Reliability validation of harmonic analysis of blood pressure wave measurement and its clinical application, taking tea consumption for example

• Main Authors: Chi-Wei Chang, 張琦偉
• Other Authors: Hsiao-Wen Chung
• Format: Others
• Language: zh-TW
• Published: 2017
• Online Access: http://ndltd.ncl.edu.tw/handle/8jf524

博士 === 國立臺灣大學 === 生醫電子與資訊學研究所 === 105 === Pulse wave analysis (PWM) has been studied for many decades and many pressure measuring instruments were developed for this purpose. However, there was no complete assessment system and standard protocol to quantify the intrinsic reliability, intra-observer repeatability, and inter-observer reproducibility for clinical evaluation of a pressure measuring instrument. Therefore, there are three main purposes of this study. First, we aimed to assess intrinsic reliabilities of devices for pulse wave measurement using artificial pulse generator. Second, this study was aimed to establish a standard protocol for clinical test and to quantitatively assess the reliability of pulse wave analysis system, including intra-observer reliability, and inter-observer reliability. We used Pulse wave analyzer TD01C (MII-ANN Technology, Taiwan) as an example to validate the feasibility of previous two purposes. Third, we performed a clinical test of tea consumption to demonstrate pulse wave analysis could be useful in monitoring the circulation and to evaluate the effect of functional food or health product. In the first step of the study, we build up an artificial pulse generator system to create a periodic pulse wave and DP103pressure transducer (Validyne, CA, USA) was used to test the stability of the periodic output. We then used the pulse generator system for evaluating the test–re-test and inter-device reliability of the TD01C system. We used harmonic analysis (HA), the coefficient of variation (CV), intra-class correlation coefficient (ICC) and Bland-Altman plot to determine the degree of reliability of the TD01C system. The artificial pulse generator system was proved stable to evaluate intrinsic reliabilities of devices for PWM (ICCs>0.95, p<0.001). TD01C was proved reliable for repeated measurements (ICCs of test–re-test reliability>0.95, p<0.001; CVs all<3%). The report confirmed the feasibility of intrinsic reliability assessment of devices for PWM using an artificial pulse generator system. The second step of the study, we used the TD01C system to perform a clinical test on healthy subjects and tested TD01C’s intra-observer and inter-observer reliability in PWM of the radial pulse wave. We conducted assessments using HA and investigated the stabilities of harmonics in successive measurements. ICC and Bland-Altman plot was used to verify the level of the stabilities. Twenty-two subjects (mean age 45±14 years; 14 males and 8 females) were enrolled for both the reliability assessments of intra-observer and of inter-observer. The report presented excellent repeatability (Intraclass correlation coefficients, ICCs>0.9, p<0.001) for intra-observer assessment and high reproducibility (ICCs range from 0.83-0.96, p<0.001) for inter-observer assessment. In the Bland-Altman plots, more than 90% of harmonics fell within two standard deviations of the mean difference. Consequently, PWM using TD01C system is a feasible and reliable method to assess hemodynamic characteristic in a clinical test. Third, the study performed a clinical test to investigate the effect of tea consumption on brain circulation. The radial pulse wave was measured by the TD01C system and blood pressure was measured with blood pressure monitor HEM-6051 (Omron, Japan). We used HA to evaluated circulation change. The report confirmed that consumption of Lipton black tea, Sanxia black tea, and Sanxia green tea all increased higher harmonic components (from sixth to tenth harmonic components of radial blood pulse). We conclude that tea could increase cerebral blood flow and thus the possible mechanism of tea-mediated neuroprotective effect is not only by the neuroprotective compounds of tea but also by increasing the brain perfusion. In summary, the TD01C measuring system, which was validated by the phantom test and clinical test, reached the reliability for clinical interpretation. In addition to its ability to identify the different characteristics for different status of the arterial system, there is great potential to apply the TD01C system on the cardiovascular research and is worthy to carry out more investigation.