Impact of Cannulation Strategy on the Rate of Neurologic Injury in Infants With Respiratory Failure: A Propensity Score Analysis of the ELSO Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5,058
- 试验地点
- 1
- 主要终点
- Neurologic Injury
研究概览
简要总结
There has been increasing use of venoarterial (VA) extracorporeal membrane oxygenation (ECMO) for infants with respiratory failure, up to 92% of neonatal respiratory support in 2021. This study seeks to leverage the increased use of VA ECMO in this cohort to enrich an evaluation of the differences in rate of intracranial hemorrhage and ischemic stroke between venovenous (VV) and VA ECMO among infants with respiratory failure where clinicians may choose either strategy.
This project is a retrospective review of data in the ELSO registry.
详细描述
From 2019-2021, there was increased use of venoarterial (VA) extracorporeal membrane oxygenation (ECMO) for infants with respiratory failure, up to 92% of neonatal respiratory support in 2021. The primary aim is to estimate the average effect on the rate of neurologic injury of VA ECMO versus venovenous (VV) among infants with respiratory failure over the period 2013-2018, during which clinicians could choose either cannulation strategy. This causal effect will be estimated using an inverse propensity weighted (IPW) approach. Secondarily, the investigators will project this estimated treatment effect forward into the period 2019-2021. The beginning of this period roughly corresponds to start of increased use of VA ECMO. Under the assumption of a homogenous treatment effect across both study periods, the rate of neurologic injury that would have occurred in 2019-2021 will be estimated, had the rate of VA ECMO not increased relative to pre-2019 levels. The hypothesis is that the results will point to an increased rate of neurologic injury starting in 2019 due to the increased use of VA ECMO.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 0 Days 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient weighed less than or equal to 10kg at start of ECMO
- •Pulmonary support was the indication for ECLS
- •Initial cannulation strategy was VV or VA
- •The run occurred during the period 2013-2023
排除标准
- •Patient had CDH
- •Patient was post-cardiotomy
- •Non-conventional initial cannulation strategies were employed, such as
- •Central Cannulation (surrogate for inability to achieve peripheral cannulation)
- •Veno-veno-arterial ECMO
- •Initial cannulation approach reported as "other"
- •Patient was transported into or out of ELSO center on ECMO support
- •Patient had pre-ECLS Cardiac Arrest
- •Patient did not have subsequent ECMO runs in the ELSO registry
结局指标
主要结局
Neurologic Injury
时间窗: during critical illness supported by ECLS up to 14 days after ECLS stop time
The outcome will be the composite occurrence of neurologic injury (ischemic stroke, intracranial hemorrhage, and brain death) that arises during critical illness supported by extracorporeal life support (ECLS) as reported to the Extracorporeal Life Support Organization (ELSO) registry, coded as a 0/1 variable (0 = no occurrence was reported during or after ECMO; 1 = one or more occurrence was reported).
次要结局
- Mortality(through study completion (ECLS hospital discharge), an average of 2 months)
- Individual neurologic injury(during the procedure (ECLS support), and up to 14 days days after ECLS stop time)
- Discharge Disposition(through study completion (ECLS hospital discharge), an average of 2 months)
- Duration of ECMO support(during the procedure (ECLS support))
研究者
Joseph Kohne (Pediatrics)
Clinical Assistant Professor
University of Michigan