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Validation of Ankle-Barchial Index Measurement Using a Multi-Cuff Oscillometric Device Versus the Standard Doppler Method.

Not Applicable
Conditions
Peripheral arterial disease
Registration Number
JPRN-UMIN000037436
Lead Sponsor
ara Medical University
Brief Summary

In total, 118 patients were evaluated. The prevalence of Doppler ABI 0.90 was 45.8%. Taking the Dop-ABI as the reference, the sensitivity, specificity, accuracy, positive and negative predictive values of oscillometric ABI during the first measurement by the first observer were 89.1%, 94.4%, 94.1%, 91.8%, and 92.4%, respectively.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
120
Inclusion Criteria

Not provided

Exclusion Criteria

Cardiac arrhythmia: Atrial fibrillation, atrial flutter, frequent supra and ventricular ectopic beats Patients under dialysis

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Sensitivity, specificity, PPV, NPV, and Prevalence of the oscillometric method to detect a low (<0.90) ABI were determined by usual formula, taking the Doppler method as the reference.
Secondary Outcome Measures
NameTimeMethod
The intra and interobserver variability of measurements were first assessed by the determination of the intraclass correlation coefficient (ICC) of agreement for each method. In order to determine methods with the best reproducibility (the lowest variability), 95% CI of these ICCs were then compared. A second analysis of intra- and inter-observer reproducibility were made by the Bland and Altman's method.
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