Is Synchronization More Effective During Noninvasive Ventilation in Immediately Extubated Preterm Infants? (N_SIMV)
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.
研究概览
详细说明
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.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Baden-Wüttemberg
-
Ulm、Baden-Wüttemberg、德国、89075
- 招聘中
- Children's Hospital University of Ulm
-
首席研究员：
- Helmut Hummler, Prof. Dr
-
-
参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
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.
Exclusion Criteria:
• 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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：S-nIMV
nIMV synchronized using abdominal pressure capsule sensor device
|
Synchronization of nasal breaths to infant's own respiratory effort
|
|
安慰剂比较：nIMV
non-synchronized nasal intermittent mandatory ventilation group
|
Synchronization of nasal breaths to infant's own respiratory effort
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
phasic esophageal pressure deflection
大体时间：4 hours
|
4 hours
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Cerebral oxygen saturation
大体时间：4 hours
|
4 hours
|
|
Arterial oxygen saturation
大体时间：4 hours
|
4 hours
|
合作者和调查者
调查人员
- 首席研究员：Hummler Helmut, Prof. Dr、University of Ulm
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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