新生儿喉罩复苏效果的多中心随机对照临床研究

Multicenter randomized controlled clinical trial of the efficacy of laryngeal mask airway during neonatal resuscitation

目的 探讨喉罩通气用于新生儿复苏的可行性、有效性及安全性. 方法 选取2012年4月1日至2013年11月30日,在广东省6家三级甲等医院出生,生后需要正压通气复苏,胎龄≥34周或出生体重≥2 000 g的新生儿.以胎头娩出开始计时,初步复苏30 s后心率≥60次/min者根据出生日期奇偶性,随机分为喉罩1组（238例）与面罩组（274例）.若心率＜60次/min,随机分为喉罩2组（85例）与气管插管组（71例）.比较喉罩组与面罩组和气管插管组的复苏效果及不良反应.采用两独立样本t检验、秩和检验及x2检验进行统计学分析. 结果 （1）复苏效果：喉罩1组喉罩一次插入成功率为95.3％（227/238）,平均插入时间为（7.0±0.7）s.与面罩组相比,喉罩1组复苏成功率较高[96.6％（230/238）与79.6％（218/274）,x2=33.93,P=0.00],起效时间[（14.6±2.5）s与（18.3±5.3）s,t=-9.79,P=0.0 0]和通气时间较短[36.4 s（29.7～40.2 s）与50.2 s（40.3～63.3 s）,Z=12.23,P=0.00].与气管插管组相比,喉罩2组一次插入成功率、复苏成功率、起效时间差异均无统计学意义（P值均＞0.05）,但插入时间[（6.8±0.7）s与（8.0±0.9）s,t=-9.45,P=0.00]和通气时间较短[164.6 s（154.3～174.0 s）与173.4 s（162.3～185.2 s）,Z=3.16,P=0.00].喉罩1组与面罩组复苏前及生后1、2、3和5 min脉搏差异无统计学意义（P值均＞0.05）,但喉罩1组生后1、2、3和5 min经皮氧饱和度均高于面罩组[分别为（51.5±6.3）％与（48.3±7.9）％,t=2.45;（72.1±3.9）％与（70.1±4.7）％,t=2.62;（76.2±3.4）％与（74.3±5.1）％,t=3.04; （87.7±9.4）％与（84.5±3.4）％,t=5.31;P值均＜0.05].喉罩2组与气管插管组复苏前后脉搏及经皮氧饱和度差异均无统计学意义（P值均＞0.05）.喉罩1组与面罩组、喉罩2组与气管插管组复苏前后脐动脉血气、乳酸、血糖差值比较,差异亦均无统计学意义（P值均＞0.05）.（2）不良反应：喉罩1组与面罩组、喉罩2组与气管插管组不良反应发生率差异均无统计学意义[3.4％（8/238）与5.1％ （14/274）,x2=1.02,P=0.31; 3.5％ （3/85）与2.8％（2/71）,x2=0.00,P=1.0 0]. 结论 喉罩通气用于胎龄≥34周或出生体重≥2 000 g的新生儿复苏,操作简捷,且安全有效.

Objective To determine the feasibility,efficacy and safety of the laryngeal mask airway（LMA） ventilation in neonatal resuscitation.Methods Newborns weighing ≥ 2 000 g or delivered at ≥ 34 weeks gestation,who needed positive pressure ventilation,born between April 1,2012 and November 30,2013,in six tertiary hospitals of Guangdong Province,China,were enrolled.According to the parity of their birth date,neonates with a heart rate ≥ 60 beats per minute after initial resuscitation within 30 s,were randomly divided into laryngeal mask ventilation group 1 （LMA1 group,238 cases） and bag-mask ventilation group （BMV group,274 cases）.Neonates with a heart rate ＜60 beats per minute were randomly divided into laryngeal mask ventilation group 2 （LMA2 group,85 cases） and endotracheal intubation ventilation group （ETT group,71 cases）.The efficacy and adverse events among the groups were compared with t test,rank-sum test and x2 test.Results In the LMA 1 group,the successful insertion rate of the LMA at the first attempt was 95.3％ （227/238） and the insertion time was （7.0±0.7） s.Compared with the BMV group,the LMA1 group had a higher successful resuscitation rate [96.6％ （230/238） vs 79.6％ （218/274）,x2=33.96,P=0.00] and shorter response time [（14.6±2.5） s vs （18.3±5.3） s,t=-9.79,P=0.00] and ventilation time [36.4 s （29.7-40.2 s） vs 50.2 s （40.3-63.3 s）,Z=12.23,P=0.00].Compared with the ETT group,insertion time [（6.8±0.7） s vs （8.0±0.9） s,t=-9.45,P=0.00] and ventilation time [164.6 s （154.3-174.0 s） vs 173.4 s （162.3-185.2 s）,Z=3.16,P=0.00] were shorter in the LMA2 group （all P＜0.05）.There were no significant differences in heart rate before resuscitation and 1,2,3 and 5 min after fetal head delivery between the LMA1 and BMV groups （all P＞0.05）,but transcutaneous oxygen saturation （SpO2） at 1,2,3 and 5 min after fetal head delivery was higher in the LMA1 group [（51.5±6.3） ％ vs （48.3±7.9） ％,t=2.45; （72.1 ±3.9） ％ vs （70.1 ±4.7） ％,t=2.62; （76.2±3.4） ％ vs （74.3±5.1） ％,t=3.04; （87.7±9.4） ％ vs （84.5±3.4） ％,t=5.31; all P＜0.05].There were no significant differences between the LMA2 and ETT groups in heart rate and SpO2 before and after resuscitation （all P＞0.05）.Blood gas,lactic acid,and glucose levels before and after resuscitation showed no significant differences between the LMA1 and BMV groups,neither between the LMA2 and ETT groups （all P＞0.05）.There were no significant differences in the incidence of adverse events between the LMA1 and BMV groups [3.4％ （8/238） vs 5.1％ （14/274）,x2=1.02,P=0.31],and between the LMA2 and ETT groups [3.5％ （3/85） vs 2.8％ （2/71）,x2=0.00,P=1.00].Conclusions LMA ventilation is safe,effective and easy to implement for the resuscitation of neonates with a gestational age ≥ 34 weeks or birth weight ≥ 2 000 g.