Ultrasonography, DopplerNCT05373875
Comparison of Huntleigh Dopplex DMX Digital Doppler Arterial Waveform With the Gold Standard of Ultrasound Duplex Arterial Waveform
An observational study of Ultrasonography, Doppler and Peripheral Arterial Disease, run by University Hospitals Bristol and Weston NHS Foundation Trust at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ultrasonography, Doppler, Peripheral Arterial Disease
- What is being tested?
- Doppler ultrasound
- How many people
- 17 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Jan 2019to 3 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred to the Vascular Science department at University Hospitals Bristol and Weston NHS Foundation Trust ( Tertiary Care Centre)
Who may be able to join
- Patients referred to the Vascular Science department at University Hospitals Bristol and Weston NHS Foundation Trust for an ABPI or exercise ABPI.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals Bristol and Weston NHS Foundation Trust
Bristol, BS16 9hg
About this study
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.
Read the detailed description
A sample size of 30 patients is recommended for a pilot study to give a stable estimate of statistical parameters (mean and variance for example). Patients recruited for this study will be out patients referred for an ABPI or exercise ABPI.A participant information sheet will be sent to the patient with there invitation to book an appointment. The patient will be asked if they have read the information and if they wish to participate when they call to book an appointment. Written consent will be obtained on the day of their appointment and patients will have the opportunity to ask questions. Patients who have been admitted to hospital, have a known allergy to coupling gel, are unable to give consent, or 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. During the appointment, each patient will be in a supine position and an 8 MHz Doppler probe from the Huntleigh Dopplex will be placed on the posterior tibial and anterior tibial arteries at the ankle of both feet applying a 45-60° angle to the surface of the skin. Audible and visual waveform traces will be recorded in each vessel on the Huntleigh Dopplex. A linear ultrasound probe from a GE 9logic will be placed on the skin in the same position as the Huntleigh Dopplex probe. The optimised spectral Doppler trace and audible waveform will be recoded on a cine loop. All recordings will be collected by the primary researcher using the same handheld Doppler and model of ultrasound machine to avoid interoperable variability. Once duplex recordings have been obtained, the patient's appointment will continue as to the department's protocol for performing an ABPI or exercise ABPI and the patient will then be discharged.
Audible and visual traces from duplex and the Huntleigh will be downloaded. Vascular trainee's in the 1st, 2nd and 3rd years of the scientist training programme and senior vascular scientists will be instructed on predefined waveforms. Audible waveforms and visual traces from the Huntleigh Dopplex will be separated and ordered randomly using a random number generator. Clinicians will listen to waveform recordings, assess visual traces and will be asked to describe them and also determine if this signifies the presence or absence of disease. Results will be analysed using descriptive statistics.
Diagnostic measurements will be taken including pulsatility and resistive index will be calculated to assess for agreement or significant difference between measurements taken on the Huntleigh Dopplex and Duplex ultrasound.
- Being tested
- Doppler ultrasound
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doppler ultrasoundDiagnostic test
Doppler to listen and classify the arterial signal in the ankle and arm (Ankle brachial pressure index (ABPI))
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (1)
resistive and pulsatility indexes
Secondary outcomes are to calculate the resistive and pulsatility indexes from the Huntleigh handheld Dopplex and duplex ultrasound arterial waveforms and assess if they are sufficiently in agreement
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start11 Jan 2019
- Primary completion3 May 2019
- Study completion3 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultrasonography, DopplerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Bristol and Weston NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Teresa Robinson, Principal investigator, University Hospitals Bristol and Weston NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05373875
- Sponsor's protocol ID
- DT/2018/6670
- Status last verified
- Jul 2022
- First submitted
- 9 May 2022
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Huntleigh Dopplex DMX Digital Doppler Arterial Waveform With the Gold Standard of Ultrasound Duplex Arterial Waveform
- ClinicalTrials.gov ID
- NCT05373875
- Acronym / sponsor ID
- DT/2018/6670
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University Hospitals Bristol and Weston NHS Foundation TrustUniversity, hospital or other
- Study start
- 11 Jan 2019 (actual)
- Primary completion
- 3 May 2019 (actual)
- Study completion
- 3 May 2019 (actual)
- First posted
- 13 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A sample size of 30 patients is recommended for a pilot study to give a stable estimate of statistical parameters (mean and variance for example). Patients recruited for this study will be out patients referred for an ABPI or exercise ABPI.A participant information sheet will be sent to the patient with there invitation to book an appointment. The patient will be asked if they have read the information and if they wish to participate when they call to book an appointment. Written consent will be obtained on the day of their appointment and patients will have the opportunity to ask questions. Patients who have been admitted to hospital, have a known allergy to coupling gel, are unable to give consent, or 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. During the appointment, each patient will be in a supine position and an 8 MHz Doppler probe from the Huntleigh Dopplex will be placed on the posterior tibial and anterior tibial arteries at the ankle of both feet applying a 45-60° angle to the surface of the skin. Audible and visual waveform traces will be recorded in each vessel on the Huntleigh Dopplex. A linear ultrasound probe from a GE 9logic will be placed on the skin in the same position as the Huntleigh Dopplex probe. The optimised spectral Doppler trace and audible waveform will be recoded on a cine loop. All recordings will be collected by the primary researcher using the same handheld Doppler and model of ultrasound machine to avoid interoperable variability. Once duplex recordings have been obtained, the patient's appointment will continue as to the department's protocol for performing an ABPI or exercise ABPI and the patient will then be discharged.
Audible and visual traces from duplex and the Huntleigh will be downloaded. Vascular trainee's in the 1st, 2nd and 3rd years of the scientist training programme and senior vascular scientists will be instructed on predefined waveforms. Audible waveforms and visual traces from the Huntleigh Dopplex will be separated and ordered randomly using a random number generator. Clinicians will listen to waveform recordings, assess visual traces and will be asked to describe them and also determine if this signifies the presence or absence of disease. Results will be analysed using descriptive statistics.
Diagnostic measurements will be taken including pulsatility and resistive index will be calculated to assess for agreement or significant difference between measurements taken on the Huntleigh Dopplex and Duplex ultrasound.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to the Vascular Science department at University Hospitals Bristol and Weston NHS Foundation Trust ( Tertiary Care Centre)
Key inclusion criteria (1 listed)
- Patients referred to the Vascular Science department at University Hospitals Bristol and Weston NHS Foundation Trust for an ABPI or exercise ABPI.
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doppler ultrasoundDoppler to listen and classify the arterial signal in the ankle and arm (Ankle brachial pressure index (ABPI)) | Diagnostic test | – |
Primary outcome
Change in wavefrom
Time frame: 1 day
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 secondary outcome
resistive and pulsatility indexes
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teresa Robinson principal investigator
University Hospitals Bristol and Weston NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ultrasonography, Doppler and Peripheral Arterial Disease, run by University Hospitals Bristol and Weston NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in wavefrom (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2022.