基于CDMA的远程心电监测系统的检测和临床应用
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摘要
目的了解该系统在不同状态下、不同环境中的工作性能;与临床使用的心电监测仪对比,评价二者稳定性、敏感性和检出率,探讨该系统的临床应用价值。
方法性能测试分别在静止状态、运动状态以及某些特殊环境中(地下室和实验室)中,按照国家发布的心电监测仪专业标准(YY91079-1999)中的规定,通过心率信号发生器和电压发生装置向监测仪输入模拟心电信号,检测该系统服务器软件心电波形显示的灵敏度、稳定度和精确度以及监测系统的心电异常报警功能。
临床研究于2007年12月和2008年3月入选60名受试者,分入静态监测组、动态监测组和远程监测组。根据随机数字表决定接受监测的先后顺序。监测中打印一份心电图,将获得心电图交由独立的心血管医生进行阅图,并测量基线漂移、QRS波振幅和时限、P波振幅和时限、T波振幅和时限、P-R间期、Q-T间期、ST段改变等指标。比较心电图基线的稳定性、心电波形的一致性、ST段改变检测的敏感性、心律失常的检出率等。
结果性能测试1.静止状态下,心电波形显示的标准灵敏度为10mm/mV,最大灵敏度为30mm/mV。基线无时间漂移和温度漂移;耐极化电压试验中,心电波形的振幅变化幅度为0.9%。心电波形振幅显示的精确度为1mV+0.1%:自发生心率异常到监测仪产生报警的时间间隔为4.0s,服务器的报警时间为24.2s;紧急求助时,自信号发出到服务器报警发生的时间为26.0s。
2.运动状态下,心电波形振幅显示的精确度为1mV+0.2%;其余指标测试结果与静止状态相同。
3.在实验室中测试时,基线的时间漂移为1mm,温度漂移为0.2mm/℃,其余指标测试结果与静止状态相同;在地下室中测试时,自发生心率异常到监测仪产生报警的时间间隔为4.3s,服务器的报警时间为35.1s;紧急求助时,自信号发出到服务器报警发生的时间为37.3S,其余指标测试结果与静止状态相同。
临床研究1.静态监测组,远程实时心电监测仪(下文简称远程监测仪)心电波形基线漂移为(0.00±0.00)mm,对照仪器为(1.00±1.92)mm,二者差异具有统计学意义(P=0.0004);两组心电图中,QRS波振幅和时限、P波振幅和时限、T波振幅和时限、P-R间期、Q-T间期、ST段改变等参数均无统计学差异(P＞0.05);远程心电监测仪共检出20名患者发生心律失常,自动报警准确率100%;监测心率与听诊心率无统计学差异。
2.动态监测组,活动状态下受试者心电波形基线漂移为(0.00±0.00)mm,安静状态下为(0.00±0.00)mm,二者差异无统计学意义(P=0.102);两组心电图中,QRS波振幅和时限、P波振幅和时限、T波振幅有和时限、P-R间期、Q-T间期、ST段等参数均无统计学差异(P＞0.05);监测心率与听诊心率无统计学差异。
3.远程监测组,远程监测时受试者心电波形基线漂移为(0.00±0.25)mm,近距离监测时(0.00±0.00)mm,二者差异无统计学意义(P=0.564)。两组心电图中,QRS波振幅和时限、P波振幅和时限、T波振幅有和时限、P-R间期、Q-T间期、ST段等参数均无统计学差异(P＞0.05)。
结论性能测试该监测系统在静止状态、运动状态下和某些特殊环境中的灵敏度、稳定度和精确度均优于国家心电监测仪专业标准(YY91079-1999)中的要求;当发生心电异常时,系统能够迅速自动提供报警,但在地下室中系统报警延时增加。
临床研究1.安静状态下,远程心电监测仪心电波形基线稳定性优于对照仪器;两组仪器心电波形一致;测试仪器对ST段改变检出的敏感性不低于对照仪器;能够检测出常见的心律失常;能够准确显示心率。
2.活动状态下,受试者心电波形完整、连续,心电波形基线漂移小于国家心电监测仪专业标准中的要求;心电波形与静息状态下心电波形一致;对ST段异常检出的敏感性不低于静态监测时;能够检测出常见的心律失常;能够准确显示心率。
3.远程监测时,受试者心电波形完整、连续,心电波形基线漂移小于国家心电监测仪专业标准中的要求;心电波形与近距离监测心电波形一致;对ST段异常检出的敏感性不低于近距离监测时;能够检测出常见的心律失常。
Objective: To test the performance of this remote electrocardiography monitoring system in different state and environment.
