Objective

To characterize respiratory function monitor (RFM) measurements of sustained inflations and intermittent positive pressure ventilation (IPPV) delivered noninvasively to infants in the Sustained Aeration of Infant Lungs (SAIL) trial and to compare vital sign measurements between treatment arms.

Study design

We analyzed RFM data from SAIL participants at 5 trial sites. We assessed tidal volumes, rates of airway obstruction, and mask leak among infants allocated to sustained inflations and IPPV, and we compared pulse rate and oxygen saturation measurements between treatment groups.

Results

Among 70 SAIL participants (36 sustained inflations, 34 IPPV) with RFM measurements, 40 (57%) were spontaneously breathing prior to the randomized intervention. The median expiratory tidal volume of sustained inflations administered was 5.3 mL/kg (IQR 1.1-9.2). Significant mask leak occurred in 15% and airway obstruction occurred during 17% of sustained inflations. Among 34 control infants, the median expiratory tidal volume of IPPV inflations was 4.3 mL/kg (IQR 1.3-6.6). Mask leak was present in 3%, and airway obstruction was present in 17% of IPPV inflations. There were no significant differences in pulse rate or oxygen saturation measurements between groups at any point during resuscitation.

Conclusion

Expiratory tidal volumes of sustained inflations and IPPV inflations administered in the SAIL trial were highly variable in both treatment arms. Vital sign values were similar between groups throughout resuscitation. Sustained inflation as operationalized in the SAIL trial was not superior to IPPV to promote lung aeration after birth in this study subgroup.

Trial Registration

Clinicaltrials.gov: NCT02139800.

中文翻译：

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早产儿出生时持续充气与间歇性正压通气：呼吸功能和生命体征测量

客观的

描述持续通气和间歇性正压通气 (IPPV) 在婴儿肺持续通气 (SAIL) 试验中无创地输送给婴儿的呼吸功能监测器 (RFM) 测量值，并比较治疗组之间的生命体征测量值。

学习规划

我们分析了来自 5 个试验地点的 SAIL 参与者的 RFM 数据。我们评估了分配给持续充气和 IPPV 的婴儿的潮气量、气道阻塞率和面罩漏气率，并且我们比较了治疗组之间的脉搏率和氧饱和度测量值。

结果

在进行 RFM 测量的 70 名 SAIL 参与者（36 名持续通气，34 名 IPPV）中，40 名 (57%) 在随机干预前自主呼吸。持续充气的中位呼气潮气量为 5.3 mL/kg (IQR 1.1-9.2)。15% 发生严重面罩泄漏，17% 持续充气期间发生气道阻塞。在 34 名对照婴儿中，IPPV 通货膨胀的中位呼气潮气量为 4.3 mL/kg (IQR 1.3-6.6)。3% 存在面罩泄漏，17% 的 IPPV 充气存在气道阻塞。在复苏期间的任何时间点，各组之间的脉搏率或氧饱和度测量值均无显着差异。

结论

在 SAIL 试验中进行的持续充气和 IPPV 充气的呼气潮气量在两个治疗组中变化很大。在整个复苏过程中，各组之间的生命体征值相似。在本研究亚组中，SAIL 试验中实施的持续充气在促进出生后肺通气方面并不优于 IPPV。

试用注册

临床试验.gov：NCT02139800。