ASCEND (ARDS in Children and ECMO initiation strategies impact on Neuro-Development)

ASCEND（儿童 ARDS 和 ECMO 启动策略对神经发育的影响）

• 批准号: 10254392
• 负责人: Ryan Barbaro
• 金额: $ 65.09万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-05 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10254392
• 关键词: Acute; Address; Adult Respiratory Distress Syndrome; Age; Anticoagulation; Blood; Brain; Breathing; Cannulas; Child; Child Support; Childhood; Clinical; Clinical Trials; Communication; Consequentialism; Critically ill children; Data; Data Collection; Data Element; Equipoise; Evaluation; Extracorporeal Membrane Oxygenation; Failure; Family; Fatigue; Funding; Guidelines; Hemorrhage; High-Frequency Ventilation; Impairment; Intervention; Knowledge; Lead; Life; Longitudinal prospective study; Measures; Mechanical Ventilators; Mechanical ventilation; Morbidity - disease rate; Motor; National Heart, Lung, and Blood Institute; Nervous System Trauma; Nutritional Support; Organ failure; Outcome; Outcome Study; Oxygen; Patient-Focused Outcomes; Pediatric Acute Respiratory Distress Syndrome; Positioning Attribute; Prone Position; Protocols documentation; Pump lung; Quality of life; Randomized; Randomized Clinical Trials; Randomized Controlled Clinical Trials; Registries; Sensory; Site; Stroke; Supination; Support Groups; Techniques; Testing; Uncertainty; Ventilator; Ventilator-induced lung injury; artificial lung; blood pump; comparative effectiveness study; conventional therapy; experience; functional outcomes; functional status; health related quality of life; instrument; mental state; mortality; neurodevelopment; preservation; prospective; respiratory; response; systematic review; treatment as usual; ventilation

Project Abstract Decades after extracorporeal membrane oxygenation (ECMO) was first used to support children with severe pediatric acute respiratory distress syndrome (PARDS), pediatric intensivists lack both prospective studies of long-term outcomes in ECMO for PARDS and well-powered studies comparing the impact of ECMO initiation strategies on mortality and morbidity. While clinicians lack the equipoise necessary to randomize ECMO in dying children, there is uncertainty on if and when it is best to initiate ECMO to preserve survival, functioning, and quality of life. To answer the question, if and when ECMO should be initiated in children with severe PARDS, it is necessary to compare the long-term outcomes in ECMO supported children to otherwise similar children who did not receive ECMO at the same threshold if at all. An opportunity to address this question is provided by NHLBI-funded Prone and Oscillation Pediatric Clinical Trial (PROSpect) and the ECMO registry, Extracorporeal Life Support Organization (ELSO). PROSpect is a randomized clinical trial testing the impact of supine/prone positioning and conventional mechanical ventilation/high-frequency oscillatory ventilation on short and long-term clinical outcomes in 1,000 children with severe PARDS. PROSpect manages subjects with a rigorous protocol that reserves ECMO for protocol failure. The ELSO Registry includes children receiving usual care ECMO, initiated at the discretion of the intensivist. ASCEND (ARDS in Children and ECMO initiation strategies impact on Neuro-Development) will harmonize PROSpect and ELSO data collection and prospectively measure long-term functional status and quality of life in 550 children with severe PARDS from ELSO sites. ASCEND will then match children in both groups on their propensity to receive usual care ECMO. ASCEND combines real-world observational data (from ELSO) and a randomized clinical trial (from PROSpect) by matching similarly critically ill children treated under usual care ECMO or a rigorous ventilation protocol that reserves ECMO for protocol failure. Our specific aims include: Aim 1: We will test the hypotheses that one year after children receive usual care ECMO for PARDS, there will be a decline in long-term functional status and health-related quality of life as well as an increase in the proportion of children receiving respiratory support. Aim 2: We will test the hypotheses that 90-day mortality, one-year functional status, and one-year health- related quality of life are not equivalent for children with usual care ECMO (in ELSO) and PROSpect's protocolized therapies.

项目摘要 在体外膜肺氧合（ECMO）首次用于支持患有严重肺结核的儿童数十年后， 儿科急性呼吸窘迫综合征（PARDS），儿科重症监护医师缺乏前瞻性研究， ECMO治疗PARDS的长期结局和比较ECMO启动影响的把握度良好的研究 死亡率和发病率战略。虽然临床医生缺乏随机ECMO所需的平衡， 垂死的儿童，是否以及何时启动ECMO以维持生存，功能， 和生活质量。为了回答这个问题，如果和什么时候应该开始ECMO在儿童严重 PARDS，有必要将ECMO支持的儿童的长期结果与其他类似结果进行比较 没有接受ECMO的儿童，如果有的话。 一个机会来解决这个问题是由NHLBI资助的俯卧和振荡儿科临床 试验（前景）和ECMO登记处，体外循环生命支持组织（ELSO）。前景是一个 随机临床试验测试仰卧/俯卧位和传统机械 通气/高频振荡通气对1，000名患有 严重的PARDS。前景采用严格的方案管理受试者，该方案保留ECMO以应对方案失败。 ELSO登记研究包括接受常规ECMO护理的儿童，由重症监护医生酌情启动。 ASCEND（儿童ARDS和ECMO启动策略对神经发育的影响）将协调 前景和ELSO数据收集并前瞻性测量长期功能状态和生活质量 在ELSO中心的550名患有严重PARDS的儿童中。然后，ASCEND将在两个组中的孩子的 倾向于接受常规护理ECMO。ASCEND结合了真实世界的观测数据（来自ELSO）和 随机临床试验（来自前景），通过匹配在常规护理下接受治疗的类似危重患儿 ECMO或严格的通气方案，保留ECMO以应对方案失败。我们的具体目标包括： 目的1：我们将检验以下假设：在儿童接受常规ECMO治疗PARDS一年后， 长期功能状态和健康相关生活质量下降， 接受呼吸支持的儿童比例。 目标2：我们将检验90天死亡率、1年功能状态和1年健康状况的假设- 对于接受常规护理的ECMO（在ELSO中）和前景的儿童， 协议化治疗。