To contrast the detection rate, sensitivity and stability of a new kind of remote electrocardiography monitoring instrument and control instrument, then evaluating this instrument's clinical practice value.
Methods: Performance test: Inputting analog signals to the electrocardiogram monitoring instrument to check the sensitivity, accuracy, stability and alarm function of this monitoring system. This test is executed according to the standard of electrocardiogram monitor (YY91079-1999) in the condition of rest, kin estate and some special environment, such as basement or laboratory.
Clinical research: This research is a stochastic, cross-reference and blind trial. Total 60 subjects were admitted to this research. They were assigned in three different groups. Thirty subjects were received static monitoring, twenty subjects were received dynamic monitor, ten subjects were received remote monitor. These electrocardiograms which were printed during the monitoring were measured by an independent cardiovascular doctor to survey the baseline stability, profile uniformity, ST segment change sensitivity and heart rate monitor accuracy.
Results: Performance test: 1. In the static state, the standard sensitivity of this system is 10 mm/mV and the maximum sensitivity is 30 mm/mV. There is no baseline drift with the change of time and temperature. The change of swing is only 0.9% when inputting a polarizing voltage of 300mV. The accuracy of swing is lmV+0.1% when inputting a standard voltage of 1 mV.
2. In dynamic state, the accuracy of swing is 1mV+0.2% when inputting a standard voltage of 1 mV. The rest is the same as that of static test.
3. In laboratory, the baseline changed 1mm in the time drift test and changed 0.2 mm/℃in the temperature drift test; the other index is the same as that of static test. In basement, the time of alarm get long and the other index is the same as that of static test.
Clinical researcher: 1. In the rest state, the baseline drift of measuring instrument is (1.00±1.92) mm, and the control instrument is (0.00±0.00) mm, the results have statistically significant difference (P <0.01) . The electrocardiographic parameter of the two group , such as the swing and time of QRS and the change of ST segment, has no statistical difference (P>0.05) .
2. In dynamic group, there is no significant difference(P<0.01 )of the baseline drift of the two; The electrocardiographic parameter of the two group , such as the swing and time of QRS and the change of ST segment, has no statistical difference (P>0.05) .
3. In remote group, there is no significant difference (P<0.01) of the baseline drift of the two; The electrocardiographic parameter of the two group , such as the swing and time of QRS and the change of ST segment, has no statistical difference (P>0.05) .
Conclusions: Performance test The sensitivity, accuracy, stability is superior to the standard of electrocardiogram monitor (YY91079-1999) .The system could auto alarm when it receives the exceptional electrocardiosignal, but in the basement ,the time gets long.
Clinical researcher 1. In rest state, the baseline stability of measuring instrument and control instrument is lower than the standard of electrocardiogram monitor. The electrocardiogram wave is corresponding. The sensitivity of the change of ST segment of measuring instrument is not inferior to the control instrument. This system could find the usual arrhythmia and the accurate rate of automatic alarm is 100%
2. In dynamic state, the baseline stability of two group is lower than the standard of electrocardiogram monitor. The electrocardiogram wave is corresponding. The sensitivity of the change of ST segment of the two group is similar. This system could find the usual arrhythmia correctly.
