Curley Martha A Q, Hibberd Patricia L, Fineman Lori D, Wypij David, Shih Mei-Chiung, Thompson John E, Grant Mary Jo C, Barr Frederick E, Cvijanovich Natalie Z, Sorce Lauren, Luckett Peter M, Matthay Michael A, Arnold John H
Children's Hospital Boston, Medical-Surgical Intensive Care Unit, 300 Longwood Ave, Boston, MA 02115, USA.
JAMA. 2005 Jul 13;294(2):229-37. doi: 10.1001/jama.294.2.229.
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.
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.
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.
Ventilator-free days to day 28.
The trial was stopped at the planned interim analysis on the basis of the prespecified 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% CI, -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% CI, -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.
Prone positioning does not significantly reduce ventilator-free days or improve other clinical outcomes in pediatric patients with acute lung injury.
在非对照临床研究中，俯卧位似乎对患有急性肺损伤的儿科患者是安全的，并且能改善氧合。然而，俯卧位对儿童临床结局的影响尚不清楚。
检验这一假设，即在28天结束时，接受俯卧位治疗的急性肺损伤婴幼儿和儿童比接受仰卧位治疗的患者有更多无呼吸机天数。
设计、地点和患者：2001年8月28日至2004年4月23日在美国7个儿科重症监护病房进行的一项多中心、随机、对照临床试验，纳入102例年龄在2周至18岁的儿科患者，分别接受仰卧位或俯卧位治疗。随机分组方案保密，分组未设盲。
患者在符合急性肺损伤标准后48小时内随机分为仰卧位或俯卧位，俯卧组患者在随机分组后4小时内采取俯卧位，在疾病急性期每天俯卧20小时，最长7天，之后改为仰卧位。两组均采用肺保护性通气和镇静方案、拔管准备测试以及血流动力学、营养和皮肤护理指南。
至第28天的无呼吸机天数。
根据预先设定的无效性停止规则，在计划的中期分析时试验停止。两组的无呼吸机天数无差异（平均值[标准差]，仰卧位组为15.8[8.5]天，俯卧位组为15.6[8.6]天；平均差异为-0.2天；95%置信区间为-3.6至3.2；P = 0.91）。在控制年龄、儿科死亡风险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，调整后的无呼吸机天数差异为0.3天（95%置信区间为-3.0至3.5；P = 0.87）。次要终点无差异，包括第28天存活且无呼吸机的比例（P = 0.45）、各种原因导致的死亡率（P>0.99）、肺损伤恢复时间（P = 0.78）、无器官衰竭天数（P = 0.88）以及出院时或第28天的认知障碍（P = 0.16）或总体功能健康状况（P = 0.12）。
俯卧位并不能显著减少患有急性肺损伤的儿科患者的无呼吸机天数或改善其他临床结局。
