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非侵入性神经调节通气辅助治疗早产儿:一项随机 II 期交叉试验。

Non-invasive neurally adjusted ventilatory assist in preterm infants: a randomised phase II crossover trial.

机构信息

Department of Paediatrics, Seoul National University Bundang Hospital, Kyeonggi, Korea.

Department of Paediatrics, Seoul National University Children's Hospital, Seoul, Korea.

出版信息

Arch Dis Child Fetal Neonatal Ed. 2015 Nov;100(6):F507-13. doi: 10.1136/archdischild-2014-308057. Epub 2015 Jul 15.

DOI:10.1136/archdischild-2014-308057
PMID:26178463
Abstract

OBJECTIVE

To compare non-invasive ventilation neurally adjusted ventilatory assist (NIV-NAVA) and non-invasive pressure support (NIV-PS) in preterm infants on patient-ventilator synchrony.

DESIGN

A randomised phase II crossover trial.

SETTING

Neonatal intensive care units of two tertiary university hospitals in Korea.

PATIENTS

Preterm infants born <32 weeks.

INTERVENTION

NIV-NAVA and NIV-PS were applied in random order after ventilator weaning. Data were recorded for sequential 5 min periods after 10 min applications of each mode.

MAIN OUTCOME MEASURES

The electrical activity of the diaphragm (Edi), ventilator flow and pressure curves were compared to examine the trigger delay (primary outcome) and other parameters of patient-ventilator interaction (secondary outcomes) for each period.

RESULTS

Fifteen infants completed the protocol. Trigger delay (35.2±8.3 vs 294.6±101.9 ms, p<0.001), ventilator inspiratory time (423.3±87.1 vs 534.0±165.5 ms, p=0.009) and inspiratory time in excess (32.3±8.3% vs 294.6±101.9%, p=0.001) were lower during NIV-NAVA compared with NIV-PS. Maximum Edi (12.6±6.3 vs 16.6±8.7 μV, p=0.003), swing Edi (8.8±4.8 vs 12.2±8.7 μV, p=0.012) and peak inspiratory pressure (12.3±1.5 vs 14.7±2.7 cm H2O, p=0.003) were also lower during NIV-NAVA. The main asynchrony events during NIV-PS were ineffective efforts and autotriggering. All types of asynchronies except double triggering were reduced with NIV-NAVA. Asynchrony index was significantly lower during NIV-NAVA compared with NIV-PS (p<0.001). No significant differences in leakage, expiratory tidal volume or minute ventilation were observed, but the respiratory rate was lower during NIV-PS than during NIV-NAVA.

CONCLUSIONS

NAVA improved patient-ventilator synchrony and diaphragmatic unloading in preterm infants during non-invasive nasal ventilation even in the presence of large air leaks.

TRIAL REGISTRATION NUMBER

Registered with http://www.clinicaltrials.gov (NCT01877720).

摘要

目的

比较神经调节辅助通气(NIV-NAVA)与压力支持通气(NIV-PS)在早产儿撤机后患者-呼吸机同步性方面的差异。

设计

随机、二期交叉临床试验。

地点

韩国两家三级大学医院的新生儿重症监护病房。

对象

胎龄<32 周的早产儿。

干预

在呼吸机脱机后,两种通气模式依次随机应用。在每种通气模式应用 10 min 后,连续记录 5 min 的数据。

主要观察指标

比较膈肌电活动(Edi)、呼吸机流量和压力曲线,以评估触发延迟(主要结局)和患者-呼吸机交互的其他参数(次要结局)。

结果

15 名婴儿完成了该方案。与 NIV-PS 相比,NIV-NAVA 时触发延迟(35.2±8.3 比 294.6±101.9 ms,p<0.001)、呼吸机吸气时间(423.3±87.1 比 534.0±165.5 ms,p=0.009)和吸气时间过长(32.3±8.3%比 294.6±101.9%,p=0.001)均较低。NIV-NAVA 时最大 Edi(12.6±6.3 比 16.6±8.7 μV,p=0.003)、摆动 Edi(8.8±4.8 比 12.2±8.7 μV,p=0.012)和吸气峰压(12.3±1.5 比 14.7±2.7 cm H2O,p=0.003)也较低。NIV-PS 时的主要失同步事件为无效触发和自动触发。除双重触发外,所有类型的失同步均减少。与 NIV-PS 相比,NIV-NAVA 时的失同步指数显著降低(p<0.001)。在漏气、潮气呼气量或分钟通气量方面没有显著差异,但在 NIV-PS 时呼吸频率低于 NIV-NAVA。

结论

在经鼻无创通气时,NAVA 可改善早产儿的患者-呼吸机同步性和膈肌减负作用,即使存在大量漏气也是如此。

试验注册号

在 http://www.clinicaltrials.gov 注册(NCT01877720)。

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