跳至主要内容
临床试验/NCT02849054
NCT02849054Unknown不适用

Optimisation of Neonatal Ventilation: Congenital Diaphragmatic Hernia - Determining the Appropriate Level of Volume Guarantee

King's College London2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2016年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
18
试验地点
2
主要终点
Change in Pressure Time Product of the diaphragm (PTPdi) at different levels of targetted tidal volume

研究概览

简要总结

To determine the appropriate volume (size) of ventilator breath during volume-targetted ventilation for infants born with congenital diaphragmatic hernia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
— 至 6 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Congenital diaphragmatic hernia - post-operative Mechanically ventilated Born at >34/40

排除标准

  • neuromuscular blockade contraindications to NG/OG tube insertion

研究组 & 干预措施

4, 5, 6ml/kg targetted tidal volume

Experimental

Randomised to receive TTV at 4ml/kg, 5ml/kg, 6ml/kg. Measurement of PTPdi

干预措施: Measurement of PTPdi (Device)

4, 5, 6ml/kg targetted tidal volume

Experimental

Randomised to receive TTV at 4ml/kg, 5ml/kg, 6ml/kg. Measurement of PTPdi

干预措施: TTV at 4ml/kg (Device)

4, 5, 6ml/kg targetted tidal volume

Experimental

Randomised to receive TTV at 4ml/kg, 5ml/kg, 6ml/kg. Measurement of PTPdi

干预措施: TTV at 5ml/kg (Device)

4, 5, 6ml/kg targetted tidal volume

Experimental

Randomised to receive TTV at 4ml/kg, 5ml/kg, 6ml/kg. Measurement of PTPdi

干预措施: TTV at 6ml/kg (Device)

4, 6, 5ml/kg targetted tidal volume

Experimental

Randomised to receive TTV at 4ml/kg, 6ml/kg, 5ml/kg. Measurement of PTPdi

干预措施: Measurement of PTPdi (Device)

4, 6, 5ml/kg targetted tidal volume

Experimental

Randomised to receive TTV at 4ml/kg, 6ml/kg, 5ml/kg. Measurement of PTPdi

干预措施: TTV at 4ml/kg (Device)

4, 6, 5ml/kg targetted tidal volume

Experimental

Randomised to receive TTV at 4ml/kg, 6ml/kg, 5ml/kg. Measurement of PTPdi

干预措施: TTV at 5ml/kg (Device)

4, 6, 5ml/kg targetted tidal volume

Experimental

Randomised to receive TTV at 4ml/kg, 6ml/kg, 5ml/kg. Measurement of PTPdi

干预措施: TTV at 6ml/kg (Device)

5, 4, 6ml/kg targetted tidal volume

Experimental

Randomised to receive TTV at 5ml/kg, 4ml/kg, 6ml/kg. Measurement of PTPdi

干预措施: Measurement of PTPdi (Device)

5, 4, 6ml/kg targetted tidal volume

Experimental

Randomised to receive TTV at 5ml/kg, 4ml/kg, 6ml/kg. Measurement of PTPdi

干预措施: TTV at 4ml/kg (Device)

5, 4, 6ml/kg targetted tidal volume

Experimental

Randomised to receive TTV at 5ml/kg, 4ml/kg, 6ml/kg. Measurement of PTPdi

干预措施: TTV at 5ml/kg (Device)

5, 4, 6ml/kg targetted tidal volume

Experimental

Randomised to receive TTV at 5ml/kg, 4ml/kg, 6ml/kg. Measurement of PTPdi

干预措施: TTV at 6ml/kg (Device)

5, 6, 4ml/kg targetted tidal volume

Experimental

Randomised to receive TTV at 5ml/kg, 6ml/kg,4ml/kg. Measurement of PTPdi

干预措施: Measurement of PTPdi (Device)

5, 6, 4ml/kg targetted tidal volume

Experimental

Randomised to receive TTV at 5ml/kg, 6ml/kg,4ml/kg. Measurement of PTPdi

干预措施: TTV at 4ml/kg (Device)

5, 6, 4ml/kg targetted tidal volume

Experimental

Randomised to receive TTV at 5ml/kg, 6ml/kg,4ml/kg. Measurement of PTPdi

干预措施: TTV at 5ml/kg (Device)

5, 6, 4ml/kg targetted tidal volume

Experimental

Randomised to receive TTV at 5ml/kg, 6ml/kg,4ml/kg. Measurement of PTPdi

干预措施: TTV at 6ml/kg (Device)

6, 5, 4ml/kg targetted tidal volume

Experimental

Randomised to receive TTV at 6ml/kg, 5ml/kg, 4ml/kg. Measurement of PTPdi

干预措施: Measurement of PTPdi (Device)

6, 5, 4ml/kg targetted tidal volume

Experimental

Randomised to receive TTV at 6ml/kg, 5ml/kg, 4ml/kg. Measurement of PTPdi

干预措施: TTV at 4ml/kg (Device)

6, 5, 4ml/kg targetted tidal volume

Experimental

Randomised to receive TTV at 6ml/kg, 5ml/kg, 4ml/kg. Measurement of PTPdi

干预措施: TTV at 5ml/kg (Device)

6, 5, 4ml/kg targetted tidal volume

Experimental

Randomised to receive TTV at 6ml/kg, 5ml/kg, 4ml/kg. Measurement of PTPdi

干预措施: TTV at 6ml/kg (Device)

6, 4, 5ml/kg targetted tidal volume

Experimental

Randomised to receive TTV at 6ml/kg, 4ml/kg, 5ml/kg. Measurement of PTPdi

干预措施: Measurement of PTPdi (Device)

6, 4, 5ml/kg targetted tidal volume

Experimental

Randomised to receive TTV at 6ml/kg, 4ml/kg, 5ml/kg. Measurement of PTPdi

干预措施: TTV at 4ml/kg (Device)

6, 4, 5ml/kg targetted tidal volume

Experimental

Randomised to receive TTV at 6ml/kg, 4ml/kg, 5ml/kg. Measurement of PTPdi

干预措施: TTV at 5ml/kg (Device)

6, 4, 5ml/kg targetted tidal volume

Experimental

Randomised to receive TTV at 6ml/kg, 4ml/kg, 5ml/kg. Measurement of PTPdi

干预措施: TTV at 6ml/kg (Device)

结局指标

主要结局

Change in Pressure Time Product of the diaphragm (PTPdi) at different levels of targetted tidal volume

时间窗: 3 hours

PTPdi will be measured at each level of tidal volume. The outcome measure is the change in PTPdi.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验