国产一次性压力传感器的有效性及安全性:一项前瞻性、自身平行对照双中心临床研究  

Efficacy and safety of domestic disposable pressure sensor:a prospective,self-parallel controlled double-center clinical study *

作　　者：秦巧玲 方亮 罗亚东 喻梦仙 QIN Qiaoling;FANG Liang;LUO Yadong;YU Mengxian(Chongqing Kanghua Zhonglian Cardiovascular Disease Hospital,Chongqing 400025,China;Second Affiliated Hospital of Army Medical University,Chongqing 400037,China;Chongqing Municipal Public Health Medical Treatment Center,Chongqing 400036,China)

机构地区：[1]重庆康华众联心血管病医院,重庆400025 [2]陆军军医大学第二附属医院,重庆400037 [3]重庆市公共卫生医疗救治中心,重庆400036

出　　处：《重庆医学》2024年第22期3380-3384,共5页Chongqing Medical Journal

基　　金：重庆市科卫联合科研项目(2020FYYX092);重庆市技术创新与应用发展专项重点项目(CSTC2021jscx-gksb-N0007)。

摘　　要：目的评估国产一次性压力监测传感器临床应用的有效性与安全性。方法采用自身平行对照,选取2021年1-3月在重庆康华众联心血管病医院和陆军军医大学第二附属医院两家协作医院麻醉科手术室需同时进行有创动脉血压及中心静脉压监测的心血管相关疾病的手术患者128例为研究对象,同时采用两种一次性压力传感器持续监测并记录麻醉诱导前(T_(1))、最后一个静脉麻醉药注射完1 min(T_(2))、气管插管完成时(T_(3))的有创动脉血压及中心静脉压,同时记录产品的性能、安全性指标及动脉采血成功率。结果在不同时间点T_(1)、T_(2)、T_(3),两种传感器测得的收缩压的一致率均为100.0%。两种传感器测量舒张压在T_(1)的一致率为99.2%,T_(2)和T_(3)一致率为100.0%;两种传感器测量中心静脉压在3个时间点的一致率均为100.0%。相关系数显示,两种传感器在收缩压、舒张压和中心静脉压的测量中保持高度一致性。动脉血气分析指标pH值、血氧分压(PO_(2))、血二氧化碳分压(PCO_(2))的一致率分别达到100.0%、94.5%、99.2%。结论国产一次性压力传感器其有效性、准确性、安全性符合临床需要。Objective To evaluate the effectiveness and safety of domestically manufactured disposable pressure monitoring sensor in clinical application.Methods The self-parallel control was adopted.A total of 128 patients undergoing surgery for cardiovascular related disease requiring both invasive arterial blood pressure and central venous pressure simultaneously monitoring in the two collaborating hospitals of Chongqing Kanghua Zhonglian Cardiovascular Disease Hospital and the Second Affiliated Hospital of Army Medical University from January to March 2021 were selected as the study subjects.The two kinds of disposable invasive pressure sensors were simultaneously utilized for continuous monitoring and recording invasive arterial blood pressure and central venous pressure prior to anesthesia induction(T_(1)),at 1 min after the last intravenous anesthetic drug injection(T_(2))and at tracheal intubation completion(T_(3)).Additionally,the performance,safety indicators of the product,and success rate of arterial blood collection were recorded.Results At different time points T_(1),T_(2) and T_(3),the the consistency rates of systolic blood pressure measured by two sensors were both 100.0%.The consistency rate of diastolic blood pressure at T_(1) measured by the two kinds of sensors was 99.2%,which at T_(2) and T_(3) was 100.0%.The consistency rates of central venous pressure at 3 time points by the two kinds of sensors were both 100.0%.The correlation coefficient showed that the two kinds of sensors kept the high consistency in measuring systolic blood pressure,diastolic blood pressure and central venous pressure.The concordance rates of arterial blood gas analysis indexes pH,PO_(2) and PCO_(2) reached 100.0%,94.5%and 99.2%respectively.Conclusion The effectiveness,accuracy and safety of domestically produced disposable invasive blood pressure sensor meet clinical needs.

关 键 词：有创血压 收缩压 舒张压 中心静脉压 动脉血气 传感器 

分 类 号：R612[医药卫生—外科学]