The feasibility of conducting clinical trials in infants and children with acute respiratory failure
The feasibility of conducting clinical trials in infants and children with acute respiratory failure
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DOI：
10.1164/rccm.200210-1175oc
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发表时间：
2003-05-15
影响因子：
24.7
通讯作者：
Cheifetz, IM
中科院分区：
文献类型：
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作者：
Randolph, AG;Meert, KL;Cheifetz, IM
在危重、机械通气的儿童中设计强有力的临床试验需要了解儿科呼吸衰竭的流行病学和病程。作为临床试验的一部分，我们连续6个月对北美9个大型儿科重症监护病房(ICU)中所有机械通气的儿童进行了筛查。在6,403名ICU住院患者中，1,096名(17.1%)需要至少24小时的机械呼吸机支持。在这些人中，701人(%)符合一个或多个试验招生排除标准。排出的常见原因是上呼吸道阻塞(13.5%)和青紫型先天性心脏病(11.5%)。9.7%的患者生命支持干预受到限制，5.5%的患者长期依赖呼吸机。在符合呼吸衰竭研究条件的患者中，62.4%的患者被诊断为急性肺部疾病，14.2%的患者患有神经系统疾病，8.9%的患者患有心脏病。43.2%的患者存在慢性基础疾病。最常见的急性诊断是婴儿毛细支气管炎(43.6%)和1岁及以上儿童肺炎(24.5%)。死亡率很低(1.6%)，中位呼吸机持续时间为7天。危重儿童的临床试验设计是可行的，但必须考虑到不同的人群、不常见的死亡率和较短的机械通气时间。
Designing robust clinical trials in critically ill, mechanically ventilated children requires an understanding of the epidemiology and course of pediatric respiratory failure. As part of a clinical trial, we screened all mechanically ventilated children in nine large pediatric intensive care units (ICUs) across North America for 6 consecutive months. Of 6,403 total ICU admissions, 1,096 (17.1%) required mechanical ventilator support for a minimum of 24 hours. Of these, 701 (64%) met one or more exclusion criteria for trial enrollment. Common reasons for exclusion were upper airway obstruction (13.5%) and cyanotic congenital heart disease (11.5%). Life support interventions were restricted for 9.7% of patients, and 5.5% were chronically ventilator dependent. In the patients who were eligible for respiratory failure studies, 62.4% had an acute primary diagnosis of pulmonary disease, 14.2% neurologic disease, and 8.9% cardiac disease. Chronic underlying conditions were present in 43.2% of the patients. The most common acute diagnosis was bronchiolitis in infants (43.6%) and pneumonia in children 1 year old and older (24.5%). Mortality was rare (1.6%), and the median duration of ventilation was 7 days. The design of clinical trials in critically ill children is feasible but must account for the diverse population, infrequent mortality, and short duration of mechanical ventilation.