PRONE POSITIONING IN PEDIATRIC ACUTE LUNG INJURY

描述：急性呼吸窘迫综合征(ARDS)导致显著 危重儿童的死亡率和发病率。尽管咄咄逼人 治疗。在2500名患有ARDS的儿童中，约有45%的人患有ARDS 一年将死亡，15%的幸存者将在 功能状态。俯卧位是一种很有前途的治疗辅助手段 改善气体交换，早期使用可能会改善临床病程 患者的急性肺损伤(ALI)/ARDS。这个项目的目的是 进行多中心、随机、非交叉、对照临床试验 早期、重复和延长俯卧位与仰卧位的比较 急性肺损伤或急性呼吸窘迫患儿的体位定位 综合症。研究对象包括180名接受呼吸机治疗的ALI/ARDS儿童。科目 会被随机分配到急性期的俯卧位或仰卧位 他们的ALI/ARDS疾病最多7天。学习治疗后(俯卧位 或仰卧位)所有仍在插管的患者将被定位 仰卧(通常的护理)，直到他们成功拔管或死亡。除 定位，两组受试者将以完全相同的方式进行管理 在这28天期间。主要终点是无呼吸机天数 28天的期限。次要终点，包括肺恢复时间 损伤、无器官衰竭天数、功能结果和死亡率。

DESCRIPTION: Acute Respiratory Distress Syndrome (ARDS) results in significant mortality and morbidity in critically ill children. Despite aggressive treatment. approximately 45% of the 2,500 children afflicted with ARDS each year will die and 15% of survivors will suffer significant impairment in functional status. Prone positioning is a promising therapeutic adjunct to improve gas exchange and, when used early, may improve the clinical course of the patient's acute lung injury (ALI)/ARDS. The purpose of this project is to conduct a multicenter, randomized, non-crossover, controlled clinical trial comparing early, repeated and prolonged prone positioning with supine positioning in children with acute lung injury or acute respiratory distress syndrome. Subjects will include 180 ventilated children with ALI/ARDS. Subjects will be randomly assigned to prone or supine positioning during the acute phase of their ALI/ARDS illness for a maximum of 7 days. After study treatment (prone or supine positioning) all patients who are still intubated will be positioned supine (usual care) until they are successfully extubated or die. Other than positioning, subjects in both groups will be managed in exactly the same way during, the 28-day period. The primary endpoint is ventilator free days during the 28-day period. Secondary end points, include time to recovery of lung injury, organ failure free days, functional outcome, and mortality.