Effect of Heliox on Infants With Respiratory Syncytial Virus Acute Bronchiolitis-A Revisit Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 主要终点
- Improvement in oxygenation
研究概览
简要总结
Helium is an inert gas with a density almost one-seventh of that of air. Based on its properties breathing a mixture of helium and oxygen (heliox) will lead to a reduction in resistance through narrowed airways and consequently decreases the work of breathing. Participating infants with RSV acute bronchiolitis will be supplied with heliox (ration of 21 oxygen and 79 helium) delivered through a flow nasal cannula to evaluate heliox effect in improving their oxygenation. Heliox will act as an additive therapy to improve oxygenation in patients with lower respiratory tract infection caused by respiratory Syncytial Virus (RSV) and will decrease the need for more complicated therapies.
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 Month 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age fro 1 month till 2 years
- •RSV acute bronchiolitis without any supplemental oxygen.
排除标准
- •oxygen supplement or mechanical ventilation requirement
- •congenital anomalies of the heart
- •chronic lung disease including bronchopulmonary dysplasia
- •Failure to obtain an informed consent.
研究组 & 干预措施
Heliox group
receive Helium oxygen mixture 21:79 via nasal cannula 2L/min
干预措施: Heliox (Drug)
Air group
receive oxygen 21%via nasal cannula 2L/min
干预措施: Air (Drug)
结局指标
主要结局
Improvement in oxygenation
时间窗: change from baseline at 24 hours after treatment
Arterial blood samples will be withdrawn through an arterial stab to determine partial pressure of arterial oxygen (PaO2)
次要结局
- improvement of respiratory distress(change from baseline at 24 hours after treatment)
研究者
Wael Seliem
Associated Professor
Mansoura University Children Hospital