摘要：
Objective We tried to develop a reliable,stable and effective customized ECLS system through a well designed in vitro and in vivo study.Methods An in vitro test model of the ECLS system,mainly consisting of a pseudo-patient (a blood reservoir),bladder,oxygenator,pump tube (outer diameter:1/4 inch),roller pump and the heater,was built.Performances of the pump,monitors,and the heater were observed every day.The precision of the pump flow (pressure monitor or the heater) was compared with a transonic flow-meter (Medtronic ECMO system or thermometer).The monitors were tested to see if they could meet the requirements.Four healthy and two mild ARDS piglets were supported with the customized ECLS system for 24 hours.Hemodynamics,lung mechanics,gas change and hematological parameters of the piglets and performances of the machine were recorded.Agreement between the customized ECLS system and other devices including the transonic flow-meter,Medtronic ECMO system and thermometer was evaluated by the Bland-Altman method.Results The pump,the monitors,and the heater functioned well without accidently stopping working.The 95％ limits of agreement of pump flow,pre-pump pressure,post-pump pressure,post-membrane pressure,and temperature were (-0.04 L/min,0.03 L/min),(-3 mmHg,3 mmHg),(-5 mmHg,6 mmHg),(-6 mmHg,6 mmHg),(0.1 °C,0.3 °C).The pressure monitors and the bladder could alarm and stop the pump fast during a 100 times trail.The bubble detector could respond well (alarm and stop the pump) to 60 of the 100 bubbles injected into the circuit.The alarming temperature of the heater was (42.3±0.2) °C.The customized ECLS worked well without complications throughout the in vivo test.A temporary decrease of Cdyn and increase of A-aDO2 and OI were observed in healthy piglets while an escalating trend of Cdyn and a downtrend of A-aDO2 and OI in ARDS piglets.Mean arterial blood pressure of the piglets supported with the customized ECLS system maintained stable while the Hb and PLT decreased.Conclusion In vitro and in vivo test showed the pump,pressure monitors and the heater of the customized ECLS system functioned well,and the feasibility,safety and stability of the system were preliminarily verified from the cytosol of the cell to the lumen of the sarcoplasmic reticulum.%目的 通过离体和在体实验,评估一台定制体外生命支持系统的可行性、稳定性、安全性.方法 由储血罐(模拟患者)、储血囊、氧合器、内径1/4英寸(1英寸=2.54 cm)连接管、水箱等建立离体测试模型.每天记录滚轴泵、水箱工作情况,分别以超声流量仪、温度计检测滚轴泵流量、水箱温度读数是否精确.将压力监测系统与美敦力体外膜肺氧合(ECMO)系统对同样压力的测量结果进行比较,评估其准确性及稳定性.满足监测系统报警条件,观察报警及停泵情况.将定制系统应用于4头健康幼猪和2头轻度ARDS幼猪24 h,记录幼猪的血流动力学、呼吸力学、气体交换、血液学参数,并观察定制系统工作情况.定制系统与超声流量仪、温度计等之间的一致性评估采用Bland-Altman分析的方法.结果 滚轴泵、监测系统、水箱均运行稳定.泵流量、泵前压、泵后压、膜后压、温度测量结果的95％一致性界限分别为:(-0.04 L/min,0.03L/min)、(-3 mmHg,3 mmHg)、(-5mmHg,6mmHg)、(-6mmHg,6mmHg).泵前压、泵后压、膜后压、气泡监测、储血囊均进行了100次测试,压力监测及储血囊报警均灵敏,停泵迅速,气泡监测仅60次报警并停泵.水箱报警温度为(42.3±0.2)°C.在体实验中定制系统工作平稳,健康幼猪接入定制系统后顺应性(Cdyn)有一过性下降,肺泡-动脉氧分压差(A-aDO2)和氧合指数(OI)有一过性升高,而ARDS幼猪接入定制系统后Cdyn呈上升趋势,A-aDO2和OI呈下降趋势.幼猪接入定制系统后平均动脉压相对稳定,血红蛋白及血小板呈下降趋势.结论 离体及在体实验显示该定制系统的滚轴泵、压力监测系统、水箱性能较好,初步证实该系统具有一定的可行性、稳定性、安全性.
