A Randomized Trial of Laryngeal Mask Airway in Neonatal Resuscitation
A Randomized Trial of Laryngeal Mask Airway in Neonatal Resuscitation
复制标题
喉罩气道用于新生儿复苏的一项随机试验
DOI：
10.1056/nejmoa2005333
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发表时间：
2020-11-26
影响因子：
158.5
通讯作者：
Tylleskar, Thorkild
中科院分区：
文献类型：
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作者：
Pejovic, Nicolas J.;Hook, Susanna Myrnerts;Tylleskar, Thorkild
背景面罩通气是出生窒息最常见的复苏方法。在低收入国家的新生儿复苏过程中，使用无套囊喉罩气道 (LMA) 通气比面罩通气具有潜在优势，但使用 LMA 是否能降低窒息新生儿的死亡率和发病率尚不清楚。 方法在乌干达进行的这项 3 期开放标签优效性试验中，我们随机分配需要正压通气的新生儿，由助产士使用 LMA 或面罩通气进行治疗。所有新生儿的估计孕龄至少为 34 周，估计出生体重至少为 2000 克，或两者兼而有之。主要结局是住院期间 7 天内死亡或因中重度缺氧缺血性脑病入住新生儿重症监护病房 (NICU) 的复合结局。结果 99.2% 的新生儿可获得完整的随访数据。 LMA 组 563 名新生儿中有 154 名 (27.4%) 发生主要结局事件，面罩组 591 名新生儿中有 144 名 (24.4%) 发生主要结局事件（调整相对风险，1.16；95% 置信区间 [CI]，0.90 至 1.51；P=0.26）。 LMA 组和面罩组分别有 21.7% 和 18.4% 的新生儿在 7 天内死亡（调整后相对风险为 1.21；95% CI，0.90 至 1.63），住院期间第 1 至 5 天因中重度缺氧缺血性脑病入住 NICU 的新生儿死亡率分别为 11.2% 和 18.4%。分别为 10.1%（调整后相对风险，1.27；95% CI，0.84 至 1.93）。在敏感性分析中，结果基本没有变化，其中缺失数据的新生儿被计为在 LMA 组中发生过主要结局事件，而在面罩组中则被视为未发生过此类事件。两组中预定义的干预相关不良事件的发生频率相似。 结论 对于窒息新生儿，助产士使用 LMA 是安全的，但在新生儿早期死亡和中重度缺氧缺血性脑病方面，LMA 并不优于面罩通气。 （由挪威研究委员会和妇幼健康干预科学中心资助；NeoSupra ClinicalTrials.gov 编号，NCT03133572。）在一项随机试验中，比较了无套囊喉罩通气和面罩对窒息新生儿的通气效果，在新生儿早期死亡和中度至重度缺氧缺血方面，喉罩气道并不优于面罩。脑病。
BackgroundFace-mask ventilation is the most common resuscitation method for birth asphyxia. Ventilation with a cuffless laryngeal mask airway (LMA) has potential advantages over face-mask ventilation during neonatal resuscitation in low-income countries, but whether the use of an LMA reduces mortality and morbidity among neonates with asphyxia is unknown.MethodsIn this phase 3, open-label, superiority trial in Uganda, we randomly assigned neonates who required positive-pressure ventilation to be treated by a midwife with an LMA or with face-mask ventilation. All the neonates had an estimated gestational age of at least 34 weeks, an estimated birth weight of at least 2000 g, or both. The primary outcome was a composite of death within 7 days or admission to the neonatal intensive care unit (NICU) with moderate-to-severe hypoxic-ischemic encephalopathy at day 1 to 5 during hospitalization.ResultsComplete follow-up data were available for 99.2% of the neonates. A primary outcome event occurred in 154 of 563 neonates (27.4%) in the LMA group and 144 of 591 (24.4%) in the face-mask group (adjusted relative risk, 1.16; 95% confidence interval [CI], 0.90 to 1.51; P=0.26). Death within 7 days occurred in 21.7% of the neonates in the LMA group and 18.4% of those in the face-mask group (adjusted relative risk, 1.21; 95% CI, 0.90 to 1.63), and admission to the NICU with moderate-to-severe hypoxic-ischemic encephalopathy at day 1 to 5 during hospitalization occurred in 11.2% and 10.1%, respectively (adjusted relative risk, 1.27; 95% CI, 0.84 to 1.93). Findings were materially unchanged in a sensitivity analysis in which neonates with missing data were counted as having had a primary outcome event in the LMA group and as not having had such an event in the face-mask group. The frequency of predefined intervention-related adverse events was similar in the two groups.ConclusionsIn neonates with asphyxia, the LMA was safe in the hands of midwives but was not superior to face-mask ventilation with respect to early neonatal death and moderate-to-severe hypoxic-ischemic encephalopathy. (Funded by the Research Council of Norway and the Center for Intervention Science in Maternal and Child Health; NeoSupra ClinicalTrials.gov number, NCT03133572.)In a randomized trial comparing ventilation with a cuffless laryngeal mask airway and with a face mask in neonates with asphyxia, the laryngeal mask airway was not superior to the face mask with respect to early neonatal death and moderate-to-severe hypoxic-ischemic encephalopathy.