背景:无创通气(NIV)已被推荐为呼吸窘迫综合征(RDS)早产儿的最佳呼吸支持。然而,在RDS管理中用作第一意图的最佳NIV技术尚未建立。经鼻间歇性正压通气(NIPPV)可与婴儿的呼吸努力同步(SNIPPV)或非同步。该研究的目的是评估SNIPPV与NIPPV对心肺事件的影响,试图确定早产儿在第一次接受NIV通气支持时的最佳通气方式。
方法:设计了一项包含三个治疗阶段的无遮掩随机交叉研究。所有新生儿<32周胎龄的RDS需要NIV通气作为第一意图或拔管后将被连续纳入研究,并随机分配到NIPPV或SNIPPV组。稳定后,纳入的患者将交替使用两种不同的技术进行通气,每个通气时间为4小时。NIPPV和SNIPPV将使用相同的呼吸机和相同的接口进行管理,保持持续辅助通气,无患者不适。在整个研究期间,患者的心肺数据和呼吸机数据将使用连接到计算机的测谎仪同时记录。主要结果是氧饱和度降低的发作频率。次要结局是心肺事件的数量,FiO2的必要性,新生儿疼痛评分评估,同步索引,和胸腹异步。计算的样本量为30例患者。
结论:众所周知,由于呼吸机和婴儿呼吸之间的不同步,NIPPV会产生一定比例的无效行为。另一方面,无效的同步可能会增加呼吸功。我们的假设是,有效的同步可以减少呼吸功并增加每分钟交换的体积,而不会干扰RDS患者的自然呼吸节律。这项研究的结果将使我们能够评估同步的有效性,证明SNIPPV是否是RDS早产儿首次接受NIV通气时最有效的无创通气模式。
背景:ClinicalTrials.govNCT03289936。2017年9月21日注册。
BACKGROUND: Non-invasive ventilation (NIV) has been recommended as the best respiratory support for preterm infants with respiratory distress syndrome (RDS). However, the best NIV technique to be used as first intention in RDS management has not yet been established. Nasal intermittent positive pressure ventilation (NIPPV) may be synchronized (SNIPPV) or non-synchronized to the infant\'s breathing efforts. The aim of the study is to evaluate the short-term effects of SNIPPV vs. NIPPV on the cardiorespiratory events, trying to identify the best ventilation modality for preterm infants at their first approach to NIV ventilation support.
METHODS: An unmasked randomized crossover study with three treatment phases was designed. All newborn infants < 32 weeks of gestational age with RDS needing NIV ventilation as first intention or after extubation will be consecutively enrolled in the study and randomized to the NIPPV or SNIPPV arm. After stabilization, enrolled patients will be alternatively ventilated with two different techniques for two time frames of 4 h each. NIPPV and SNIPPV will be administered with the same ventilator and the same interface, maintaining continuous assisted ventilation without patient discomfort. During the whole duration of the study, the patient\'s cardiorespiratory data and data from the ventilator will be simultaneously recorded using a polygraph connected to a computer. The primary outcome is the frequency of episodes of oxygen desaturation. Secondary outcomes are the number of the cardiorespiratory events, FiO2 necessity, newborn pain score evaluation, synchronization index, and thoracoabdominal asynchrony. The calculated sample size was of 30 patients.
CONCLUSIONS: It is known that NIPPV produces a percentage of ineffective acts due to asynchronies between the ventilator and the infant\'s breaths. On the other hand, an ineffective synchronization could increase work of breathing. Our hypothesis is that an efficient synchronization could reduce the respiratory work and increase the volume per minute exchanged without interfering with the natural respiratory rhythm of the patient with RDS. The results of this study will allow us to evaluate the effectiveness of the synchronization, demonstrating whether SNIPPV is the most effective non-invasive ventilation mode in preterm infants with RDS at their first approach to NIV ventilation.
BACKGROUND: ClinicalTrials.gov NCT03289936 . Registered on September 21, 2017.