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无重症监护病房(ICU)天数作为危重症儿科患者临床试验中更敏感的主要结局指标。

ICU-free days as a more sensitive primary outcome for clinical trials in critically ill pediatric patients.

作者信息

Cho Hanjin, Wendelberger Barbara, Gausche-Hill Marianne, Wang Henry E, Hansen Matthew, Bosson Nichole, Lewis Roger J

机构信息

Department of Emergency Medicine College of Medicine Korea University Seoul Korea.

Berry Consultants, LLC Austin Texas USA.

出版信息

J Am Coll Emerg Physicians Open. 2021 Jul 7;2(4):e12479. doi: 10.1002/emp2.12479. eCollection 2021 Aug.

DOI:10.1002/emp2.12479
PMID:34263247
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8262607/
Abstract

BACKGROUND

Our objective was to assess the association between intensive care unit (ICU)-free days and patient outcomes in pediatric prehospital care and to evaluate whether ICU-free days is a more sensitive outcome measure for emergency medical services research in this population.

METHODS

This study used data from a previous pediatric prehospital trial. The original study enrolled patients ≤12 years of age and compared bag-valve-mask-ventilation (BVM) versus endotracheal intubation (ETI) during prehospital resuscitation. For the current study, we defined ICU-free days as 30 minus the number of days in the ICU (range, 0-30 days) and assigned 0 ICU-free days for death within 30 days. We compared ICU-free days between the original study treatment groups (BVM vs ETI) and with the original trial outcomes of survival to hospital discharge and Pediatric Cerebral Performance Category (PCPC).

RESULTS

Median ICU-free days for the BVM group (n = 404) versus ETI group (n = 416) was not statistically different: 0 ICU-free days (interquartile range, 0-10) versus 0 (0-0), = 0.219. Median ICU-free days were greater for BVM group in 3 subgroups: foreign body aspiration 30 (0-30) versus 0 (0-21),  = 0.028; child maltreatment 0 (0-14.2) versus 0 (0-0), = 0.004; and respiratory arrest 25 (1-29) versus 7.5 (0-27.7), = 0.015. In the original trial, neither survival nor PCPC demonstrated differences in all 3 subgroups-survival was greater with BVM for child maltreatment and respiratory arrest and favorable PCPC was greater with BVM for foreign body aspiration. Overall, in the current study, patients with more ICU-free days also had greater survival to hospital discharge and more favorable PCPC scores.

CONCLUSIONS

This initial study of the association between ICU-free days and patient outcomes during prehospital pediatric resuscitation appears to support the use of ICU-free days as a clinical endpoint in this population. ICU-free days may be more sensitive than either mortality or PCPC alone while capturing aspects of both measures.

摘要

背景

我们的目标是评估儿科院前急救中无重症监护病房(ICU)天数与患者预后之间的关联,并评估无ICU天数是否是该人群急诊医疗服务研究中更敏感的预后指标。

方法

本研究使用了之前一项儿科院前试验的数据。原研究纳入了年龄≤12岁的患者,并比较了院前复苏期间气囊面罩通气(BVM)与气管插管(ETI)的效果。对于本研究,我们将无ICU天数定义为30减去在ICU的天数(范围为0至30天),并将30天内死亡的患者无ICU天数指定为0天。我们比较了原研究治疗组(BVM与ETI)之间的无ICU天数,以及与原试验中出院存活和小儿脑功能分类(PCPC)的结果。

结果

BVM组(n = 404)与ETI组(n = 416)的无ICU天数中位数无统计学差异:分别为0天(四分位间距,0至10)和0天(0至0),P = 0.219。在3个亚组中,BVM组的无ICU天数中位数更高:异物吸入亚组为30天(0至30)对0天(0至21),P = 0.028;虐待儿童亚组为0天(0至14.2)对0天(0至0),P = 0.004;呼吸骤停亚组为25天(1至29)对7.5天(0至27.7),P = 0.015。在原试验中,在所有3个亚组中,存活情况和PCPC均无差异——对于虐待儿童和呼吸骤停,BVM组的存活率更高;对于异物吸入,BVM组的良好PCPC评分更高。总体而言,在本研究中,无ICU天数更多的患者出院存活率也更高,PCPC评分更优。

结论

这项关于儿科院前复苏期间无ICU天数与患者预后之间关联的初步研究似乎支持将无ICU天数用作该人群的临床终点。无ICU天数可能比单独的死亡率或PCPC更敏感,同时涵盖了这两种指标的各个方面。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4ada/8262607/65b88533f8d8/EMP2-2-e12479-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4ada/8262607/2814a5c1c9ab/EMP2-2-e12479-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4ada/8262607/65b88533f8d8/EMP2-2-e12479-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4ada/8262607/2814a5c1c9ab/EMP2-2-e12479-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4ada/8262607/65b88533f8d8/EMP2-2-e12479-g002.jpg

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