Ultrasound Guided Cannulation of Dialysis Fistulas
Recruitment status was Not yet recruiting
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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 |
- 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
- - 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 |
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
Contacts and Locations| 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 |
| 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 | |
| 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 May 23, 2013