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Trial registered on ANZCTR


Registration number
ACTRN12617001569392
Ethics application status
Approved
Date submitted
9/11/2017
Date registered
21/11/2017
Date last updated
6/11/2020
Date data sharing statement initially provided
24/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Use of ultrasound in cannulation of haemodialysis vascular access and affect on needle placement and cannulation success.
Scientific title
Point of care ultrasound-guided cannulation versus standard cannulation in haemodialysis. Affects on needle placement and cannulation success. A controlled random order crossover pilot and feasibility study.
Secondary ID [1] 293319 0
Nil known
Universal Trial Number (UTN)
U1111-1204-8151
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
end stage renal failure 305408 0
haemodialysis 305409 0
Arteriovenous fistula 305410 0
Condition category
Condition code
Renal and Urogenital 304689 304689 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will be undertaken over a 6 to 12 month period and will evaluate two conditions:
(1) Point of care ultrasound guided cannulation and (2) usual practice of blind cannulation, when applied by different nurses. Each patient will be exposed to each condition and each one of the 10 nurses will implement each condition on the 20 haemodialysis patients.. The crossover design (across conditions and nurses) controls for differences between individuals and differences in nurses skills. Essentially each individual within the study acts as his/her own control, thus decreasing the effect of factors such as: AVF diameter, AVF depth, AVF age, condition of skin, presence of aneurysm or false aneurysm, patient comorbidities, and patient age.

Point of care ultrasound is the use of a small portable ultrasound machine with a sterile probe cover, and using sterile gel. The ultrasound is used to first assess an appropriate cannualation area, then the probe is held in the non-dominant hand whilst the nurse cannulates and watches the needle progress into the vessel on the ultrasound screen.

After each successful cannulation static ultrasound images will be taken by a second person (not involved in the cannulation) in both transverse and longitudinal planes. The images will be saved to a removable disc, and will be printed for third party review.

A third person will be blinded to both the condition and the nurse. The will measure with a ruler the location of the needle relative to the right and left side of the vessel and the top and bottom of the vessel.

Patients will attend their usual haemodialysis session and prepare for haemodialysis as normal. The ultrasound guided cannulation sessions may take a little longer than the blind cannulation sessions due to machine set up. The patients will be given a short survey after each cannulation session to measure their satisfaction with the condition they received that day.

The study will also test the feasibility of conducting a controlled random order crossover trial for measurement of POC ultrasound guided cannulation versus usual practice by testing recruitment, retention, attrition, methods of data collection and will provide data on variability and effect sizes which will inform the development of a future larger multi-site trial.

The researcher will be in attendance to collect data and note intervention adherence.
There is no requirement for a wash out period for this study.
Intervention code [1] 299583 0
Treatment: Devices
Intervention code [2] 299623 0
Treatment: Other
Comparator / control treatment
Usual practice of 'blind' cannulation. Blind cannulation is when the cannulator does not use ultrasound to see in side the vessel and rely on their assessment skills of inspection, palpation and auscultation only.
Control group
Active

Outcomes
Primary outcome [1] 303910 0
Overall cannulation success on first attempt

Measured as '0' success or '1' miscannulation. A miscannulation is when the needle cannot be threaded and is required to be removed or the needle infiltrates the vessel wall and is required to be removed. Success is measured as the needle being inserted into the vessel without extravasation or requirement of removal.
Timepoint [1] 303910 0
Data will be collected by the researcher each haemodialysis session onto a data collection sheet each Thursday and Friday (pragmatic decision) for a period of 6 to 12 months.
Primary outcome [2] 303911 0
Accuracy of needle tip placement

Measured with ruler by third party (printed static ultrasound images) to record the location of the needle tip within the vessel.
Timepoint [2] 303911 0
Data will be collected each haemodialysis session onto a data collection sheet each Thursday and Friday (pragmatic decision) for a period of 6 to 12 months.
Primary outcome [3] 303969 0
Feasibility: Establishing the recruitment, retention, attrition, methods of data collection and analysis,
Timepoint [3] 303969 0
At the end of each phase the outcome of that phase will be assessed.
E.g.
Were the recruitment methods successful (email & information sessions)? Were recruitment targets met?
What were the retention rates? How can this be improved?
What were the attrition rates? Reasons for attrition?
Were the methods of data collection workable and could these collection methods be used in a multi-site trial?
Were the methods of data collection accurate and could these be applied to larger data samples in multi-site trials?
Secondary outcome [1] 340434 0
Number of extravasations


The number of times a needle pierces the lumen of the vessel during cannulation. E.g. how many times the nurse has to pull back on the needle and re-thread into the vessel.
Timepoint [1] 340434 0
Data will be collected each haemodialysis session via observation of the cannualation and counted on a data spreadsheet each Thursday and Friday (pragmatic decision) for a period of 6 to 12 months
Secondary outcome [2] 340435 0
Procedure time


