Efficacy and safety of domestic disposable pressure sensor:a prospective,self-parallel controlled double-center clinical study
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 pres-sure 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 Uni-versity 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(T1),at 1 min after the last intravenous an-esthetic drug injection(T2)and at tracheal intubation completion(T3).Additionally,the performance,safety indicators of the product,and success rate of arterial blood collection were recorded.Results At different time points T1,T2 and T3,the the consistency rates of systolic blood pressure measured by two sensors were both 100.0％.The consistency rate of diastolic blood pressure at T1 measured by the two kinds of sensors was 99.2％,which at T2 and T3 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,PO2 and PCO2 reached 100.0％,94.5％and 99.2％respectively.Conclusion The effectiveness,accuracy and safety of domestically produced dis-posable invasive blood pressure sensor meet clinical needs.
万方数据
维普
