Comparison of High Flow Oxygenation Therapy and CPAP in Children With Bronchiolitis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- respiration rate
研究概览
简要总结
Bronchiolitis in infants and young children often requires respiraty support. In Denmark Continous Positive Airway Pressure ( CPAP) are routinely used in children with moderate-severe bronchiolitis. The aim of the study is to compare CPAP and High Flow Oxygenation Therapy (HFOT) as tools of respiratory support in infants and young children with bronchiolitis.
Infants and young children with moderate-severe bronchiolitis and are randomized to either CPAP or HFOT.
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 Day 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •infants and children with moderate respiratoric syncytial virus bronchiolitis or other viral bronchiolitis and need of respiratory support. ( clinical decision)
排除标准
- •severe bronchiolitis with P C02 > 9, decreased consciusness and risk for early progression to intensive therapy.
结局指标
主要结局
respiration rate
时间窗: after 6 12 18 24 and 48 hour of intervention
change in respiration rate ( RR) from preintervention value
Modified asthma score (MWAS)
时间窗: Once daily as long as intervention precedes ( 1-14 days)
Change in MWAS from pre intervention value
PCo2
时间窗: after 6 12 24 and 48 hours of intervention
Change in PCo2 (partial pressure of carbon dioxide)from pre intervention value
次要结局
- treatment length(from beginning of intervention to discontinuation (1-14 days))
- Intervention failure.(from beginning of intervention to discontinuation.(1-14 days))
- patient acceptance of intervention(daily VAS score (0-5) from beginning of intervention to discontinuation (1-14 days))
- Hspitalization(from hospitalization to release (1-21 days))
研究者
Signe Voss Vahlkvist
MD PhD
Esbjerg Hospital - University Hospital of Southern Denmark