Effect of prone positioning on clinical outcomes in children with acute lung injury - A randomized controlled trial
Effect of prone positioning on clinical outcomes in children with acute lung injury - A randomized controlled trial
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DOI：
10.1001/jama.294.2.229
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发表时间：
2005-07-13
影响因子：
120.7
通讯作者：
Arnold, JH
中科院分区：
文献类型：
--
作者：
Curley, MAQ;Hibberd, PL;Arnold, JH
背景 在非对照临床研究中，俯卧位似乎是安全的，并且可以改善患有急性肺损伤的儿科患者的氧合。然而，俯卧位对儿童临床结果的影响尚不清楚。 目的 检验以下假设：在 28 天结束时，采用俯卧位治疗的急性肺损伤婴儿和儿童比采用仰卧位治疗的婴儿和儿童有更多的无呼吸机天数。 设计、环境和患者 2001 年 8 月 28 日至 2004 年 4 月 23 日进行的多中心、随机、对照临床试验，共 102 项 儿科的。来自 7 个美国儿科重症监护室的年龄 2 周至 18 岁的患者接受仰卧位与俯卧位治疗。随机分组是隐藏的，分组也不是盲法。 干预 患者在满足急性肺损伤标准后 48 小时内被随机分为仰卧位或俯卧位，俯卧位组的患者在随机分组后 4 小时内进行卧位，并在疾病急性期每天保持俯卧位 20 小时，最多 7 天，之后再进行仰卧位。两组均使用肺保护性呼吸机和镇静方案、拔管准备测试以及血流动力学、营养和皮肤护理指南进行治疗。 主要结果测量无呼吸机天数至第 28 天。 结果 根据预先指定的无效停止规则，试验在计划的中期分析时停止。两组之间不使用呼吸机的天数没有差异（平均 [SD]，仰卧位 15.8 [8.5] 与俯卧位 15.6 [8.6]；平均差异，-0.2 天；95% Cl，-3.6 至 3.2；P=.91）。在控制了年龄、儿童死亡风险 III 评分、直接与间接急性肺损伤以及入组时的机械通气模式后，不使用呼吸机天数的调整后差异为 0.3 天（95% Cl，-3.0 至 3.5；P=.87）。次要终点没有差异，包括第 28 天存活且未使用呼吸机的比例 (P=.45)、全因死亡率 (P>.99)、肺损伤恢复时间 (P=.78)、无器官衰竭天数 (P=.88) 以及出院时或第 28 天的认知障碍 (P=.16) 或整体功能健康状况 (P=.12)。 体位并不能显着减少急性肺损伤儿科患者的无呼吸机天数或改善其他临床结果。
Context In uncontrolled clinical studies, prone positioning appeared to be safe and to improve oxygenation in pediatric patients with acute lung injury. However, the effect of prone positioning on clinical outcomes in children is not known.Objective To test the hypothesis that at the end of 28 days infants and children with acute lung injury treated with prone positioning would have more ventilator-free days than those treated with supine positioning.Design, Setting, and Patients Multicenter, randomized, controlled clinical trial conducted from August 28, 2001, to April 23, 2004, of 102 pediatric. patients from 7 US pediatric intensive care units aged 2 weeks to 18 years who were treated with supine vs prone positioning. Randomization was concealed and group assignment was not blinded.Intervention Patients were randomized to either supine or prone positioning within 48 hours of meeting acute lung injury criteria, with those patients in the prone group being positioned within 4 hours of randomization and remaining prone for 20 hours each day during the acute phase of their illness for a maximum of 7 days, after which they were positioned supine. Both groups were treated using lung protective ventilator and sedation protocols, extubation readiness testing, and hemodynamic, nutrition, and skin care guidelines.Main Outcome Measure Ventilator-free days to day 28.Results The trial was stopped at the planned interim analysis on the basis of the pre-specified futility stopping rule. There were no differences in the number of ventilator-free days between the 2 groups (mean [SD], 15.8 [8.5] supine vs 15.6 [8.6] prone; mean difference, -0.2 days; 95% Cl, -3.6 to 3.2; P=.91). After controlling for age, Pediatric Risk of Mortality III score, direct vs indirect acute lung injury, and mode of mechanical ventilation at enrollment, the adjusted difference in ventilator-free days was 0.3 days (95% Cl, -3.0 to 3.5; P=.87). There were no differences in the secondary end points, including proportion alive and ventilator-free on day 28 (P=.45), mortality from all causes (P>.99), the time to recovery of lung injury (P=.78), organ-failure-free days (P=.88), and cognitive impairment (P=.16) or overall functional health (P=.12) at hospital discharge or on day 28.Conclusion Prone positioning does not significantly reduce ventilator-free days or improve other clinical outcomes in pediatric patients with acute lung injury.