Extracorporeal Membrane Oxygenation for Severe Acute Respiratory Distress Syndrome

Extracorporeal Membrane Oxygenation for Severe Acute Respiratory Distress Syndrome
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DOI:
10.1056/nejmoa1800385
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发表时间:
2018-05-24
影响因子:
158.5
通讯作者:
Mercat, A.
Mercat, A.
中科院分区:
医学1区
文献类型:
--
作者:
Combes, A.;Hajage, D.;Mercat, A.

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静脉-静脉体外膜肺氧合(ECMO)在严重急性呼吸窘迫综合征(ARDS)患者中的疗效仍存在争议。如三个标准之一所示-动脉氧分压(Pao(2))与吸入氧分数(Fio(2))的比率低于50 mm Hg持续3小时以上; Pao(2):Fio(2)低于80 mm Hg持续6小时以上;或动脉血pH低于7.25,动脉二氧化碳分压至少60 mm Hg持续6小时以上-接受立即静脉-静脉ECMO(ECMO组)或继续常规治疗(对照组)。对于对照组中患有难治性低氧血症的患者,可以交叉至ECMO。主要终点是60天的死亡率。在60天,ECMO组124例患者中有44例(35%)死亡,对照组125例患者中有57例(46%)死亡(相对危险度,0.76; 95%可信区间[CI],0.55 - 1.04; P = 0.09)。对照组35例患者(28%)在随机化后平均(+/- SD)6.5 +/- 9.7天交叉至ECMO,其中20例患者(57%)死亡。除了ECMO组导致输血的出血事件比对照组多之外,两组之间的并发症频率没有显著差异(46% vs. 28%的患者;绝对风险差异,18个百分点; 95% CI,6 - 30)以及更多的重度血小板减少症病例(27% vs. 16%;绝对风险差异,11个百分点; 95% CI,0 - 21)和缺血性卒中病例较少(无患者vs. 5%;绝对风险差异,-5个百分点;结论:在极重度ARDS患者中,ECMO治疗的60天死亡率并不显著低于包括ECMO作为抢救治疗的常规机械通气策略。
BACKGROUNDThe efficacy of venovenous extracorporeal membrane oxygenation (ECMO) in patients with severe acute respiratory distress syndrome (ARDS) remains controversial.METHODSIn an international clinical trial, we randomly assigned patients with very severe ARDS, as indicated by one of three criteria - a ratio of partial pressure of arterial oxygen (Pao(2)) to the fraction of inspired oxygen (Fio(2)) of less than 50 mm Hg for more than 3 hours; a Pao(2):Fio(2) of less than 80 mm Hg for more than 6 hours; or an arterial blood pH of less than 7.25 with a partial pressure of arterial carbon dioxide of at least 60 mm Hg for more than 6 hours - to receive immediate venovenous ECMO (ECMO group) or continued conventional treatment (control group). Crossover to ECMO was possible for patients in the control group who had refractory hypoxemia. The primary end point was mortality at 60 days.RESULTSAt 60 days, 44 of 124 patients (35%) in the ECMO group and 57 of 125 (46%) in the control group had died (relative risk, 0.76; 95% confidence interval [CI], 0.55 to 1.04; P = 0.09). Crossover to ECMO occurred a mean (+/- SD) of 6.5 +/- 9.7 days after randomization in 35 patients (28%) in the control group, with 20 of these patients (57%) dying. The frequency of complications did not differ significantly between groups, except that there were more bleeding events leading to transfusion in the ECMO group than in the control group (in 46% vs. 28% of patients; absolute risk difference, 18 percentage points; 95% CI, 6 to 30) as well as more cases of severe thrombocytopenia (in 27% vs. 16%; absolute risk difference, 11 percentage points; 95% CI, 0 to 21) and fewer cases of ischemic stroke (in no patients vs. 5%; absolute risk difference, -5 percentage points; 95% CI, -10 to -2).CONCLUSIONSAmong patients with very severe ARDS, 60-day mortality was not significantly lower with ECMO than with a strategy of conventional mechanical ventilation that included ECMO as rescue therapy.