High Flow Nasal Cannula Weaning in Acute Bronchiolitis - an Open-label Randomized Controlled Trials
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Hospitalization time from randomization
研究概览
简要总结
The goal of this clinical study is to compared two different strategies to end high flow nasal cannula treatment in acute bronchiolitis. This study compared the immediate ending of high flow treatment to weaning strategy, in which the flow rate is gradually decreased. The aim is to assess if the immediate ending shortens the hospitalization time and whether it is a safe strategy.
详细描述
Acute bronchiolitis is the most common cause of hospitalization among infants in Finland, with its primary etiology being the RS- virus. Acute bronchiolitis is defined in Finland as an infant's first respiratory distress before the age of 1. There is no effective pharmacological treatment for acute bronchiolitis. High-flow nasal cannula therapy has been shown in large randomized trials to reduce the risk of intensive care unit admission for children. High-flow nasal cannulas are typically used at a flow rate of 2 liters per kilogram per minute. Despite widespread use, there is insufficient evidence to determine whether high-flow therapy should be discontinued abruptly or gradually tapered. Observational studies indicate that the majority of units opt for abrupt discontinuation. Common criteria for discontinuation include weaning off supplemental oxygen and maintaining normal oxygenation on room air for 4-6 hours. Gradual weaning has been shown in observational studies to prolong hospitalization compared to immediate cessation of therapy. In a randomized controlled trial conducted in a pediatric intensive care unit, direct discontinuation shortened the duration of treatment by up to two days. However, there have been no previous randomized trials conducted on bronchiolitis patients.
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
- 0 Months 至 12 Months(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically diagnosed acute bronchiolitis
- •High flow nasal cannula treatment has lasted for at least 12 hours
- •Measured saturation 95 or more with room air
- •High flow rate is maximum 2l/kg/min
- •The treating doctors considers the infant suitable to be without high flow
排除标准
- •Major congenital anomaly of lungs, hearts or diaphragm
- •Bacterial pneumonia
- •Parents do not give consent
结局指标
主要结局
Hospitalization time from randomization
时间窗: One week
Time in hours from the randomization to the time the family leaves hospital.
次要结局
- Overall hospitalization time(One week)
- Treatment failures(One week)
- Readmission rate(Seven days from discharge)
研究者
Ilari Kuitunen
Associate Professor
Kuopio University Hospital