3. In remote monitoring, the baseline stability of two group is lower than the standard of electrocardiogram monitor. The electrocardiogram wave is corresponding. The sensitivity of the change of ST segment of the two group is similar. This system could find the usual arrhythmia correctly.
方法性能测试分别在静止状态、运动状态以及某些特殊环境中(地下室和实验室)中,按照国家发布的心电监测仪专业标准(YY91079-1999)中的规定,通过心率信号发生器和电压发生装置向监测仪输入模拟心电信号,检测该系统服务器软件心电波形显示的灵敏度、稳定度和精确度以及监测系统的心电异常报警功能。
临床研究于2007年12月和2008年3月入选60名受试者,分入静态监测组、动态监测组和远程监测组。根据随机数字表决定接受监测的先后顺序。监测中打印一份心电图,将获得心电图交由独立的心血管医生进行阅图,并测量基线漂移、QRS波振幅和时限、P波振幅和时限、T波振幅和时限、P-R间期、Q-T间期、ST段改变等指标。比较心电图基线的稳定性、心电波形的一致性、ST段改变检测的敏感性、心律失常的检出率等。
结果性能测试1.静止状态下,心电波形显示的标准灵敏度为10mm/mV,最大灵敏度为30mm/mV。基线无时间漂移和温度漂移;耐极化电压试验中,心电波形的振幅变化幅度为0.9%。心电波形振幅显示的精确度为1mV+0.1%:自发生心率异常到监测仪产生报警的时间间隔为4.0s,服务器的报警时间为24.2s;紧急求助时,自信号发出到服务器报警发生的时间为26.0s。
2.运动状态下,心电波形振幅显示的精确度为1mV+0.2%;其余指标测试结果与静止状态相同。
3.在实验室中测试时,基线的时间漂移为1mm,温度漂移为0.2mm/℃,其余指标测试结果与静止状态相同;在地下室中测试时,自发生心率异常到监测仪产生报警的时间间隔为4.3s,服务器的报警时间为35.1s;紧急求助时,自信号发出到服务器报警发生的时间为37.3S,其余指标测试结果与静止状态相同。
临床研究1.静态监测组,远程实时心电监测仪(下文简称远程监测仪)心电波形基线漂移为(0.00±0.00)mm,对照仪器为(1.00±1.92)mm,二者差异具有统计学意义(P=0.0004);两组心电图中,QRS波振幅和时限、P波振幅和时限、T波振幅和时限、P-R间期、Q-T间期、ST段改变等参数均无统计学差异(P＞0.05);远程心电监测仪共检出20名患者发生心律失常,自动报警准确率100%;监测心率与听诊心率无统计学差异。
2.动态监测组,活动状态下受试者心电波形基线漂移为(0.00±0.00)mm,安静状态下为(0.00±0.00)mm,二者差异无统计学意义(P=0.102);两组心电图中,QRS波振幅和时限、P波振幅和时限、T波振幅有和时限、P-R间期、Q-T间期、ST段等参数均无统计学差异(P＞0.05);监测心率与听诊心率无统计学差异。
3.远程监测组,远程监测时受试者心电波形基线漂移为(0.00±0.25)mm,近距离监测时(0.00±0.00)mm,二者差异无统计学意义(P=0.564)。两组心电图中,QRS波振幅和时限、P波振幅和时限、T波振幅有和时限、P-R间期、Q-T间期、ST段等参数均无统计学差异(P＞0.05)。
结论性能测试该监测系统在静止状态、运动状态下和某些特殊环境中的灵敏度、稳定度和精确度均优于国家心电监测仪专业标准(YY91079-1999)中的要求;当发生心电异常时,系统能够迅速自动提供报警,但在地下室中系统报警延时增加。
临床研究1.安静状态下,远程心电监测仪心电波形基线稳定性优于对照仪器;两组仪器心电波形一致;测试仪器对ST段改变检出的敏感性不低于对照仪器;能够检测出常见的心律失常;能够准确显示心率。
2.活动状态下,受试者心电波形完整、连续,心电波形基线漂移小于国家心电监测仪专业标准中的要求;心电波形与静息状态下心电波形一致;对ST段异常检出的敏感性不低于静态监测时;能够检测出常见的心律失常;能够准确显示心率。
3.远程监测时,受试者心电波形完整、连续,心电波形基线漂移小于国家心电监测仪专业标准中的要求;心电波形与近距离监测心电波形一致;对ST段异常检出的敏感性不低于近距离监测时;能够检测出常见的心律失常。
Objective: To test the performance of this remote electrocardiography monitoring system in different state and environment.
