Hull Royal Infirmary
Hull, East Yorkshire, HU3 2JZ, United Kingdom
NCT Number: NCT01163981
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Hull, East Yorkshire, HU3 2JZ, United Kingdom
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
a. Active or recent fistula infection/thrombosis/intervention in 6/52 of study
Withdrawal criteria:
Use of guidance with duplex ultrasound to complete cannulation of dialysis access
Other names: duplex ultrasound
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
Time frame: enrollment, two weeks and four weeks into trial
Patient reported pain scores and anxiety scores recorded by questionnaire
Time frame: Within an average of 5 minutes into each of the next 12 consecutive dialysis session
number of cannulation attempts required
Time frame: Within 2 hours of completing each of the next 12 consecutive dialysis sessions
record presence of any complications due to needle insertion
Time frame: From enrollment to 24 hours following completion of the last of 12 consecutive dialysis sessions
Referral for difficult needling to either senior nurse or to access clinic during trial
University of Hull
Other
A Randomised Controlled Trial of the Effectiveness of Ultrasound Guidance in Cannulation of Dialysis Arteriovenous Fistulas and Grafts in a University Hospital Dialysis Unit
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05128188
End Stage Renal Disease on Dialysis, Haemodialysis
Derby, United Kingdom
View Trial DetailsNCT05729997
Chronic Disease, Chronic Kidney Diseases
Valencia, Spain
View Trial DetailsNCT05280106
Citrate Reaction, Haemodialysis
Bangkok, Thailand
View Trial DetailsNCT02707757
Anaemia, Anemia
London, United Kingdom
View Trial Details