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研究生：	楊博凱 Yang, Po-Kai
論文名稱：	新式自動化科氏音血壓計於高風險心血管族群之準確度及量測可行性研究 Accuracy and Feasibility of a Novel Automated Korotkoff Sound-Based Blood Pressure Monitor in High-Risk Cardiovascular Patients
指導教授：	葉明龍 Yeh, Ming-Long
學位類別：	博士 Doctor
系所名稱：	工學院 - 生物醫學工程學系 Department of BioMedical Engineering
論文出版年：	2026
畢業學年度：	114
語文別：	英文
論文頁數：	89
中文關鍵詞：	血壓量測、科氏音、示波法血壓計、心房顫動、動脈硬化、自動化血壓計
外文關鍵詞：	blood pressure measurement, Korotkoff sounds, oscillometric blood pressure monitor, atrial fibrillation, arterial stiffness, automated blood pressure device
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精準的血壓量測，是心血管風險評估與治療決策的重要依據。示波法血壓計（Oscillo-BP）雖已普遍使用，但面對心律不整或動脈硬化等高風險心血管族群時，量測表現容易受到影響。本研究評估一款新型的自動化科氏音血壓計（Ksens-BP），此裝置以半導體壓阻式微振動感測器擷取動脈壁訊號，再透過預訓練模型自動推估收縮壓與舒張壓，期望在臨床上較難量測的族群中，也能得到接近聽診法的血壓數值。

本研究共收錄 197 位受試者，累計進行 891 次量測。扣除非儀器因素導致的失敗（人為操作疏失 3 次、嚴重顫抖 4 次）後，共 884 次量測納入可行性分析。在這 884 次量測中，Oscillo-BP 失敗 143 次（16.2%），Ksens-BP 的擷取錯誤則為 61 次（6.9%），其中有 6 次為兩套系統同時失敗。後續再以 178 位受試者、686 次成功量測進行一致性分析。以聽診法血壓為參考標準，Ksens-BP 在收縮壓與舒張壓的一致性相關係數皆優於 Oscillo-BP，平均絕對誤差也明顯較低。Oscillo-BP 在舒張壓上出現系統性低估的現象，Ksens-BP 則未見此情形。混合效應模型進一步顯示，男性是 Oscillo-BP 收縮壓相對高估的獨立預測因子，但在 Ksens-BP 上並未觀察到類似影響；而心房顫動則是示波法量測失敗的主要預測因子，調整後勝算比達 11.84。

在這類心血管共病較多的門診族群中，Ksens-BP 量到的血壓結果與聽診法更為一致，尤其在舒張壓一致性、量測穩定度，以及心房顫動患者的量測成功率上，都展現出明顯優勢。整體結果顯示，對這類病患而言，Ksens-BP 不論在技術或臨床層面，都是一項值得採用的替代方案。

Accurate blood pressure (BP) measurement is crucial for cardiovascular risk assessment and therapeutic decision-making. Although oscillometric BP monitors (Oscillo-BP) are widely used, their performance in high-risk cardiovascular populations may be compromised by arrhythmia and arterial stiffness, resulting in larger measurement discrepancies and higher failure rates. This study evaluated a novel automated Korotkoff sound-based BP monitor (Ksens-BP) that uses a semiconductor piezoresistive microvibration sensor to capture arterial wall signals and a deep-learning model to automatically estimate systolic and diastolic BP, aiming to achieve closer agreement with auscultatory BP than oscillometric measurement in clinically challenging cohorts.

A total of 197 participants were enrolled from a cardiovascular outpatient center, yielding 891 attempted measurements. After excluding non-device-related attempts (human operation error, n = 3; severe tremor, n = 4), 884 attempts were eligible for feasibility evaluation. Oscillo-BP failed in 143/884 attempts (16.2%), whereas Ksens-BP acquisition errors occurred in 61/884 attempts (6.9%), including 6 attempts with concurrent failures of both systems. Ultimately, 686 successful measurements from 178 participants were included in the agreement analysis. Using auscultatory BP as the reference standard, Ksens-BP demonstrated stronger agreement than Oscillo-BP, with higher concordance correlation coefficients for both systolic and diastolic BP. Ksens-BP achieved significantly smaller mean absolute errors for both pressure domains compared with Oscillo-BP. Oscillo-BP exhibited a systematic diastolic underestimation. Mixed-effects modeling identified male sex as an independent predictor of Oscillo-BP systolic overestimation, with no corresponding effect on Ksens-BP. Atrial fibrillation was the dominant predictor of oscillometric measurement failure, with an adjusted odds ratio of 11.84 at the attempt level.

In this cardiovascular outpatient cohort enriched with atherosclerotic comorbidities, Ksens-BP provided BP estimates with substantially closer agreement with auscultatory measurements than Oscillo-BP, with particular advantages in diastolic agreement, sex-independent measurement consistency, and measurement feasibility in atrial fibrillation. These results suggest that the Ksens-BP approach is a technically and clinically distinct alternative to oscillometry for a high cardiovascular-risk comorbidity group.

中文摘要 i
Abstract ii
誌謝 iv
Table of Contents vi
List of Tables ix
List of Figures x
List of Abbreviations xi
Introduction 1
1 Background 1
2 Oscillometric Method Principles and Limitations 4
2.1 Fundamental mechanisms 4
2.2 Systematic Limitations and Accuracy Concerns 5
2.3 Issues in Atherosclerotic Cardiovascular Disease 7
2.4 Specific Problems in Atrial Fibrillation Patients 8
3 Development Status of Automated K-Sound Devices 11
3.1 Sensor technology and K-Sound Acquisition 11
3.2 Algorithmic Approaches to K-Sound Detection and Interpretation 12
3.3 Key Challenges in Automated K-Sound BP Monitoring 14
4 Commercial Landscape of Automated Korotkoff-Sound Devices 16
4.1 Commercial devices and automation levels 16
4.2 Remaining challenges 18
5 Motivation and Objectives 21
6 Hypothesis 23
Materials and Methods 24
1 Study Design 24
2 Study Population 25
3 Instrumentation and Integrated Measurement Apparatus 26
3.1 Central Controller 26
3.2 K-Sensor 27
3.3 Ksens-BP Acquisition 27
3.4 Oscillometric Device Integration 30
3.5 Auscultatory BP 30
4 Experimental Protocol 31
5 Statistical Analysis 32
Results 33
1 Study Population 33
2 Agreement and Systematic Differences Between Devices 35
3 Factors Influencing Measurement Differences 40
4 Subgroup Analyses 42
5 Outlier Analyses 44
6 Measurement Failure Analysis 46
Discussion 49
1 Principal Findings 49
2 Mechanistic Basis of Ksens-BP Superiority 50
3 Systematic Diastolic Underestimation by Oscillometry 52
4 Sex-Related Variation in Oscillometric Systolic Error 54
5 Performance of Automated K-Sound Devices 56
6 Atrial Fibrillation as the Primary Driver of Oscillometric Failure 58
7 Subgroup Variation in Diastolic Agreement 60
8 Limitations 62
Conclusion 63
Future Directions 64
References 65
Appendix: Curriculum Vitae 73
                                    

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