Abstract：
BACKGROUND: We determined if the heart rate (HR) monitoring performance of a wireless and nonadhesive belt is non-inferior compared to standard electrocardiography (ECG). Secondary objective was to explore the belt\'s respiratory rate (RR) monitoring performance compared to chest impedance (CI).
METHODS: In this multicenter non-inferiority trial, preterm and term infants were simultaneously monitored with the belt and conventional ECG/CI for 24 h. HR monitoring performance was estimated with the HR difference and ability to detect cardiac events compared to the ECG, and the incidence of HR-data loss per second. These estimations were statistically compared to prespecified margins to confirm equivalence/non-inferiority. Exploratory RR analyses estimated the RR trend difference and ability to detect apnea/tachypnea compared to CI, and the incidence of RR-data loss per second.
RESULTS: Thirty-nine infants were included. HR monitoring with the belt was non-inferior to the ECG with a mean HR difference of 0.03 beats per minute (bpm) (standard error [SE] = 0.02) (95% limits of agreement [LoA]: [-5 to 5] bpm) (p < 0.001). Second, sensitivity and positive predictive value (PPV) for cardiac event detection were 94.0% (SE = 0.5%) and 92.6% (SE = 0.6%), respectively (p ≤ 0.001). Third, the incidence of HR-data loss was 2.1% (SE = 0.4%) per second (p < 0.05). The exploratory analyses of RR showed moderate trend agreement with a mean RR-difference of 3.7 breaths/min (SE = 0.8) (LoA: [-12 to 19] breaths/min), but low sensitivities and PPV\'s for apnea/tachypnea detection. The incidence of RR-data loss was 2.2% (SE = 0.4%) per second.
CONCLUSIONS: The nonadhesive, wireless belt showed non-inferior HR monitoring and a moderate agreement in RR trend compared to ECG/CI. Future research on apnea/tachypnea detection is required.
METHODS: In this multicenter non-inferiority trial, preterm and term infants were simultaneously monitored with the belt and conventional ECG/CI for 24 h. HR monitoring performance was estimated with the HR difference and ability to detect cardiac events compared to the ECG, and the incidence of HR-data loss per second. These estimations were statistically compared to prespecified margins to confirm equivalence/non-inferiority. Exploratory RR analyses estimated the RR trend difference and ability to detect apnea/tachypnea compared to CI, and the incidence of RR-data loss per second.
RESULTS: Thirty-nine infants were included. HR monitoring with the belt was non-inferior to the ECG with a mean HR difference of 0.03 beats per minute (bpm) (standard error [SE] = 0.02) (95% limits of agreement [LoA]: [-5 to 5] bpm) (p < 0.001). Second, sensitivity and positive predictive value (PPV) for cardiac event detection were 94.0% (SE = 0.5%) and 92.6% (SE = 0.6%), respectively (p ≤ 0.001). Third, the incidence of HR-data loss was 2.1% (SE = 0.4%) per second (p < 0.05). The exploratory analyses of RR showed moderate trend agreement with a mean RR-difference of 3.7 breaths/min (SE = 0.8) (LoA: [-12 to 19] breaths/min), but low sensitivities and PPV\'s for apnea/tachypnea detection. The incidence of RR-data loss was 2.2% (SE = 0.4%) per second.
CONCLUSIONS: The nonadhesive, wireless belt showed non-inferior HR monitoring and a moderate agreement in RR trend compared to ECG/CI. Future research on apnea/tachypnea detection is required.
摘要：
背景：我们确定与标准心电图（ECG）相比，无线非粘附带的心率（HR）监测性能是否不差。次要目的是探讨与胸部阻抗（CI）相比，腰带的呼吸频率（RR）监测性能。
方法：在这项多中心非劣效性试验中，同时监测早产和足月儿24小时和常规ECG/CI。与ECG相比，用HR差异和检测心脏事件的能力来估计HR监测性能。和每秒HR数据丢失的发生率。将这些估计与预先指定的边缘进行统计比较，以确认等效/非劣效性。探索性RR分析估计了与CI相比的RR趋势差异和检测呼吸暂停/呼吸急促的能力，以及每秒RR数据丢失的发生率。
结果：纳入39名婴儿。用皮带进行的HR监测不劣于ECG，平均HR差异为每分钟0.03次（bpm）（标准误差[SE]=0.02）（95％的一致性极限[LoA]：[-5至5]bpm）（p<0.001）。第二,心脏事件检测的灵敏度和阳性预测值(PPV)分别为94.0%(SE=0.5%)和92.6%(SE=0.6%),分别(p≤0.001)。第三，HR数据丢失的发生率为2.1%(SE=0.4%)/秒(p<0.05).RR的探索性分析显示出中等趋势一致，平均RR差异为3.7次呼吸/分钟（SE=0.8）（LoA：[-12至19]次呼吸/分钟），但对呼吸暂停/呼吸急促检测的敏感性和PPV较低。RR数据丢失的发生率为每秒2.2％（SE=0.4％）。
结论：非粘附性，与ECG/CI相比，无线腰带显示HR监测不差，RR趋势中度一致。需要对呼吸暂停/呼吸急促检测进行未来的研究。
方法：在这项多中心非劣效性试验中，同时监测早产和足月儿24小时和常规ECG/CI。与ECG相比，用HR差异和检测心脏事件的能力来估计HR监测性能。和每秒HR数据丢失的发生率。将这些估计与预先指定的边缘进行统计比较，以确认等效/非劣效性。探索性RR分析估计了与CI相比的RR趋势差异和检测呼吸暂停/呼吸急促的能力，以及每秒RR数据丢失的发生率。
结果：纳入39名婴儿。用皮带进行的HR监测不劣于ECG，平均HR差异为每分钟0.03次（bpm）（标准误差[SE]=0.02）（95％的一致性极限[LoA]：[-5至5]bpm）（p<0.001）。第二,心脏事件检测的灵敏度和阳性预测值(PPV)分别为94.0%(SE=0.5%)和92.6%(SE=0.6%),分别(p≤0.001)。第三，HR数据丢失的发生率为2.1%(SE=0.4%)/秒(p<0.05).RR的探索性分析显示出中等趋势一致，平均RR差异为3.7次呼吸/分钟（SE=0.8）（LoA：[-12至19]次呼吸/分钟），但对呼吸暂停/呼吸急促检测的敏感性和PPV较低。RR数据丢失的发生率为每秒2.2％（SE=0.4％）。
结论：非粘附性，与ECG/CI相比，无线腰带显示HR监测不差，RR趋势中度一致。需要对呼吸暂停/呼吸急促检测进行未来的研究。
