Comparison of Huntleigh Dopplex DMX Digital Doppler Arterial Waveform With the Gold Standard of Ultrasound Duplex Arterial Waveform

NCT05373875 | Completed

• 1 other identifier: DT/2018/6670
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

NICE guidelines recommend an Ankle brachial pressure index (ABPI) as the primary assessment tool for patients presenting with symptoms or are at a high risk of developing peripheral arterial disease (PAD). An ABPI is typically performed using a hand-held Doppler to listen and classify the arterial signal in the ankle and arm and the systolic pressure is taken in each to create a ratio of the pressure in the ankle to the arm. New Huntleigh Dopplex DMX Digital Dopplers within the vascular department have an arterial waveform display to help interpretation of the audible signal. This study aims to compare the audible and visual waveform traces on the Huntleigh Dopplex with the gold standard of ultrasound duplex to assess the accuracy of the trace using diagnostic measurements and the ability of clinicians to correctly identify audible and visual waveforms.

Conditions

Ultrasonography, Doppler; Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• Change in wavefrom

  Primary outcomes are the change in waveform identified and diagnosis of the presence or absence of disease once the visual waveform trace and assess they are sufficiently in agreement.

  1 day

Secondary Outcomes (1)

• resistive and pulsatility indexes

  1 day

Interventions

Doppler ultrasound DIAGNOSTIC_TEST

Doppler to listen and classify the arterial signal in the ankle and arm (Ankle brachial pressure index (ABPI))

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred to the Vascular Science department at University Hospitals Bristol and Weston NHS Foundation Trust ( Tertiary Care Centre)

You may qualify if:

• Patients referred to the Vascular Science department at University Hospitals Bristol and Weston NHS Foundation Trust for an ABPI or exercise ABPI.

You may not qualify if:

• Those who have been admitted to hospital,
• Under the age of 18,
• Known allergy to coupling gel,
• Unable to give consent,
• Pedal pulses are not detectable will be excluded from this study,
• Persons interpreting waveforms will be excluded if they reported having any hearing or visual impairment.
• Full Set of Project Data IRAS Version 5.9.1 10

Sponsors & Collaborators

• University Hospitals Bristol and Weston NHS Foundation Trust: lead

Study Sites (1)

University Hospitals Bristol and Weston NHS Foundation Trust

Bristol, BS16 9hg, United Kingdom

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Ultrasonography, Doppler

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Teresa Robinson

  University Hospitals Bristol and Weston NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 13, 2022
• Study Start: January 11, 2019
• Primary Completion: May 3, 2019
• Study Completion: May 3, 2019
• Last Updated: July 29, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)