
Blind cannulation
NO INTERVENTIONCannulation without guidance
Ultrasound guided cannulation
EXPERIMENTALUltrasound guided cannulation
Interventions
Use of guidance with duplex ultrasound to complete cannulation of dialysis access
Eligibility Criteria
You may qualify if:
- Dialysis 3X per week
- Dialysing via 2 needles in fistula
- No deviation from routine dialysis protocol (additional or no heparin etc)
You may not qualify if:
- a. Active or recent fistula infection/thrombosis/intervention in 6/52 of study
- Withdrawal criteria:
- Patient request
- Patient non compliance with study protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hull Royal Infirmary
Hull, East Yorkshire, HU3 2JZ, United Kingdom
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
George E Smith, BSc MBBS MRCS
Hull and East Yorkshire NHS Trust
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2010
First Posted
July 16, 2010
Study Start
November 1, 2016
Primary Completion
May 1, 2017
Study Completion
August 1, 2017
Last Updated
December 17, 2020
Record last verified: 2018-10