Department of Pulmonary, Critical Care, and Sleep Medicine, Cook County Health, Chicago, IL, United States of America.
Department of Pulmonary, Critical Care, and Sleep Medicine, Cook County Health, Chicago, IL, United States of America.
J Crit Care. 2020 Jun;57:141-147. doi: 10.1016/j.jcrc.2020.02.018. Epub 2020 Feb 28.
To examine the definitions of acute respiratory failure, the characteristics of recruited patients, and the criteria for intubation used in randomized trials.
We searched MEDLINE for randomized trials of noninvasive respiratory support modalities in patients with de novo respiratory failure. We included trials from 1995 to 2017 that enrolled 40 or more patients and used intubation as an outcome.
We examined the reports of 53 trials that enrolled 7225 patients. There was wide variation in the use of variables for defining acute respiratory failure. Dyspnea was rarely measured and the increase in breathing effort was poorly defined. The characteristics of patients enrolled in trials changed over time and differed by the cause of respiratory failure. Intubation was poorly characterized. The criteria for intubation had more variables than the criteria for respiratory failure.
We identified deficiencies in the design and reporting of randomized trials, some of which can be remedied by investigators. We also found that patient characteristics differ by the type of respiratory failure. This knowledge can help clinician identify patients at the right moment to benefit from the tested interventions and investigators in developing criteria for enrollment in future trials.
检查急性呼吸衰竭的定义、募集患者的特征以及随机试验中插管的标准。
我们在 MEDLINE 上搜索了新发生呼吸衰竭的无创呼吸支持方式的随机试验。我们纳入了 1995 年至 2017 年期间纳入 40 例或以上患者且以插管为结局的试验。
我们检查了 53 项试验的报告，这些试验共纳入了 7225 例患者。用于定义急性呼吸衰竭的变量使用存在很大差异。呼吸困难很少被测量，呼吸努力的增加也没有得到很好的定义。试验中招募的患者的特征随时间而变化，并且因呼吸衰竭的原因而异。插管的特征描述很差。插管的标准比呼吸衰竭的标准有更多的变量。
我们发现随机试验的设计和报告存在缺陷，其中一些可以由研究者纠正。我们还发现，患者的特征因呼吸衰竭的类型而异。这一知识可以帮助临床医生在适当的时刻识别出受益于试验干预的患者，并帮助研究者制定未来试验的纳入标准。
