HaemodialysisNCT01163981
Ultrasound Guided Cannulation of Dialysis Fistulas
A study testing Use of ultrasound guidance in cannulation in people with Haemodialysis, run by University of Hull at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Haemodialysis
- What is being tested?
- Use of ultrasound guidance in cannulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2016to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dialysis 3X per week
- Dialysing via 2 needles in fistula
- No deviation from routine dialysis protocol (additional or no heparin etc)
Who cannot join
- Active or recent fistula infection/thrombosis/intervention in 6/52 of study
- Withdrawal criteria:
- Patient request
- Patient non compliance with study protocol
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Hull Royal Infirmary
Hull, East Yorkshire, HU3 2JZ
About this study
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
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.
Read the 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.
- Conditions
- Haemodialysis
- Being tested
- Use of ultrasound guidance in cannulation
- Keywords
- duplex Ultrasound, Haemodialysis, Vascular Access
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of ultrasound guidance in cannulationOther
Also called duplex ultrasound
Use of guidance with duplex ultrasound to complete cannulation of dialysis access
| Study group | Role | What they receive |
|---|---|---|
| Blind cannulation | No intervention | Cannulation without guidance |
| Ultrasound guided cannulation | Experimental | Ultrasound guided cannulation Receives: Other: Use of ultrasound guidance in cannulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to establish dialysis
Time to commence 2 needle dialysis from first palpation or imaging of fistula
Measured: 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
Patient reported pain scores and anxiety scores recorded by questionnaire
Measured: enrollment, two weeks and four weeks into trial
Number of cannulation attempts( skin punctures or passes of needle)
number of cannulation attempts required
Measured: Within an average of 5 minutes into each of the next 12 consecutive dialysis session
complications of needling
record presence of any complications due to needle insertion
Measured: Within 2 hours of completing each of the next 12 consecutive dialysis sessions
Referral for difficult needling during trial
Referral for difficult needling to either senior nurse or to access clinic during trial
Measured: From enrollment to 24 hours following completion of the last of 12 consecutive dialysis sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2010 (estimated)
- Study startNov 2016
- Primary completionMay 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HaemodialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hull
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- George E Smith, BSc MBBS MRCS, Principal investigator, Hull and East Yorkshire NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01163981
- Sponsor's protocol ID
- Access 5
- Status last verified
- Oct 2018
- First submitted
- 12 Jul 2010
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01163981
- Acronym / sponsor ID
- Access 5
- Conditions
- Haemodialysis
- Keywords
- duplex Ultrasound, Haemodialysis, Vascular Access
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of HullUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 16 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blind cannulation | No intervention | –Cannulation without guidance |
| Ultrasound guided cannulation | Experimental | Other: Use of ultrasound guidance in cannulationUltrasound guided cannulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Dialysis 3X per week
- Dialysing via 2 needles in fistula
- No deviation from routine dialysis protocol (additional or no heparin etc)
Key exclusion criteria (4 listed)
- Active or recent fistula infection/thrombosis/intervention in 6/52 of study
- Patient request
- Patient non compliance with study protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of ultrasound guidance in cannulationAlso: duplex ultrasoundUse of guidance with duplex ultrasound to complete cannulation of dialysis access | Other | Ultrasound guided cannulation |
Primary outcome
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
4 secondary outcomes
- Patient reported pain scores Patient reported anxiety and pain
Time frame: enrollment, two weeks and four weeks into trial
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
complications of needling
Time frame: Within 2 hours of completing each of the next 12 consecutive dialysis sessions
Referral for difficult needling during trial
Time frame: From enrollment to 24 hours following completion of the last of 12 consecutive dialysis sessions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George E Smith, BSc MBBS MRCS principal investigator
Hull and East Yorkshire NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of ultrasound guidance in cannulation in people with Haemodialysis, run by University of Hull at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to establish dialysis (time frame: Within an average of 5 minutes into each of the next 12 consecutive dialysis session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.