Automated ABPI in Peripheral Arterial Disease a Pilot Study (AUTO-PAD)
Assessing the Diagnostic Accuracy of AUTOmated Ankle-Brachial Pressure Index Devices Across the Spectrum of Peripheral Arterial Disease (AUTO-PAD)- A Pilot Study
The aim of this pilot study is to investigate the diagnostic accuracy of two automated ABPI devices across the spectrum of PAD (asymptomatic PAD, suspected symptomatic PAD [IC; including mild moderate and severe IC based on the Rutherford classification (21) and CLTI] and post-bypass surveillance). A second aim is to assess their useability and tolerability through semi-structured interviews with patients and clinicians. This means the research will be split into two workstreams.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Jon Prosser
- Numer telefonu: 01482 674703
- E-mail: jonathon.prosser@nhs.net
Kopia zapasowa kontaktu do badania
- Nazwa: Judith Long
- E-mail: judith.long3@nhs.net
Lokalizacje studiów
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Hull, Zjednoczone Królestwo, HU3 2JZ
- Rekrutacyjny
- Hull University Teaching Hospitals NHS Trust
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Kontakt:
- James Illingworth
- Numer telefonu: 01482 461903
- E-mail: james.illingworth3@nhs.net
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
Group 1: Asymptomatic PAD:
Patients identified by the GP (PIC sites). Records screened to identify 'at risk' of PAD with >1 cardiovascular disease risk factor
Group 2: Suspected symptomatic PAD:
2a. Patients with suspected IC referred to dedicated nurse-led claudication clinic.
Group 2b. Patients with suspected CLTI referred to dedicated urgent vascular (HOT) clinic.
Group 3: Patients undergoing surveillance seen in dedicated clinics by vascular scientists
Opis
Inclusion Criteria:
Group 1: Asymptomatic
- Adults aged 18 and over
- At risk of PAD with ≥1 cardiovascular risk factor
- No previous diagnosis of PAD
- English speaking and able to understand test protocols
Group 2a: Suspected PAD (intermittent claudication)
- Adults aged 18 and over
- Referred and booked into the nurse-led claudication clinic due to signs/symptoms in keeping with suspected intermittent claudication
- English speaking and able to understand test protocols
Group 2b: Suspected PAD (CLTI)
- Adults aged 18 and over
- Referred and booked into the vascular HOT clinic due to signs/symptoms in keeping with suspected CLTI
- English speaking and able to understand test protocols
Group 3: Post-bypass surveillance
- Adults aged 18 and over
- History of lower limb bypass surgery, enrolled in and attending the local surveillance programme
- English speaking and able to understand test protocols
Exclusion Criteria:
- Patients who are unable to provide informed consent
- Recent (≤4 weeks) lower-limb surgery
- Ulcers, casts or bandages that cannot or should not be compressed
- Patients who have had a therapeutic intervention (stent or graft) which extends to the ankle
- Patients with known or suspected acute deep vein thrombosis (DVT) or superficial thrombophlebitis
- Marked oedema in one or both feet
- Inability to tolerate a supine position
- Patients with spasms or tremors of any kind
- Arm arteriovenous fistula
- Inability to cooperate due to impaired cognition
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Modele obserwacyjne: COHORT
- Perspektywy czasowe: CROSS_SECTIONAL
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
|
Group 1 Asymptomatic
Participants with one or more CVD risk factors |
The MESI mTablet uses 3CUFFTM technology to detect pulse waveforms to assess ABPI. This involves placing a blood pressure cuff on all 4 limbs at the same time. The two arm cuffs then inflate and simultaneously measure the blood pressure in both brachial arteries. The cuff with the highest systolic pressure than reinflates with both the ankle cuffs simultaneously. The ABPI is then calculated and displayed on the tablet. A ratio of <0.9 will indicate the presence of PAD. The BlueDop device is a cuffless device which comprises an egg-shaped handheld probe component and an output monitor device. The device measures mean arterial blood pressure through an algorithm. Simply, it calculates the average blood pressure based on the normal rise and fall of pressure during each heartbeat. The device then automatically generates an ankle-brachial pressure index and a corresponding traffic-light classification for each lower-limb artery, based on waveform. This output is interpreted using table 2 below. Essentially an ABPI of 0.8-1.0 with a biphasic or triphasic waveform indicates no disease whereas an ABPI <0.8 and / or a monophasic/non-specific waveform indicates the presence of PAD. |
|
Group 2a Suspected PAD (intermittent claudication)
Partcipants presenting with Suspected PAD (intermittent claudication) |
