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临床试验/NCT02770976
NCT02770976已完成不适用

Respiratory Pattern During Neurally Adjusted Ventilator Assist (NAVA) in Preterm Infants

Inha University Hospital2 个研究点 分布在 2 个国家目标入组 14 人开始时间: 2016年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
2
主要终点
maximum Edi

研究概览

简要总结

This study is to investigate the effect of a wide range of assistance levels on respiratory pattern, breathing variability including tidal volume and peak inspiratory pressure during neurally adjusted ventilatory assist (NAVA) in preterm infants. The investigators also aim to explore whether the effects of NAVA on the electrical activity of diaphragm (Edi) signal amplitude, work of breathing and comfort of preterm infants.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • preterm infants born before 36 weeks of gestational age
  • who received mechanical ventilatory care through the endotracheal tube at least 24 hours for respiratory distress
  • no use of anesthetics or analgetics

排除标准

  • with major congenital anomalies (facial, gastrointestinal tract, cardiac, etc)
  • with phrenic nerve palsy or injuries

结局指标

主要结局

maximum Edi

时间窗: the middle 2 minutes duration out of the total interval of 10 minutes

mean of recorded maximum electrical activities in the middle 2 min duration out of the total 10 min period

次要结局

  • peak inspiratory pressure(the middle 2 minutes duration out of the total interval of 10 minutes)
  • tidal volume(the middle 2 minutes duration out of the total interval of 10 minutes)
  • electrical time product(the middle 2 minutes duration out of the total interval of 10 minutes)
  • inspiratory time in excess(the middle 2 minutes duration out of the total interval of 10 minutes)
  • comfort score(the 5-min point in the total 10-min period)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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