ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12619000281190

Ethics application status

Approved

Date submitted

20/02/2019

Date registered

25/02/2019

Date last updated

24/02/2023

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

Secondary ID [1]

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)

Vascular access

Condition category

Condition code

Renal and Urogenital

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]

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]

Sensitivity and specificity of accelerometer spectral changes vs concurrent Doppler flow rates for the diagnosis of failing and well-functioning AV fistulae

Timepoint [1]

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]

None

Timepoint [1]

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

Sex

Both males and females

Can healthy volunteers participate?

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

Recruiting

Date of first participant enrolment

Anticipated

1/04/2019

Actual

1/04/2019

Date of last participant enrolment

Anticipated

28/02/2025

Actual

Date of last data collection

Anticipated

28/02/2025

Actual

Sample size

Target

114

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Royal Perth Hospital - Perth

Recruitment postcode(s) [1]

6000 - Perth

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of WA

Address [1]

35 Stirling Hwy Perth WA 6009

Country [1]

Australia

Primary sponsor type

Hospital

Name

Royal Perth Hospital

Address

197 Wellington St, Perth WA 6000

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Perth Hospital Human Research Ethics Committee

Ethics committee address [1]

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]

Australia

Date submitted for ethics approval [1]

30/10/2017

Approval date [1]

29/01/2018

Ethics approval number [1]

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

Dr Mark Thomas

Address

Royal Perth Hospital, Level 6 A Block, 197, Victoria Square, Perth WA 6000

Country

Australia

Phone

+61 8 9224 2244

Fax

Mark.Thomas@health.wa.gov.au

Contact person for public queries

Name

Mark Thomas

Address

Royal Perth Hospital, Level 6 A Block, 197, Victoria Square, Perth WA 6000

Country

Australia

Phone

+61 8 9224 2244

Fax

Mark.Thomas@health.wa.gov.au

Contact person for scientific queries

Name

Patrice Mwipatayi

Address

Royal Perth Hospital
Service 4, Vascular
197 Wellington St, Perth WA 6000

Country

Australia

Phone

+61 89386 9588

Fax

BMwipatayi@health.wa.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
1386	Study protocol					376941-(Uploaded-20-02-2019-18-10-28)-Study-related document.docx

Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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