The MESI mTablet uses 3CUFFTM technology to detect pulse waveforms to assess ABPI. This involves placing a blood pressure cuff on all 4 limbs at the same time. The two arm cuffs then inflate and simultaneously measure the blood pressure in both brachial arteries. The cuff with the highest systolic pressure than reinflates with both the ankle cuffs simultaneously. The ABPI is then calculated and displayed on the tablet. A ratio of <0.9 will indicate the presence of PAD. The BlueDop device is a cuffless device which comprises an egg-shaped handheld probe component and an output monitor device. The device measures mean arterial blood pressure through an algorithm. Simply, it calculates the average blood pressure based on the normal rise and fall of pressure during each heartbeat. The device then automatically generates an ankle-brachial pressure index and a corresponding traffic-light classification for each lower-limb artery, based on waveform. This output is interpreted using table 2 below. Essentially an ABPI of 0.8-1.0 with a biphasic or triphasic waveform indicates no disease whereas an ABPI <0.8 and / or a monophasic/non-specific waveform indicates the presence of PAD. |
|
Group 2b Suspected PAD (CLTI)
Participants presenting with tissue loss or rest pain |
The MESI mTablet uses 3CUFFTM technology to detect pulse waveforms to assess ABPI. This involves placing a blood pressure cuff on all 4 limbs at the same time. The two arm cuffs then inflate and simultaneously measure the blood pressure in both brachial arteries. The cuff with the highest systolic pressure than reinflates with both the ankle cuffs simultaneously. The ABPI is then calculated and displayed on the tablet. A ratio of <0.9 will indicate the presence of PAD. The BlueDop device is a cuffless device which comprises an egg-shaped handheld probe component and an output monitor device. The device measures mean arterial blood pressure through an algorithm. Simply, it calculates the average blood pressure based on the normal rise and fall of pressure during each heartbeat. The device then automatically generates an ankle-brachial pressure index and a corresponding traffic-light classification for each lower-limb artery, based on waveform. This output is interpreted using table 2 below. Essentially an ABPI of 0.8-1.0 with a biphasic or triphasic waveform indicates no disease whereas an ABPI <0.8 and / or a monophasic/non-specific waveform indicates the presence of PAD. |
|
Group 3 Post-bypass surveillance
Participants presenting for post-bypass surveillance |
The MESI mTablet uses 3CUFFTM technology to detect pulse waveforms to assess ABPI. This involves placing a blood pressure cuff on all 4 limbs at the same time. The two arm cuffs then inflate and simultaneously measure the blood pressure in both brachial arteries. The cuff with the highest systolic pressure than reinflates with both the ankle cuffs simultaneously. The ABPI is then calculated and displayed on the tablet. A ratio of <0.9 will indicate the presence of PAD. The BlueDop device is a cuffless device which comprises an egg-shaped handheld probe component and an output monitor device. The device measures mean arterial blood pressure through an algorithm. Simply, it calculates the average blood pressure based on the normal rise and fall of pressure during each heartbeat. The device then automatically generates an ankle-brachial pressure index and a corresponding traffic-light classification for each lower-limb artery, based on waveform. This output is interpreted using table 2 below. Essentially an ABPI of 0.8-1.0 with a biphasic or triphasic waveform indicates no disease whereas an ABPI <0.8 and / or a monophasic/non-specific waveform indicates the presence of PAD. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Diagnostic Accuracy
Ramy czasowe: From enrolment to the end of treatment (1 day)
|
Diagnostic accuracy assessed via sensitivity, specificity, positive predictor value (PPV) and negative predictor value (NPV). |
From enrolment to the end of treatment (1 day)
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Validity assessed via correlation
Ramy czasowe: Data collected at enrolment (1 day)
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Diagnostic performance assessed via area under the receiver operating characteristic (AUROC) curve and the assessment time difference, assessed via measurement of the time taken to perform each automated ABPI assessment and the manual ABPI assessment. |
Data collected at enrolment (1 day)
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Diagnostic performance
Ramy czasowe: Data collected at enrolment (1 day)
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Assessed via area under the receiver operating characteristic (AUROC) curve. |
Data collected at enrolment (1 day)
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Time taken to perform each automated ABPI assessment and the manual ABPI assessment.
Ramy czasowe: Data collected at enrolment (1 day)
|
Time taken to perform each assessment in seconds |
Data collected at enrolment (1 day)
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Qualitative Workstream - Assessment of usability and tolerability of automated devices.
Ramy czasowe: Within the 2 year recruitment period
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Semi structured interviews analysed using thematic analysis |
Within the 2 year recruitment period
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Visual Analogue Scale (VAS) score of 0-10
Ramy czasowe: Data collected at point of enrolment (1 day)
|
VAS used to assess tolerability |
Data collected at point of enrolment (1 day)
|
Współpracownicy i badacze
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- R4364
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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