Early Neuromuscular Blockade in the Acute Respiratory Distress Syndrome
Early Neuromuscular Blockade in the Acute Respiratory Distress Syndrome
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DOI：
10.1056/nejmoa1901686
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发表时间：
2019-05-23
影响因子：
158.5
通讯作者：
Angus, Derek C.
中科院分区：
文献类型：
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作者：
Moss, Marc;Huang, David T.;Angus, Derek C.
急性呼吸窘迫综合征（ARDS）患者接受机械通气时早期持续神经肌肉阻滞的益处尚不清楚。方法我们将中重度ARDS患者（定义为动脉氧分压与吸入氧分数的比值= 8 cm水柱）随机分为48小时持续输注顺利氨脲并伴随深度镇静（干预组）或常规护理方法，不使用常规神经肌肉阻滞，镇静目标较轻（对照组）。两组采用相同的机械通气策略，包括高PEEP策略。主要终点是90天时任何原因导致的院内死亡。结果试验在第二次中期分析时因无效而停止。我们招募了1006例中重度ARDS发病后早期（中位数，发病后7.6小时）的患者。在随机化后的前48小时内，干预组501例患者中的488例（97.4%）开始连续输注顺利库铵（中位输注时间为47.8小时;中位剂量为1807 mg），对照组505例患者中的86例（17.0%）接受神经肌肉阻滞剂（中位剂量为38 mg）。90天时，干预组有213名患者（42.5%）在出院前死亡，对照组有216名患者（42.8%）在出院前死亡（组间差异，-0.3个百分点; 95%置信区间，-6.4至5.9; P=0.93）。在医院期间，干预组患者比对照组患者体力活动较少，发生的不良心血管事件更多。在3个月、6个月和12个月时评估的终点没有一致的组间差异。结论：在采用高PEEP策略治疗的中重度ARDS患者中，早期持续输注顺铂的患者与采用镇静目标较轻的常规护理方法治疗的患者90天死亡率无显著差异。（由国家心脏，肺和血液研究所资助; ROSE ClinicalTrials.gov编号。这项试验回顾了大约10年前进行的研究，该研究表明早期神经肌肉阻滞对急性呼吸窘迫综合征患者的生存有益。这项新的试验没有显示神经肌肉阻滞在总生存率或其他临床结局方面的益处。
Background The benefits of early continuous neuromuscular blockade in patients with acute respiratory distress syndrome (ARDS) who are receiving mechanical ventilation remain unclear. Methods We randomly assigned patients with moderate-to-severe ARDS (defined by a ratio of the partial pressure of arterial oxygen to the fraction of inspired oxygen of = 8 cm of water) to a 48-hour continuous infusion of cisatracurium with concomitant deep sedation (intervention group) or to a usual-care approach without routine neuromuscular blockade and with lighter sedation targets (control group). The same mechanical-ventilation strategies were used in both groups, including a strategy involving a high PEEP. The primary end point was in-hospital death from any cause at 90 days. Results The trial was stopped at the second interim analysis for futility. We enrolled 1006 patients early after the onset of moderate-to-severe ARDS (median, 7.6 hours after onset). During the first 48 hours after randomization, 488 of the 501 patients (97.4%) in the intervention group started a continuous infusion of cisatracurium (median duration of infusion, 47.8 hours; median dose, 1807 mg), and 86 of the 505 patients (17.0%) in the control group received a neuromuscular blocking agent (median dose, 38 mg). At 90 days, 213 patients (42.5%) in the intervention group and 216 (42.8%) in the control group had died before hospital discharge (between-group difference, -0.3 percentage points; 95% confidence interval, -6.4 to 5.9; P=0.93). While in the hospital, patients in the intervention group were less physically active and had more adverse cardiovascular events than patients in the control group. There were no consistent between-group differences in end points assessed at 3, 6, and 12 months. Conclusions Among patients with moderate-to-severe ARDS who were treated with a strategy involving a high PEEP, there was no significant difference in mortality at 90 days between patients who received an early and continuous cisatracurium infusion and those who were treated with a usual-care approach with lighter sedation targets. (Funded by the National Heart, Lung, and Blood Institute; ROSE ClinicalTrials.gov number, .)This trial revisited research conducted about a decade ago that showed a survival benefit with early neuromuscular blockade in patients with acute respiratory distress syndrome. The new trial did not show a benefit with neuromuscular blockade with respect to overall survival or other clinical outcomes.