Reliability assessment for pulse wave measurement using artificial pulse generator

Abstract

This study aimed to assess intrinsic reliabilities of devices for pulse wave measurement (PWM). An artificial pulse generator system was constructed to create a periodic pulse wave. The stability of the periodic output was tested by the DP103 pressure transducer. The pulse generator system was then used to evaluate the TD01C system. Test-re-test and inter-device reliability assessments were conducted on the TD01C system. First, 11 harmonic components of the pulse wave were calculated using Fourier series analysis. For each harmonic component, coefficient of variation (CV), intra-class correlation coefficient (ICC) and Bland-Altman plot were used to determine the degree of reliability of the TD01C system. In addition, device exclusion criteria were pre-specified to improve consistency of devices. The artificial pulse generator system was stable to evaluate intrinsic reliabilities of devices for PWM (ICCs > 0.95, p < 0.001). TD01C was reliable for repeated measurements (ICCs of test-re-test reliability > 0.95, p < 0.001; CVs all < 3%). Device exclusion criteria successfully excluded the device with defect; therefore, the criteria reduced inter-device CVs of harmonics and improved consistency of the selected devices for all harmonic components. This study confirmed the feasibility of intrinsic reliability assessment of devices for PWM using an artificial pulse generator system. Moreover, potential novel findings on the assessment combined with device exclusion criteria could be a useful method to select the measuring devices and to evaluate the qualities of them in PWM.

Development of a Standard Protocol for the Harmonic Analysis of Radial Pulse Wave and Assessing Its Reliability in Healthy Humans

“…One is the coefficient of variation of harmonic amplitude among pulses within one measurement (WCV \documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{upgreek} \usepackage{mathrsfs} \setlength{\oddsidemargin}{-69pt} \begin{document} }{}$_{\mathrm {cn}})$ \end{document} . Since the WCV \documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{upgreek} \usepackage{mathrsfs} \setlength{\oddsidemargin}{-69pt} \begin{document} }{}$_{\mathrm {cn}}\text{s}$ \end{document} were less than 3% using TD01C in the phantom study [43] , the WCV \documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{upgreek} \usepackage{mathrsfs} \setlength{\oddsidemargin}{-69pt} \begin{document} }{}$_{\mathrm {cn}}\text{s}$ \end{document} beyond 3% revealed that the variation were partially introduced by the arterial system of the subject. The previous reports had shown that this within-measurement variation of the harmonics reflected the stage of severity in dying patients [56] , [57] .…”

“…TD01C should operate within working condition: \documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{upgreek} \usepackage{mathrsfs} \setlength{\oddsidemargin}{-69pt} \begin{document} }{}$0\sim 2.5$ \end{document} PSI (peak to peak pressure), 23°C-35°C, and 15% to 85% Relative humidity. The instrument reliability of TD01C had been validated before the measurements were performed [43] .…”

Risk assessment of macrovascular and microvascular events in patients with type 2 diabetes by analyzing the amplitude variation of the fourth harmonic component of radial pulse wave

“…All subjects underwent radial pulse wave measurements and recorded C4CV values at baseline. Radial pulse waves were noninvasively measured by medical‐grade devices that had been found to be highly reproducible (Chang and Wang ), and the intra‐observer and inter‐observer reliabilities met the criteria for medical interpretation (Portney and Watkins ; Chang et al ). The standard operating procedures for environmental temperature control and radial pressure wave measurement were as described in previous studies (Chang et al , ).…”

Radial Pulse Spectrum Analysis as Risk Markers to Improve the Risk Stratification of Silent Myocardial Ischemia in Type 2 Diabetic Patients

“…Each subject was asked to lie down in a supine position and rest for 5 minutes before the measurement. The pulse pressure was then recorded on the left-hand radial artery with a pulse wave analyzer TD01C (MII-ANN Technology, Taiwan), which has proven its intrinsic reliability using the artificial pulse generator [27] . The intra-observer and inter-observer reliabilities of TD01C were also demonstrated in the clinical study [28] .…”