经鼻间歇正压通气治疗新生儿呼吸衰竭的随机对照研究

Nasal intermittent positive pressure ventilation versus nasal continuous positive airway pressure for the treatment of neonatal respiratory failure:a prospective,randomized,controlled study

目的比较经鼻间歇正压通气(nIPPV)与经鼻持续气道正压通气(nCPAP)在新生儿呼吸衰竭中的疗效。方法采用RCT研究的方法,选择2008年1～12月在第三军医大学大坪医院NICU住院的呼吸衰竭新生儿作为研究对象,按随机数字表法将研究对象随机分为nIPPV组和nCPAP组,分别实施nIPPV或nCPAP干预,观察患儿动脉血气分析、应用nIPPV和nCPAP时间、并发症和预后等指标,比较nIPPV组和nCPAP组治疗后需气管插管行机械通气的比例及其预后结局。结果研究期间nIPPV组纳入48例,nCPAP组纳入53例。两组在性别构成比、胎龄、年龄、出生体重、出生后5 m inApgar评分、新生儿急性生理学评分和应用肺表面活性物质比例等方面差异无统计学意义(P均>0.05)。两组呼吸衰竭原发病分布差异无统计学意义(P>0.05)。两组治疗前血气分析指标差异均无统计学意义(P均>0.05),nIPPV组治疗后1 h血气分析pH和PaO2显著高于nCPAP组(P<0.05)。nIPPV组治疗成功率为77.1%(37/48例),nCPAP组为62.3%(33/53例),nIPPV组显著高于nCPAP组(P<0.05)。nIPPV组和nCPAP组治疗成功的患儿平均应用nIPPV和nCPAP的时间差异无统计学意义(P均>0.05)。nIPPV组的预后结局中治愈和好转出院45/48例(93.8%),nCPAP组为46/53例(86.8%),两组差异无统计学意义(P>0.05)。结论与nCPAP相比,nIPPV治疗可显著降低呼吸衰竭新生儿气管插管行机械通气的比例。

Objective Mechanical ventilation is associated with neonatal ventilator-associated pulmonary injury and bronchopulmonary dysplasia. Nasal continuous positive airway pressure （nCPAP） has been shown some effects on non-invasive respiratory support, but a lot of patients treated with nCPAP still need to be incubated and ventilated. The purpose of this study was to evaluate whether nasal intermittent positive pressure ventilation （nIPPV） would decrease the requirement for endotracheal ventilation compared with nCPAP in the treatment of respiratory failure in preterm and term infants. Methods A prospective, randomized, controlled and single-center study was registered in Clinical Trial, USA （Protocol ID： NCR2008053, ClinicalTrials. gov ID： NCT0078062 ）. Neonatal infants were randomly divided into nIPPV group and nCPAP group from January 2008 to December 2008 in a neonatal intensive care unit （NICU） of Daping Hospital, Third Military Medical University. The blood gas analysis, time of using nCPAP and nIPPV, ratio of requirement for endotracheal ventilation and the prognosis were investigated. Results Totally 1 369 neonatal infants were hospitalized in the NICU within the period of the study. 124 infants suffered from neonatal respiratory failure. Of them, 20 needed endotracheal ventilating immediately according to the exclusion criteria including severe respiratory acidosis （PaCO2 〉 60 mmHg）, cardiopulmonary arrest without effective resuscitation, severe congenital malformation and neonatal pulmonary hemorrhage. At the beginning, 104 neonatal infants who met the inclusion criteria were enrolled into the study and randomly divided into nIPPV group （ n = 50 ） and nCPAP group （ n = 54 ）, but 2 patients in nIPPV group moved out the NICU within 24 hours, and 1 patient in nCPAP group was diagnosed as severe congenital malformation, who were excluded from the study according to the exclusion criteria. Hence, the enrolled patients were 48 in nIPPV group and 53 in nCPAP group finally. Neonates treated with nIPPV and nCPAP had comparable clinical conditions in study entry. Infants treated initially with nIPPV needed less endotracheal ventilation than those treated with nCPAP （22.9% vs 37.7% , P 〈 0.05 ）. The blood gas analysis also showed that pH and PaO2 in nIPPV group were better than those in nCPAP group 1 hour after non-invasive respiratory support （P 〈 0.05, respectively）. However, there was no significant difference in the ratio of good outcomes （93.8% vs 86.8% , P 〉 0.05） between nIPPV group and nCPAP group. Conclusions Compared with nCPAP,nIPPV could decrease the requirement for endotracheal ventilation in neonatal infants with respiratory failure. The effect of nIPPV as a mode of initial non- invasive respiratory support needs further investigation.