To contrast the detection rate, sensitivity and stability of a new kind of remote electrocardiography monitoring instrument and control instrument, then evaluating this instrument's clinical practice value.
Methods: Performance test: Inputting analog signals to the electrocardiogram monitoring instrument to check the sensitivity, accuracy, stability and alarm function of this monitoring system. This test is executed according to the standard of electrocardiogram monitor (YY91079-1999) in the condition of rest, kin estate and some special environment, such as basement or laboratory.
Clinical research: This research is a stochastic, cross-reference and blind trial. Total 60 subjects were admitted to this research. They were assigned in three different groups. Thirty subjects were received static monitoring, twenty subjects were received dynamic monitor, ten subjects were received remote monitor. These electrocardiograms which were printed during the monitoring were measured by an independent cardiovascular doctor to survey the baseline stability, profile uniformity, ST segment change sensitivity and heart rate monitor accuracy.
Results: Performance test: 1. In the static state, the standard sensitivity of this system is 10 mm/mV and the maximum sensitivity is 30 mm/mV. There is no baseline drift with the change of time and temperature. The change of swing is only 0.9% when inputting a polarizing voltage of 300mV. The accuracy of swing is lmV+0.1% when inputting a standard voltage of 1 mV.
2. In dynamic state, the accuracy of swing is 1mV+0.2% when inputting a standard voltage of 1 mV. The rest is the same as that of static test.
3. In laboratory, the baseline changed 1mm in the time drift test and changed 0.2 mm/℃in the temperature drift test; the other index is the same as that of static test. In basement, the time of alarm get long and the other index is the same as that of static test.
Clinical researcher: 1. In the rest state, the baseline drift of measuring instrument is (1.00±1.92) mm, and the control instrument is (0.00±0.00) mm, the results have statistically significant difference (P <0.01) . The electrocardiographic parameter of the two group , such as the swing and time of QRS and the change of ST segment, has no statistical difference (P>0.05) .
2. In dynamic group, there is no significant difference(P<0.01 )of the baseline drift of the two; The electrocardiographic parameter of the two group , such as the swing and time of QRS and the change of ST segment, has no statistical difference (P>0.05) .
3. In remote group, there is no significant difference (P<0.01) of the baseline drift of the two; The electrocardiographic parameter of the two group , such as the swing and time of QRS and the change of ST segment, has no statistical difference (P>0.05) .
Conclusions: Performance test The sensitivity, accuracy, stability is superior to the standard of electrocardiogram monitor (YY91079-1999) .The system could auto alarm when it receives the exceptional electrocardiosignal, but in the basement ,the time gets long.
Clinical researcher 1. In rest state, the baseline stability of measuring instrument and control instrument is lower than the standard of electrocardiogram monitor. The electrocardiogram wave is corresponding. The sensitivity of the change of ST segment of measuring instrument is not inferior to the control instrument. This system could find the usual arrhythmia and the accurate rate of automatic alarm is 100%
2. In dynamic state, the baseline stability of two group is lower than the standard of electrocardiogram monitor. The electrocardiogram wave is corresponding. The sensitivity of the change of ST segment of the two group is similar. This system could find the usual arrhythmia correctly.
3. In remote monitoring, the baseline stability of two group is lower than the standard of electrocardiogram monitor. The electrocardiogram wave is corresponding. The sensitivity of the change of ST segment of the two group is similar. This system could find the usual arrhythmia correctly.
引文
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