关于在有或没有压力支的儿童中进行自发呼吸试验的非劣势随机对照试验的协议
José Colleti Junior1, Orlei Ribeiro de Araujo2, Karina Tavares Weber1
1Department of Pediatrics, Hospital das Clínicas, Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo - Ribeirão Preto (SP), Brazil.
Critical care science
|December 19, 2025
概括
本研究将持续正气道压力 (CPAP) 与需要机械通风的儿童在自发呼吸试验期间的压力支持进行比较. 目标是确定CPAP是否与压力支无差,以获得成功的输出管.
科学领域:
- 儿科重症监护医药 儿科重症监护医药
- 呼吸系统生理学 呼吸系统生理学
- 临床试验方法论 临床试验方法论
背景情况:
- 机械通风断奶对于儿科重症监护室 (PICU) 患者至关重要.
- 最佳自发呼吸试验 (SBT) 方法缺乏可靠的证据.
- 这项研究解决了对儿童基于证据的SBT方法的需求.
研究的目的:
- 为了比较机械通风儿童在SBT期间持续正气道压力 (CPAP) 与压力支 (PS) 的非劣势.
- 评价成功从机械通风中获得释放作为主要结果.
- 评估二次结果,包括输出管后呼吸支和PICU停留时间.
主要方法:
- 多中心,开放标签,非劣势随机对照试验 (NCT06593288).
- 包括:儿童年龄<18岁,>36周修正妊娠年龄,需要侵入性机械通风≥24小时,并准备奶.
- 在SBT期间随机分配到CPAP或PS;主要结果:成功释放≥48小时后的输出管.
主要成果:
- 研究结果预计将在研究完成后的一年内公布.
- 主要结果是成功的输出管和从机械通风中解放出来.
- 二级结局侧重于呼吸支需求和PICU停留时间.
结论:
- 在重症儿童中指导SBT的证据有限.
- 这项试验严格比较CPAP和SBT期间的压力支.
- 这些发现将为儿科机械通风提供最佳的断奶策略.
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