新型螺旋导流集成式膜式氧合器安全性及有效性评价--多中心随机对照临床研究

Clinical study to evaluate the safety and effectiveness of a new spiral flow inte⁃grated membrane oxygenator:a multicenter randomized controlled trial

目的以进口膜式氧合器为对照,评价新型螺旋导流集成式膜式氧合器用于心肺转流(CPB)心脏外科手术的安全性和有效性。方法4家中心随机对照研究,最终入组160例受试者,159例(99.4%)受试者完成试验(试验组80例,对照组79例)。两组均于CPB开始前(T1)、升主动脉阻断后降温最低鼻咽温(31.5℃±1.5)℃(T2)、CPB结束前(麻醉恢复呼吸前)(T3)、CPB手术结束后24h内(T4)四个时点采集动脉血,测定血气分析、血常规、游离血红蛋白等,评价膜式氧合器有效性指标和安全性指标。主要有效性评价指标为产品的达标率。安全性评价包括多个指标。结果①两组产品达标率无显著性差异(P=1.000);②试验期间均未发生器械缺陷。所有受试者试验期间均未发生微栓塞及低氧血症;③气泡拦截能力两组无统计学差异。结论新型螺旋导流集成式膜式氧合器与进口膜式氧合器具有相似的有效性和安全性。

Objective To evaluate the safety and effectiveness of a new spiral flow integrated membrane oxygenator during car⁃diopulmonary bypass(CPB)procedure by using imported membrane oxygenator as the control product.Methods There were 4 re⁃search centers in this study.160 subjects were enrolled and 159 subjects(99.4%)completed the experiment(80 cases in the experi⁃mental group and 79 cases in the control group).Arterial blood samples were obtained before the start of CPB(T1),the lowest naso⁃pharyngeal temperature(31.5℃±1.5℃)after ascending aorta occlusion(T2),before the end of CPB(before ventilating)(T3),and within 24 hours after the end of CPB(T4).Blood gas analysis,blood routine test,free hemoglobin,etc.were measured to evaluate the effectiveness and safety indicators.The main effectiveness evaluation index was the compliance rate of the product.Safety evaluation in⁃cluded multiple indicators.Results①No significant difference had been found between the two groups in compliance rate(P=1.000);②No device defects occurred during the trial.No microembolism and hypoxemia occurred in all subjects during the trial;③There was no significant difference in bubble interception ability between the two groups.Conclusion The new spiral flow integrated membrane oxygenator has similar effectiveness and safety to the imported membrane oxygenator.