Is Synchronization More Effective During Noninvasive Ventilation in Immediately Extubated Preterm Infants?
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- phasic esophageal pressure deflection
研究概览
简要总结
The purpose of this study is the examination of the hypothesis that synchronized nasal IMV as compared to non-synchronized nasal IMV will decrease breathing effort in preterm infants immediately after extubation when recovering from Respiratory distress syndrome (RDS).
Another objective is to examine the effects for synchronized non-invasive mechanical ventilation on gas exchange and cerebral oxygen saturation.
详细描述
In this study the investigators plan to test the hypothesis that synchronized nasal IMV (S-NIMV) as compared to non-synchronized nasal IMV (NIMV) will decrease breathing effort in preterm infants immediately after extubation when recovery from RDS, as measured by phasic esophageal pressure deflection.
Furthermore, the investigators plan to evaluate the effects of synchronized NIMV on gas exchange and brain oxygenation, and to evaluate the reliability of a newly developed abdominal pressure sensor device for the S-NIMV mode in a newly designed commercially available ventilator device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants recovering from respiratory failure with the following criteria were eligible for this study.
- •Gestational age <32 wks, those who are on invasive mechanical ventilation, recovering from RDS, and ready for extubation as judged by the clinical team.
- •Informed consent available.
排除标准
- •Infants with major congenital anomalies involving the CNS, lung (i.e. lung hypoplasia, active air leaks) or the heart (ASD, VSD allowed), or known neuromuscular disease.
结局指标
主要结局
phasic esophageal pressure deflection
时间窗: 4 hours
次要结局
- Cerebral oxygen saturation(4 hours)
- Arterial oxygen saturation(4 hours)
研究者
Prof. Dr. Helmut Hummler
Prof. Dr. Helmut Hummler
University of Ulm