1 Department of Pediatrics and.
2 Child Health Evaluation and Research Center, University of Michigan, Ann Arbor, Michigan.
Am J Respir Crit Care Med. 2018 May 1;197(9):1177-1186. doi: 10.1164/rccm.201709-1893OC.
Extracorporeal membrane oxygenation (ECMO) has supported gas exchange in children with severe respiratory failure for more than 40 years, without ECMO efficacy studies.
To compare the mortality and functional status of children with severe acute respiratory failure supported with and without ECMO.
This cohort study compared ECMO-supported children to pair-matched non-ECMO-supported control subjects with severe acute respiratory distress syndrome (ARDS). Both individual case matching and propensity score matching were used. The study sample was selected from children enrolled in the cluster-randomized RESTORE (Randomized Evaluation of Sedation Titration for Respiratory Failure) clinical trial. Detailed demographic and daily physiologic data were used to match patients. The primary endpoint was in-hospital mortality. Secondary outcomes included hospital-free days, ventilator-free days, and change in functional status at hospital discharge.
Of 2,449 children in the RESTORE trial, 879 (35.9%) non-ECMO-supported patients with severe ARDS were eligible to match to 61 (2.5%) ECMO-supported children. When individual case matching was used (60 matched pairs), the in-hospital mortality rate at 90 days was 25% (15 of 60) for both the ECMO-supported and non-ECMO-supported children (P > 0.99). With propensity score matching (61 matched pairs), the ECMO-supported in-hospital mortality rate was 15 of 61 (25%), and the non-ECMO-supported hospital mortality rate was 18 of 61 (30%) (P = 0.70). There was no difference between ECMO-supported and non-ECMO-supported patients in any secondary outcomes.
In children with severe ARDS, our results do not demonstrate that ECMO-supported children have superior outcomes compared with non-ECMO-supported children. Definitive answers will require a rigorous multisite randomized controlled trial.
体外膜肺氧合(ECMO)已经在患有严重呼吸衰竭的儿童中支持气体交换 40 多年,但是没有 ECMO 疗效研究。
比较使用 ECMO 和不使用 ECMO 支持的严重急性呼吸衰竭儿童的死亡率和功能状态。
本队列研究将 ECMO 支持的儿童与严重急性呼吸窘迫综合征(ARDS)的配对非 ECMO 支持对照儿童进行比较。使用个体病例匹配和倾向评分匹配。研究样本选自参加集群随机 RESTORE(呼吸衰竭镇静滴定的随机评估)临床试验的儿童。使用详细的人口统计学和日常生理数据来匹配患者。主要终点是住院死亡率。次要结局包括住院期间无呼吸机天数、无呼吸机天数和出院时功能状态的变化。
在 RESTORE 试验的 2449 名儿童中,879 名(35.9%)非 ECMO 支持的严重 ARDS 患者有资格与 61 名(2.5%)ECMO 支持的儿童匹配。当使用个体病例匹配(60 对匹配)时,90 天的住院死亡率在 ECMO 支持和非 ECMO 支持的儿童中均为 25%(60 对中的 15 例)(P>0.99)。使用倾向评分匹配(61 对匹配)时,ECMO 支持的住院死亡率为 61 例中的 15 例(25%),非 ECMO 支持的住院死亡率为 61 例中的 18 例(30%)(P=0.70)。ECMO 支持和非 ECMO 支持的患者在任何次要结局上均无差异。
在患有严重 ARDS 的儿童中,我们的结果并未表明 ECMO 支持的儿童比非 ECMO 支持的儿童具有更好的结局。明确的答案需要一项严格的多中心随机对照试验。