无线可穿戴设备连续监测胸腔镜肺癌切除术后患者基本生命体征的前瞻性自身对照研究

Continuous vital signs monitoring using wireless wearable devices in patients after video-assisted thoracoscopic surgery for lung cancer:A prospective self-control study

目的 探究利用无线可穿戴监护设备连续监测胸腔镜肺癌切除术后患者基本生命体征的可靠性和安全性。方法 前瞻性纳入四川大学华西医院2023年5-8月行胸腔镜肺癌切除手术患者,术后同时利用无线可穿戴和传统有线设备监测患者的基本生命体征。分别利用Spearman相关分析、配对样本t检验和比值BlandAltman法检验两种设备测得的监测数据的相关性、差异性和一致性;通过计算无线设备12 h内有效监护率,检验其连续监护的可靠性。结果 共纳入20例患者,其中女15例、男5例,平均年龄(46.20±11.52)岁。两种设备采集的基本生命体征数据均显著相关(P<0.001),其中呼吸频率和血氧饱和度数据差异无统计学意义(P>0.05),而无线设备测得的心率略低(■=-0.307±1.073,P<0.001),血压(■=1.259±5.354,P<0.001)和体温(■=0.115±0.231,P<0.001)略高;两种设备采集的心率、呼吸频率、血氧饱和度、血压及体温的比值均值分别为:0.996、1.004、1.000、1.014、1.003,各指标的95%一致性界限(limits of agreement,LoA)和95%LoA的95%置信区间均在临床可接受范围内;各指标12 h内有效监护率均>98%。结论 利用无线可穿戴监护设备对胸腔镜肺癌切除术后患者的生命体征进行连续监测具有较高的准确性和可靠性,为后续大规模临床应用和深入研究提供了安全保障。

Objective To explore the reliability and safety of continuous monitoring of vital signs in patients using wireless wearable monitoring devices after video-assisted thoracoscopic surgery(VATS)for lung cancer.Methods The patients undergoing VATS for lung cancer in West China Hospital,Sichuan University from May to August 2023 were prospectively enrolled.Both wireless wearable and traditional wired devices were used to monitor the vital signs of patients after surgery.Spearman correlation analysis,paired sample t test and ratio Bland-Altman method were used to test the correlation,difference and consistency of monitoring data measured by the two devices.The effective monitoring rate of the wireless wearable device within 12 hours was calculated to test the reliability of its continuous monitoring.Results A total of 20 patients were enrolled,including 15 females and 5 males with an average age of 46.20±11.52 years.Data collected by the two monitoring devices were significantly correlated(P<0.001).Respiratory rate and blood oxygen saturation data collected by the two devices showed no statistical difference(P>0.05),while heart rate measured by wireless wearable device was slightly lower(=−0.307±1.073,P<0.001),and the blood pressure(=1.259±5.354,P<0.001)and body temperature(d¯=0.115±0.231,P<0.001)were slightly higher.The mean ratios of heart rate,respiratory rate,blood oxygen saturation,blood pressure and body temperature collected by the two devices were 0.996,1.004,1.000,1.014,and 1.003,respectively.The 95%limits of agreement(LoA)and 95%confidence interval of 95%LoA of each indicator were within the clinically acceptable limit.The effective monitoring rate of each vital signs within 12 hours was above 98%.Conclusion The wireless wearable device has a high accuracy and reliability for continuous monitoring vital signs of patients after VATS for lung cancer,which provides a security guarantee for subsequent large-scale clinical application and further research.