Division of Pediatric Intensive Care, Department of Pediatrics, Beatrix Children's Hospital, University Medical Center Groningen, Groningen, The Netherlands.
Pediatr Crit Care Med. 2012 Nov;13(6):632-8. doi: 10.1097/PCC.0b013e31824fbc37.
To explore what design would be reasonable, acceptable, and feasible for a pediatric trial investigating the effect of low tidal volume ventilation.
A two-round modified Delphi approach among pediatric intensivists with a visible special interest in mechanical ventilation.
None.
Pediatric intensivists.
None.
In the first questionnaire "experts" classified 64 items as "important," "not so important" or "not important" (June 2010). The second questionnaire included the 29 items having been classified by more than 50% of the experts as being "important" in the first questionnaire that needed to be ranked in order of importance (August 2010). Twenty-nine of 50 (64%) experts responded to the first questionnaire, and 28 of the 29 initial responders (96.6%) to the second questionnaire. Actual expert opinion favored the following: age of study population 0 yrs to 2 yrs, expected duration of ventilation ≥ 48 hrs, and stratification by the severity of hypoxemia (cutoff PaO(2)/FIO(2) < 200). The two study arms should compare the effect of 6 mL/kg vs. 10 mL/kg on mortality. However, these views of the experts face two major issues. First, 10 mL/kg does not represent standard of care. Second, numerous uncertainties render mortality unsuitable as primary measure of outcome including a large sample size (>1500).
Actual expert opinion favored investigating the effect of 6 mL/kg vs.10 mL/kg on mortality. Such a design suffers from various serious criticisms. Therefore, and in our opinion, a pediatric Acute Respiratory Distress Syndrome Network trial is not realistic.
探讨在一项针对低潮气量通气效果的儿科试验中，哪种设计是合理、可接受和可行的。
在对机械通气有明显特殊兴趣的儿科重症监护医生中进行两轮改良 Delphi 方法。
无。
儿科重症监护医生。
无。
在第一轮问卷中，“专家”将 64 项分类为“重要”、“不太重要”或“不重要”（2010 年 6 月）。第二轮问卷包括第一轮问卷中被超过 50%的专家归类为“重要”的 29 项需要按重要性排序的项目（2010 年 8 月）。在第一轮问卷中，50 名专家中的 29 名（64%）和 29 名初始回复者中的 28 名（96.6%）回复了第二轮问卷。实际专家意见倾向于以下内容：研究人群年龄为 0 岁至 2 岁，预计通气时间≥48 小时，以及根据低氧血症的严重程度分层（截定点 PaO2/FIO2<200）。两个研究组应比较 6mL/kg 与 10mL/kg 对死亡率的影响。然而，专家的这些观点面临两个主要问题。首先，10mL/kg 不代表标准治疗。其次，许多不确定性使得死亡率不适合作为主要的结果测量指标，包括大样本量（>1500）。
实际专家意见倾向于研究 6mL/kg 与 10mL/kg 对死亡率的影响。这种设计存在各种严重的批评。因此，我们认为，开展儿科急性呼吸窘迫综合征网络试验是不现实的。
