Zhonghua Er Ke Za Zhi. 2014 Apr;52(4):271-6.
To assess the efficacy and safety of heated humidified high-flow nasal cannula (HHHFNC) ventilation compared with nasal continuous positive airway pressure (NCPAP) on prevention of extubation failure in the NICUs.
A prospective randomized, controlled un-blinded study was conducted in 12 tertiary hospitals in Hebei Province from December 1, 2012 to May 31, 2013. Neonates were eligible for this study if they were admitted to the participating NICUs within 7 days of postnatal age, and needed noninvasive respiratory support after a period of mechanical ventilation with an endotracheal tube. Infants were randomly assigned to either HHHFNC or NCPAP group. The primary outcome measures included: the incidence of extubation failure, bronchopulmonary dysplasia and the mortality before discharge.
Among the 255 cases included, 128 were in the HHHFNC group, and 127 were in the NCPAP group. There was no significant difference in gestational age, birth weight, and age at randomization, and male/female ratio between the two groups (P > 0.05). There were no significant differences between groups for days on ventilation, noninvasive respiratory support, oxygen requirement, hospital stay and time to full oral feedings (P > 0.05). The overall mortality of the studied population was 10.6% (27/255) . The occurrence of extubation failure within 7 days was 9.4% whereas 29.0% in very low birth weight infants. There was no significant difference in the extubation failure for HHHFNC (12/128, 9.4%) versus NCPAP (12/127, 9.4%) (P > 0.05), or in mortality for HHHFNC (12/128, 9.4%) versus NCPAP (15/127, 11.8%) (P > 0.05). No significant difference was found between the study groups in the occurrence of bronchopulmonary dysplasia (BPD) and most of severe adverse outcomes analyzed, including air leak syndrome and nasal trauma. The occurrence of abdominal distention during treatment was higher in NCPAP than HHHFNC group (12.6% vs. 5.5%, P < 0.05).
Among infants ≤ 7 d of postnatal age, HHHFNC appears to have efficacy and safety similar to those of NCPAP group when applied immediately post-extubation to prevent extubation failure. Despite concerns on unmonitored pressure delivery during HHHFNC support, no increase of the occurrence of BPD, air leak syndrome or mortality was found.
评估加热湿化高流量鼻导管(HHHFNC)通气与经鼻持续气道正压通气(NCPAP)在新生儿重症监护病房(NICUs)预防拔管失败方面的疗效和安全性。
2012年12月1日至2013年5月31日在河北省12家三级医院进行了一项前瞻性随机、非盲对照研究。出生后7天内入住参与研究的NICUs且在经气管插管机械通气一段时间后需要无创呼吸支持的新生儿符合本研究条件。婴儿被随机分为HHHFNC组或NCPAP组。主要结局指标包括:拔管失败发生率、支气管肺发育不良及出院前死亡率。
纳入的255例病例中,HHHFNC组128例,NCPAP组127例。两组在胎龄、出生体重、随机分组时的年龄及男女比例方面无显著差异(P>0.05)。两组在通气天数、无创呼吸支持、吸氧需求、住院时间及完全经口喂养时间方面无显著差异(P>0.05)。研究人群的总体死亡率为10.6%(27/255)。7天内拔管失败发生率为9.4%,极低出生体重儿中为29.0%。HHHFNC组(12/128,9.4%)与NCPAP组(12/127,9.4%)的拔管失败率无显著差异(P>0.05),HHHFNC组(12/128,9.4%)与NCPAP组(15/127,11.8%)的死亡率也无显著差异(P>0.05)。在支气管肺发育不良(BPD)的发生率以及所分析的大多数严重不良结局(包括气漏综合征和鼻外伤)方面,研究组之间无显著差异。治疗期间NCPAP组腹胀的发生率高于HHHFNC组(12.6%对5.5%,P<0.05)。
在出生后≤7天的婴儿中,拔管后立即应用HHHFNC预防拔管失败时,其疗效和安全性似乎与NCPAP组相似。尽管对HHHFNC支持期间压力输送未监测存在担忧,但未发现BPD、气漏综合征或死亡率增加。