Extracorporeal membrane oxygenation (ECMO) is a high-risk and low-volume life support with increasing clinical study. However, heterogenous outcome definitions impede data assimilation into evidence to guide practice. The Academic Research Consortium (ARC), an international collaborative forum committed to facilitating the creation of stakeholder-driven consensus nomenclature and outcomes for clinical trials of medical devices, supported the ECMO Core Elements Needed for Trials Regulation And quality of Life (ECMO-CENTRAL) ARC. The ECMO-CENTRAL ARC was assembled to develop definitions of paediatric ECMO adverse events for use in clinical trials and regulatory device evaluation. An initial candidate list of ECMO adverse events derived from the mechanical circulatory support ARC was supplemented with a review of ECMO-relevant adverse event definitions collated from literature published between Jan 1, 1988, and Feb 20, 2023. Distinct teams of international topic experts drafted separate adverse event definitions that were harmonised to existing literature when appropriate. Draft definitions were revised for paediatric ECMO relevance with input from patients, families, and an international expert panel of trialists, clinicians, statisticians, biomedical engineers, device developers, and regulatory agencies. ECMO-CENTRAL ARC was revised and disseminated across research societies and professional organisations. Up to three rounds of internet-based anonymous surveys were planned as a modified Delphi process. The expert panel defined 13 adverse event definitions: neurological, bleeding, device malfunction, acute kidney injury, haemolysis, infection, vascular access-associated injury, non-CNS thrombosis, hepatic dysfunction, right heart failure, left ventricular overload, lactic acidaemia, and hypoxaemia. Definitional structure varied. Among 165 expert panel members, 114 were eligible to vote and 111 voted. Consensus was achieved for all proposed definitions. Agreement ranged from 82% to 95%. ECMO-CENTRAL ARC paired rigorous development with methodical stakeholder involvement and dissemination to define paediatric ECMO adverse events. These definitions will facilitate new research and the assimilation of data across clinical trials and ECMO device evaluation in children.

中文翻译：

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儿童体外膜氧合相关不良事件的定义：ECMO-CENTRAL ARC 国际德尔菲流程的结果。


体外膜肺氧合（ECMO）是一种高风险、低容量的生命支持，临床研究日益增多。然而，不同的结果定义阻碍了将数据同化为指导实践的证据。学术研究联盟 (ARC) 是一个国际合作论坛，致力于促进为医疗器械临床试验创建利益相关者驱动的共识命名法和结果，支持试验监管和生活质量所需的 ECMO 核心要素 (ECMO-CENTRAL)弧。 ECMO-CENTRAL ARC 的组建是为了制定儿科 ECMO 不良事件的定义，用于临床试验和监管设备评估。源自机械循环支持 ARC 的 ECMO 不良事件初步候选清单，补充了对 1988 年 1 月 1 日至 2023 年 2 月 20 日出版的文献中整理的 ECMO 相关不良事件定义的审查。由不同的国际主题专家团队起草单独的不良事件定义，并在适当时与现有文献进行协调。根据患者、家属以及由试验人员、临床医生、统计学家、生物医学工程师、设备开发商和监管机构组成的国际专家小组的意见，针对儿科 ECMO 相关性对定义草案进行了修订。 ECMO-CENTRAL ARC 进行了修订并在研究协会和专业组织中传播。作为修改后的德尔菲流程，计划进行多达三轮基于互联网的匿名调查。 专家小组定义了 13 种不良事件定义：神经系统、出血、装置故障、急性肾损伤、溶血、感染、血管通路相关损伤、非中枢神经系统血栓形成、肝功能障碍、右心衰竭、左心室超负荷、乳酸血症和低氧血症。定义结构各不相同。 165 名专家小组成员中，114 名有资格投票，111 名参加了投票。所有提议的定义都达成了共识。同意率从 82% 到 95% 不等。 ECMO-CENTRAL ARC 将严格的开发与有条理的利益相关者参与和传播相结合，以定义儿科 ECMO 不良事件。这些定义将促进新的研究以及儿童临床试验和 ECMO 设备评估数据的同化。