This will be measured by the researcher observing the cannulation using a stop watch to time the procedure from tourniquet application to haemodialysis machine start.
Timepoint [2] 340435 0
Data will be collected each haemodialysis session onto a data collection sheet each Thursday and Friday (pragmatic decision) for a period of 6 to 12 months
Secondary outcome [3] 340436 0
Nurse cannulation experience versus outcomes (composite secondary outcome)

Number of years/months cannulation experience related to the numbers of success or failure with cannulation and needle tip position. The number of years of experience is collected via questionnaire at the beginning of the study then matched with the number of miscannulations and location of needle tip collected during the study.
Timepoint [3] 340436 0
End of the 6 to 12 month data collection period
Secondary outcome [4] 340437 0
Nurse point of care ultrasound experience versus outcomes

Number of years/months point of care ultrasound experience related to the numbers of success or failure with cannulation and needle tip position. The number of years of ultrasound experience is collected via questionnaire at the beginning of the study then matched with the number of miscannulations and location of needle tip collected during the study.
Timepoint [4] 340437 0
End of the 6 to 12 month data collection period
Secondary outcome [5] 340438 0
Patient perceptions of conditions


Patient perception of pain at end of each cannulation session. This will be assessed using a questionnaire at the end of each session with a 10 point Likert scale.
Timepoint [5] 340438 0
Data will be collected each haemodialysis session onto a data collection sheet each Thursday and Friday (pragmatic decision) for a period of 6 to 12 months

Eligibility
Key inclusion criteria
Patients receiving hemodialysis three or more times per week via a native artriovenous fistula
The arteriovenous fistula must be > than 2 months old
Patients cannulated with metal needles.

Nurses employed full or part time
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients who have arteriovenous fistula < 2 months old
Patients undertaking haemodialysis with an arteriovenous graft or central venous catheter
Patients who cannot give consent
Nurses who have not completed initial haemodialysis training

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2017
Actual
6/02/2018
Date of last participant enrolment
Anticipated
31/07/2019
Actual
1/03/2019
Date of last data collection
Anticipated
31/07/2019
Actual
7/12/2019
Sample size
Target
30
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 9376 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment postcode(s) [1] 18066 0
3220 - Geelong

Funding & Sponsors
Funding source category [1] 297943 0
Hospital
Name [1] 297943 0
Barwon Health
Country [1] 297943 0
Australia
Funding source category [2] 297998 0
University
Name [2] 297998 0
Deakin University
Country [2] 297998 0
Australia
Funding source category [3] 300473 0
Charities/Societies/Foundations
Name [3] 300473 0
Nurses Memorial Centre
Country [3] 300473 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Waterfront campus
1 Gheringhap st Geelong
Victoria, 3220
Country
Australia
Secondary sponsor category [1] 297014 0
Hospital
Name [1] 297014 0
Barwon Health
Address [1] 297014 0
40 Little Fyans st
South Geelong
Victoria, 3220
Country [1] 297014 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298989 0
Barwon Health Human Research Ethics Committee
Ethics committee address [1] 298989 0
Ethics committee country [1] 298989 0
Australia
Date submitted for ethics approval [1] 298989 0
18/08/2017
Approval date [1] 298989 0
02/11/2017
Ethics approval number [1] 298989 0
HREC/17/VICBH/69
Ethics committee name [2] 301275 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [2] 301275 0
Ethics committee country [2] 301275 0
Australia
Date submitted for ethics approval [2] 301275 0
22/11/2018
Approval date [2] 301275 0
04/12/2018
Ethics approval number [2] 301275 0
2017-367

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78910 0
Prof Alison Hutchinson
Address 78910 0
Chair in Nursing (Monash Health)
Deakin University
Burwood Campus
221 Burwood highway
Burwood, Victoria 3125
Country 78910 0
Australia
Phone 78910 0
+61 3 9244 6446
Fax 78910 0
Email 78910 0
alison.hutchinson@deakin.edu.au
Contact person for public queries
Name 78911 0
Monica Schoch
Address 78911 0
Deakin University
Waterfront Campus
1 Gheringhap st
Geelong, Victoria 3220
Country 78911 0
Australia
Phone 78911 0
+61 3 52278347
Fax 78911 0
Email 78911 0
monica.schoch@deakin.edu.au
Contact person for scientific queries
Name 78912 0
Alison Hutchinson
Address 78912 0
Chair in Nursing (Monash Health)
Deakin University
Burwood Campus
221 Burwood highway
Burwood Victoria 3125
Country 78912 0
Australia
Phone 78912 0
+61 3 9244 6446
Fax 78912 0
Email 78912 0
alison.hutchinson@deakin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Due to small patient numbers, confidentiality is a priority.


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.