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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Jon Prosser
- Telefonní číslo: 01482 674703
- E-mail: jonathon.prosser@nhs.net
Studijní záloha kontaktů
- Jméno: Judith Long
- E-mail: judith.long3@nhs.net
Studijní místa
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Hull, Spojené království, HU3 2JZ
- Nábor
- Hull University Teaching Hospitals NHS Trust
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Kontakt:
- James Illingworth
- Telefonní číslo: 01482 461903
- E-mail: james.illingworth3@nhs.net
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
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
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: COHORT
- Časové perspektivy: CROSS_SECTIONAL
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
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 je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Diagnostic Accuracy
Časové okno: 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)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Validity assessed via correlation
Časové okno: 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
Časové okno: 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.
Časové okno: Data collected at enrolment (1 day)
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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.
Časové okno: 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
Časové okno: Data collected at point of enrolment (1 day)
|
VAS used to assess tolerability |
Data collected at point of enrolment (1 day)
|
Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- R4364
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