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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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000281190
Acronym
HAVSE
Enrollment
74
Registered
2019-02-25
Start date
2019-04-01
Completion date
2025-02-28
Last updated
2023-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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).

Interventions

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

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.

Sponsors

Royal Perth Hospital
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 12, 2026