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Trial registered on ANZCTR


Registration number
ACTRN12619000281190p
Ethics application status
Submitted, not yet approved
Date submitted
20/02/2019
Date registered
25/02/2019
Date last updated
25/02/2019
Date data sharing statement initially provided
25/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Haemodialysis Access and their Vibration and Sound Evaluation (HAVSE): assessing the vascular access (AV fistula) of kidney failure patients on haemodialysis using a simple skin sensor compared to formal Doppler examination or clinical examination
Scientific title
Haemodialysis Access and their Vibration and Sound Evaluation (HAVSE): assessing the vascular access (AV fistula) of kidney failure patients on haemodialysis using a simple skin sensor compared to formal Doppler examination or clinical examination
Secondary ID [1] 297363 0
nil yet
Universal Trial Number (UTN)
Trial acronym
HAVSE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End Stage Kidney Disease (ESKD) 311495 0
Vascular access 311496 0
Condition category
Condition code
Renal and Urogenital 310133 310133 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Medical students and an electronics engineer will measure the vibrations and bruit from turbulent flow in AVFs with an accelerometer and microphone (phonoangiography) placed upon the skin overlying a patient's AVF.

The procedure takes 3-5 minutes, recording flow patterns at a standardised series of sites (bottom, middle, top, needling sites, any area of perceived narrowing), according to checklist, and recorded on a standard AVF diagram.

No patient preparation is required. The examination will be performed when patients present to the dialysis unit as soon as convenient (usually within 1-2 weeks) after a concurrent formal Doppler examination in Royal Perth Hospital Radiology Department, and physical examination by a vascular access nurse practitioner.
Intervention code [1] 313618 0
Early detection / Screening
Comparator / control treatment
Physical examination of an AV fistula assessing the palpable thrill and audible bruit is performed by a nurse practitioner trained in assessing vascular access, with no patient preparation required, and recorded on a standard AVF diagram. This takes 3-5 minutes, and can occur in the dialysis unit, or at the Vascular Access outpatient clinic.

Doppler ultrasound of an AV fistula quantifies the blood flow rates and anatomy of the attached artery and vein, and is performed by a trained sonographer in the Radiology Dept of Royal Perth Hospital, recorded on a standard AVF diagram, taking 30-45 minutes.
Control group
Active

Outcomes
Primary outcome [1] 319029 0
Sensitivity and specificity of accelerometer spectral changes vs concurrent Doppler flow rates for the diagnosis of failing and well-functioning AV fistulae
Timepoint [1] 319029 0
Each patient's AV fistula will be assessed once by accelerometer (at time of dialysis) and compared to a concurrent formal Doppler examination
Secondary outcome [1] 366917 0
None
Timepoint [1] 366917 0
None

Eligibility
Key inclusion criteria
Patient has an AVF located anywhere on the forearm or upper arm, plus.

ESKD patients on regular dialysis, or

Pre-dialysis patients with newly-formed unused fistula
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those with:
- Previous procedures in the same limb
- Infection
- Pseudoaneurysms
- Movement in the arm i.e. Parkinson’s
- Cuts/rashes or other skin abnormalities
- Prosthetic AV fistulae

Study design
Purpose of the study
Diagnosis
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
Feasibility will be based on several parameters, including:
1. The correlation of frequencies of measured thrills and bruits with stenosis and thrombosis, which will be assessed using linear regression. It is expected that there will be an upwards shift in the frequency spectrum representing stenosis and thrombosis (i.e. poorly functioning AVFs) compared to normally functioning AVFs. The correlation between the different positions and the results obtained will also be assessed in a similar manner.
2. Initially amplitude over time will be obtained from the data. This will be converted to amplitude over frequency (Y and X axis respectively) which will be accomplished via a fast Fourier transform (FFT).

Similar to what is available in the literature, amplitudes of signals from failing AVFs are significantly different to those of normally functioning AVFs. Our study will include an amplitude-based analysis in an attempt to demonstrate this phenomenon.
3. Receiver operating characteristic curve will be used to characterise the sensitivity and specificity of the technique. This will in turn be compared to the sensitivity and specificity of the Doppler ultrasound, which is the current clinical gold standard for AVF surveillance.
The coefficient of variation will be used to assess the intra-measurement reliability of our technique.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 13136 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 25677 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 301927 0
University
Name [1] 301927 0
University of WA
Address [1] 301927 0
35 Stirling Hwy Perth WA 6009
Country [1] 301927 0
Australia
Primary sponsor type
Hospital
Name
Royal Perth Hospital
Address
197 Wellington St, Perth WA 6000
Country
Australia
Secondary sponsor category [1] 301685 0
Commercial sector/Industry
Name [1] 301685 0
Nex Designs
Address [1] 301685 0
2/6 Hamersley Street, Cottesloe, 6011 WA
Country [1] 301685 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 302613 0
Royal Perth Hospital Human Research Ethics Committee
Ethics committee address [1] 302613 0
Research Ethics & Governance Unit
East Metropolitan Health Service
Level 2, Kirkman House, Royal Perth Hospital, 10 Murray St, Perth WA 6000
Ethics committee country [1] 302613 0
Australia
Date submitted for ethics approval [1] 302613 0
30/10/2017
Approval date [1] 302613 0
Ethics approval number [1] 302613 0
RGS0000000396

Summary
Brief summary
Patients with kidney failure on haemodialysis machines depend on a well-functioning surgically-created enlarged blood vessel in their arm, known as an arterio-venous fistula (AVF). These AVF can develop narrowings, which may progress to complete closure and failure, creating a surgical emergency. Every dialysis, the patient and their nurse check that the fistula is well-functioning by simple physical examination: i.e. can they feel a strong vibration and pulse; can they hear a loud noise with a stethoscope? If concerned, then a patient is referred for a formal Doppler study appointment by a trained technician, using a specialised machine.

This study aims to assess whether a simple electronic skin sensor known as an accelerometer (similar to a "FitBit") can detect narrowings inside the AV fistula, by comparing the accelerometer signal waveforms with a concurrent formal Doppler study.

We aim to study 60 patients with a range of well- and poorly-functioning AVF's to establish whether the technique is feasible and reliable (i.e. sensitive and specific).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90822 0
Dr Patrik Tosenovsky
Address 90822 0
Royal Perth Hospital
Service 4, Vascular
197 Wellington St, Perth WA 6000
Country 90822 0
Australia
Phone 90822 0
+61 892212191
Fax 90822 0
Email 90822 0
patrik.tosenovsky@health.wa.gov.au
Contact person for public queries
Name 90823 0
Dr Patrik Tosenovsky
Address 90823 0
Royal Perth Hospital
Service 4, Vascular
197 Wellington St, Perth WA 6000
Country 90823 0
Australia
Phone 90823 0
+61 892212191
Fax 90823 0
Email 90823 0
patrik.tosenovsky@health.wa.gov.au
Contact person for scientific queries
Name 90824 0
Dr Patrik Tosenovsky
Address 90824 0
Royal Perth Hospital
Service 4, Vascular
197 Wellington St, Perth WA 6000
Country 90824 0
Australia
Phone 90824 0
+61 892212191
Fax 90824 0
Email 90824 0
patrik.tosenovsky@health.wa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a pilot study to assess feasibility of the technique. Following these results, the IPD of future studies will be made available.
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 1386 0
Study protocol
Citation [1] 1386 0
Link [1] 1386 0
Email [1] 1386 0
Other [1] 1386 0
Summary results
No Results