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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Jon Prosser
- Numéro de téléphone: 01482 674703
- E-mail: jonathon.prosser@nhs.net
Sauvegarde des contacts de l'étude
- Nom: Judith Long
- E-mail: judith.long3@nhs.net
Lieux d'étude
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Hull, Royaume-Uni, HU3 2JZ
- Recrutement
- Hull University Teaching Hospitals NHS Trust
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Contact:
- James Illingworth
- Numéro de téléphone: 01482 461903
- E-mail: james.illingworth3@nhs.net
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
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
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: CROSS_SECTIONAL
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Diagnostic Accuracy
Délai: 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)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Validity assessed via correlation
Délai: 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)
|
|
Diagnostic performance
Délai: Data collected at enrolment (1 day)
|
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.
Délai: 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.
Délai: 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
Délai: Data collected at point of enrolment (1 day)
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VAS used to assess tolerability |
Data collected at point of enrolment (1 day)
|
Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- R4364
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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