PRONE POSITIONING IN PEDIATRIC ACUTE LUNG INJURY

描述：急性呼吸窘迫综合征（ARDS）导致显著的 重症儿童的死亡率和发病率。尽管进行了积极 治疗在2,500名患有ARDS的儿童中， 一年后死亡，15%的幸存者将遭受重大损害， 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，并且在早期使用时，可以改善 急性肺损伤（ALI）/ARDS。该项目的目的是 开展多中心、随机、非交叉、对照临床试验 比较早期、重复和长期俯卧位与仰卧位 急性肺损伤或急性呼吸窘迫患儿的体位 综合征受试者将包括180名接受机械通气的ALI/ARDS儿童。科目 将在急性期随机分配至俯卧位或仰卧位 他们的ALI/ARDS疾病最多持续7天。研究治疗后（倾向于 或仰卧位）将所有仍在插管的患者 直到他们成功拔管或死亡。除了 定位，两组受试者的管理方式完全相同 在这28天的时间里。主要终点是治疗期间的无呼吸机天数。 28天的时间。次要终点，包括肺恢复时间 损伤、无器官衰竭天数、功能结局和死亡率。

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.