High Flow Oxygen Therapy vs Standard Care in Infants With Viral Bronchiolitis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Effect of high flow humidified oxygen therapy on blood oxygen saturations
研究概览
简要总结
A randomized control trial of 130 infants admitted to the paediatric high care admission ward will be enrolled, and randomized to either "high flow humidified oxygen" or "standard therapy".
详细描述
A randomized control trial of 130 infants admitted to the paediatric high care admission ward will be enrolled. Infants between 1 month and 2 years of age who fulfill criteria for enrollment shall be considered eligible. Informed consent from parents or legal guardians shall be obtained. Infants shall be randomized to either "standard therapy" or "high flow humidified oxygen". Measurements of heart rate, respiratory rate, work of breathing (Tal score and WCAS), oxygen saturation and oxygen requirements shall be recorded.
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
- •Clinical diagnosis of viral bronchiolitis
- •Not requiring intubation and ventilation
- •Admitted to high care unit
- •With moderate/severe respiratory distress (Tal score >6)
- •Saturations <92% in room air
排除标准
- •congenital cardiac disease
- •presence of multiorgan failure/multisystemic disease
- •previously ventilated
- •craniofacial abnormalities
- •nasal pathology
- •decreased level of consciousness
- •Ex-prem <34 weeks
- •Possible impending respiratory failure
结局指标
主要结局
Effect of high flow humidified oxygen therapy on blood oxygen saturations
时间窗: first 5 days post enrollment
Saturation of oxygen (% saturation) as measured by pulse oximeter
Effect of high flow humidified oxygen therapy on work of breathing
时间窗: first 5 days post enrollment
Use of accessory muscles of respiration (present /not)
Effect of high flow humidified oxygen therapy on heart rate
时间窗: first 5 days post enrollment
Pulse (n/min) measured by ECG monitor
次要结局
- Length of hospital stay(from time of enrollment to end of hospital stay (up to 6 months))
- Proportion of patients requiring intubation and ventilation(from time of enrollment to end of hospital stay (up to 6 months))
研究者
Susan Murphy
Specialist Intensivist
Chris Hani Baragwanath Academic Hospital