一个bstract
临床试验中使用的标准鉴定呼吸衰竭患者以及何时插管患者可能不适用于临床实践https://bit.ly/3qamcyt
致编辑:
t奥宾等。[[1] pointed in their editorial to the limitations of randomised trials in determining the effect of noninvasive modalities on the intubation of patients with respiratory failure. My colleagues and I have recently examined many design aspects of 53 randomised trials that evaluated the effect of noninvasive ventilation and high flow oxygen therapy on the outcomes of patients with acute respiratory failure [2]。我们的发现支持社论中突出显示的许多要点。
First, trial circumstances vary significantly. Patients were enrolled into the reviewed trials if they met a definition of respiratory failure that, on average, included four criteria. The most commonly used criterion was respiratory rate, with 79% of the trials requiring a patient to have a rate above a certain threshold. However, the range of the threshold was wide (from 20 breaths per min to 36 breaths per min). The range for the arterial-to-inspired oxygen (pAO2/Fio2) ratio, which was a criterion in 50% of trials, was also wide (from 170 to 400). Although the averages of these two variables indicated that patients were generally tachypnoeic (mean rate 31 breaths per min) and hypoxaemic (ratio 174), the coefficients of variation for these variables were large (23% and 38%, respectively) [2]。It seems difficult to believe that experienced clinicians would consider all of these patients as candidates for respiratory support beyond a simple facemask.
second, breathing effort, the most common reason for intubation [3],在临床试验中被忽略。我们发现,呼吸努力和呼吸困难少于呼吸衰竭(分别为39%和28%),而不是呼吸率和比率。他们也很少报道(分别为0%和7%)。使用呼吸努力作为插管标准也是如此。我们还发现,用于描述呼吸努力的语言含糊不清且极其可变[2]。
第三,临床医生不把管子插进基于criteria, but clinical trials frequently have them. In our review, we found that intubation decision was based on eight criteria. These criteria were combined in various ways: 53% of trials required fulfilling any of the criteria, 30% required fulfilling more than one, and 17% did not indicate how to use the criteria. Two thirds of the trials did not provide a clinical justification or a reference for the intubation criteria [2]。我们还确定,没有一个试验报告如何监测患者何时符合插管标准。患者是否以固定的间隔进行检查以确定何时符合足够的插管标准?还是临床医生和研究人员是由他们的格式塔触发的,患者的病情恶化,然后决定确定是否满足插管标准?
第四,做出插管决策的个人各不相同。尽管研究人员和临床医生肯定会关注患者的结果,但研究人员也有兴趣确认其假设,而临床医生则希望避免不必要的干预措施。我们发现,在45%的试验中,患者的主要团队做出了插管决定,而47%的试验未指定谁做出决定[2]。
to highlight the disagreement between intubation criteria and the clinical decision for intubation, we identified seven trials that reported the percentage of patients that met the intubation criteria and the percentage of patients that were intubated. On average, 40% of the patients that met intubation criteria were intubated [2]。换句话说,如果插管决策仅基于标准,那么插管的60%将是不必要的,不道德的和有害的。
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Footnotes
Conflict of interest: A. Tulaimat has nothing to disclose.
- receivedJanuary 7, 2021.
- 公认2021年1月12日。
- Copyright ©The authors 2021.
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