PDF(Pubmed)
Abstract：
BACKGROUND: Recently, a ring-type cuffless blood pressure (BP) measuring device has been developed. This study was a prospective, single arm, first-in-human pivotal trial to evaluate accuracy of BP measurement by the new device.
METHODS: The ring-type smart wearable monitoring device measures photoplethysmography signals from the proximal phalanx and transmits the data wirelessly to a connected smartphone. For the BP comparison, a cuff was worn on the arm to check the reference BP by auscultatory method, while the test device was worn on the finger of the opposite arm to measure BP simultaneously. Measurements were repeated for up to three sets each on the left and right arms. The primary outcome measure was mean difference and standard deviation of BP differences between the test device and the reference readings.
RESULTS: We obtained 526 sets of systolic BP (SBP) and 513 sets of diastolic BP (DBP) from 89 subjects, with ranges of 80 to 175 mmHg and 43 to 122 mmHg for SBP and DBP, respectively. In sample-wise comparison, the mean difference between the test device and the reference was 0.16 ± 5.90 mmHg (95% limits of agreement [LOA], -11.41, 11.72) in SBP and -0.07 ± 4.68 (95% LOA, -9.26, 9.10) in DBP. The test device showed a strong correlation with the reference for SBP (r = 0.94, P < 0.001) and DBP (r = 0.95, P < 0.001). There were consistent results in subject-wise comparison.
CONCLUSIONS: The new ring-type BP measuring device showed a good correlation for SBP and DBP with minimal bias compared with an auscultatory method.
METHODS: The ring-type smart wearable monitoring device measures photoplethysmography signals from the proximal phalanx and transmits the data wirelessly to a connected smartphone. For the BP comparison, a cuff was worn on the arm to check the reference BP by auscultatory method, while the test device was worn on the finger of the opposite arm to measure BP simultaneously. Measurements were repeated for up to three sets each on the left and right arms. The primary outcome measure was mean difference and standard deviation of BP differences between the test device and the reference readings.
RESULTS: We obtained 526 sets of systolic BP (SBP) and 513 sets of diastolic BP (DBP) from 89 subjects, with ranges of 80 to 175 mmHg and 43 to 122 mmHg for SBP and DBP, respectively. In sample-wise comparison, the mean difference between the test device and the reference was 0.16 ± 5.90 mmHg (95% limits of agreement [LOA], -11.41, 11.72) in SBP and -0.07 ± 4.68 (95% LOA, -9.26, 9.10) in DBP. The test device showed a strong correlation with the reference for SBP (r = 0.94, P < 0.001) and DBP (r = 0.95, P < 0.001). There were consistent results in subject-wise comparison.
CONCLUSIONS: The new ring-type BP measuring device showed a good correlation for SBP and DBP with minimal bias compared with an auscultatory method.
摘要：
背景：最近，已开发出环形无袖带血压（BP）测量装置。这项研究是前瞻性的，单臂,首次在人的关键试验，以评估新设备的BP测量的准确性。
方法：环型智能可穿戴监测设备测量来自近端指骨的光电体积描记信号，并将数据无线传输到连接的智能手机。对于BP比较，在手臂上佩戴袖带以通过听诊方法检查参考BP，同时将测试设备戴在相反手臂的手指上，以同时测量BP。在左臂和右臂上重复测量多达三组。主要结果测量是测试设备和参考读数之间的BP差异的平均差和标准偏差。
结果：我们从89名受试者中获得526组收缩压（SBP）和513组舒张压（DBP），SBP和DBP的范围为80至175mmHg和43至122mmHg，分别。在样本比较中，试验装置与参照物之间的平均差为0.16±5.90mmHg(95%一致限度[LOA],-11.41，11.72）在SBP和-0.07±4.68（95%LOA，-9.26，9.10）DBP。试验装置显示出与SBP(r=0.94,P<0.001)和DBP(r=0.95,P<0.001)的参考具有很强的相关性。在与受试者的比较中存在一致的结果。
结论：与听诊法相比，新型环形BP测量装置显示出SBP和DBP的良好相关性，偏差最小。
方法：环型智能可穿戴监测设备测量来自近端指骨的光电体积描记信号，并将数据无线传输到连接的智能手机。对于BP比较，在手臂上佩戴袖带以通过听诊方法检查参考BP，同时将测试设备戴在相反手臂的手指上，以同时测量BP。在左臂和右臂上重复测量多达三组。主要结果测量是测试设备和参考读数之间的BP差异的平均差和标准偏差。
结果：我们从89名受试者中获得526组收缩压（SBP）和513组舒张压（DBP），SBP和DBP的范围为80至175mmHg和43至122mmHg，分别。在样本比较中，试验装置与参照物之间的平均差为0.16±5.90mmHg(95%一致限度[LOA],-11.41，11.72）在SBP和-0.07±4.68（95%LOA，-9.26，9.10）DBP。试验装置显示出与SBP(r=0.94,P<0.001)和DBP(r=0.95,P<0.001)的参考具有很强的相关性。在与受试者的比较中存在一致的结果。
结论：与听诊法相比，新型环形BP测量装置显示出SBP和DBP的良好相关性，偏差最小。
