Pressure-limited Ventilation Versus Volume-targeted Ventilation in Term Newborns
Randomised Controlled Trial Comparing Volume-targeted to Pressure-limited Ventilation in Infants Born at or Near Term
研究概览
详细说明
Aims: There is increasing evidence that volume-targeted ventilation (VTV) holds benefits for preterm infants in comparison to pressure-limited ventilation. It is not known whether the same is true in the case of infants born at term. This study aims to compare pressure-limited to VTV in term-born infants.
Hypothesis: Volume-targeted will be associated with significantly earlier extubation compared to pressure-limited ventilation Primary outcome: Time to extubation. Methods: Ventilated infants 34 weeks or more gestational age at birth were recruited and randomly allocated to receive either pressure-limited or VTV. Adjustments to ventilator settings were made according to the trial protocol. Infants were deemed to have met failure criteria if they required HFOV or peak pressures of more than 30 cm of water. Analysis will be by intention-to-treat.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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London、英国、SE5 9RS
- King's College Hospital NHS Foundation Trust
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London、英国、SE5 9RS
- Neonatal intensive care unit
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Mechanically ventilated
- Born at gestation 34 weeks and above
Exclusion Criteria:
- Congenital diaphragmatic hernia
- Congenital heart disease
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：限压通气
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In pressure-limited ventilation arm, ventilator settings as required to maintain appropriate oxygenation and carbon-dioxide elimination. In volume-targeted ventilation arm, set target volume at 5ml/kg and wean rate. In both arms, aim to keep blood gases within normal limits. |
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有源比较器：容积目标通气
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In pressure-limited ventilation arm, ventilator settings as required to maintain appropriate oxygenation and carbon-dioxide elimination. In volume-targeted ventilation arm, set target volume at 5ml/kg and wean rate. In both arms, aim to keep blood gases within normal limits. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Duration of mechanical ventilation
大体时间：For each patient, the exact number of hours from the date and time of randomisation to the date and time of successful removal of the endotracheal tube, assessed up to 4 weeks.
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Data will be collected from the intensive care observation chart to determine the time at which the infant was successfully taken off of mechanical ventilation, assessed up to 4 weeks.
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For each patient, the exact number of hours from the date and time of randomisation to the date and time of successful removal of the endotracheal tube, assessed up to 4 weeks.
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合作者和调查者
调查人员
- 首席研究员：Anne Greenough, MD、King's College Hospital NHS Trust
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
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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