Randomised Controlled Trial Comparing Volume-targeted to Pressure-limited Ventilation in Infants Born at or Near Term
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Duration of mechanical ventilation
研究概览
简要总结
A randomised controlled trial comparing volume-targeted ventilation to pressure-limited ventilation in infants born at or near term.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Minute 至 4 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mechanically ventilated
- •Born at gestation 34 weeks and above
排除标准
- •Congenital diaphragmatic hernia
- •Congenital heart disease
研究组 & 干预措施
Pressure-limited ventilation
干预措施: Ventilation delivered by SLE5000 ventilator (Device)
Volume-targeted ventilation
干预措施: Ventilation delivered by SLE5000 ventilator (Device)
结局指标
主要结局
Duration of mechanical ventilation
时间窗: 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.
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.
次要结局
未报告次要终点