||Assessment of the Reuse of Noninvasive Hemoglobin Sensors in Clinical Practice
||Department of BioMedical Engineering
貧血是身體紅血球細胞不足的狀態。以往貧血診斷方法是以侵入性抽血檢測來定量身體內血紅素數值。一項基於光體積變化描記圖技術的非侵襲性血色素測量儀被引入臨床作為診斷貧血的輔助工具。本研究評估重複使用非侵襲性血色素感測器臨床重複使用之變異。首先於模擬實驗中評估五種不同重複使用非侵襲性血色素感測器貼片之方法。比較初次使用貼片與重複使用貼片得到的光體積變化描記圖信號間的相關係數。然後於醫院抽血櫃台徵求已預訂進行抽血檢查的受試者共146人，進行非侵襲性血色素測量。使用經過修飾或未經修飾的重複使用感測器貼片進行檢查，比較非侵襲血色素值與侵襲性血色素值之間的誤差與準確性。評估非侵襲性血色素感測器於診斷貧血的敏感性與特異性。於模擬試驗中，五種重複使用貼片的方式與初次使用的貼片測量值均與侵襲血色素值有相當程度的誤差 (大於2g/dl)。比較初次使用與重複使用貼片的得到的光體積變化描記圖信號間相關係數達0.95以上。於臨床測試中， A組74名受試者直接以重複使用的貼片受測，B組72名受試者使用經切開保護貼修飾的感測器貼片受測。當定義血色素值小於12g/dl為貧血狀態時，於A組非侵襲性血色素診斷貧血的敏感性為76.9% ，特異性為87.5%。於B組診斷診斷貧血的敏感性為71.4% ，特異性為94.1%。當定義貧血為血色素值小於10g/d時，整體非侵襲性血色素的專一性更高達99.2%。整體非侵襲性血色素讀值與傳統血色素測定成高度相關性，斯皮爾曼相關係數為0.776, p值小於0.01。於A組非侵襲性血色素精度(單標準差)為1.06g/dl, B組為1.01g/dl，數值一致性於兩組均過寬。非侵襲性血色素誤差容易發生在男性受測者與真實血色素較高的受測者上(12.7 [11.4-14.0] vs. 15.1 [11.4-15.5], p<0.001)。當真實血色素介於10~14g/dl時平均誤差最小。由於此項檢查的高度專一使得非侵襲性血色素測定可以更容易確立貧血診斷。
Anemia is a disease state of reduced red blood cell concentration. Its routine diagnosis method is invasive phlebotomy that measures the amount of hemoglobin in the blood sample. Currently, a commercially available device (Masimo Radical-7 Pulse CO-Oximetry system, Masimo, Irvine, CA) basing on multiple wavelength photoplethysmography may be applied instead for non-invasive hemoglobin (SpHb) measurement. The variations of reuse of the disposable sensor patch with and without modification are investigated in this study. Firstly, five ways of the sensor patch modifications are employed in a simulation study. The signal correlation coefficient between the first-used sensor patch and reused sensor patch is computed for comparison. Then, 146 subjects with informed consents are recruited for clinical tests. The bias, the precision, and the sensitivity/specificity for anemia diagnosis are compared. In the simulation study, a large biases in SpHb measurements among five groups are found, even with a new SpHb patch (>2g/dl). The correlation coefficient between the first-used SpHb patch and the reused SpHb patch is above 0.95. In the clinical study, there are 74 subjects in group A for sensor patch reuse without modification, and 72 subjects in group B for sensor patch reuse with a window of plastic film. The sensitivity for anemia defined as less than 12g/dl are 76.9% (group A) and 71.4% (group B), respectively. While, the specificity are 87.5% (group A) and 94.1% (group B), respectively. When the anemia defined as less than 10g/dl, the overall specificity of SpHb is up to 99.2%. The SpHb is correlated well with the actual hemoglobin level (Spearman's rho=0.776, p<0.01). The precision (1 standard deviation of difference) is 1.06 g/dl in group A and 1.01 g/dl in group B. The limits of agreement are broad in the both methods. The male subjects show a large SpHb bias with a high baseline hemoglobin (12.7 [11.4-14.0] vs. 15.1 [11.4-15.5], p<0.001). The mean bias is modest when the hemoglobin ranges between 10~14g/dl. The high specificity of SpHb implies this device has the great potential for ruling in the diagnosis of anemia.
List of Tables V
List of Figures VI
Chapter 1 Introduction 1
1.1 Importance of hemoglobin 1
1.2 Noninvasive hemoglobin (SpHb) measurement 1
1.3 The drawbacks of SpHb 3
1.4 The aim of this study 4
Chapter 2 Materials and Methods 5
2.1 Research framework 5
2.2 Part I: The simulation study 6
2.3 Part II: The clinical study 9
Chapter 3 Results and Discussion 13
3.1 Results of the simulation study 13
3.2 The results of the clinical study 16
3.3 Discussion 23
3.4 Limitations 30
Chapter 4 Conclusions and Prospects 31
4.1 Conclusions 31
4.2 Prospects 31
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