Interest of High Flow Nasal Cannula (HFNC) Versus Non Invasive Ventilation During the Initial Management of Severe Bronchiolitis in Infants
试验速览
- 阶段
- 不适用
- 入组人数
- 142
- 试验地点
- 2
- 主要终点
- Proportion of failure
研究概览
简要总结
- The purpose of the study is to evaluate prospectively the clinical benefits of High flow nasal canula (HFNC: 2l/kg/min) versus nasal CPAP( continuous positive airway pressure) (n-CPAP: 7 cmH2O) in the initial management of bronchiolitis in infants.
- Design: non-inferiority study, prospective, controlled, randomized, multi-center.
- Design: Infants less than 6 month admitted in pediatric intensive care unit for respiratory distress (mWCAS >3) secondary to bronchiolitis but not requiring mechanical ventilation will be randomized in two groups: "n-CPAP"(nasal continuous positive airway pressure) or "HFNC" during 24 hours.
- Conditions of measurements:
Primary endpoint: Proportion of failure in both arms during the first 24 hours. Failure criteria: A raise of the Clinical score for respiratory distress (mWCAS) (1 point) or respiratory rate (10/min /H0 and above 60/min) or discomfort (EDIN) (1point /H0 and above 4) or apnea.
Secondary outcomes: Assessment at H1, H12, H24 of mWCAS, respiratory and heart rate, EDIN score, skin lesions, FiO2 (fraction of inspired oxygen
) required to achieve an oxygen saturation between 94 and 97%, transcutaneous PCO2 (carbon dioxide partial pressure) (correlated to an initial gas analysis), Report SpO2 / FiO2 5. Statistic: Intention to treat Analysis. Expected number of patients: 71 per arm: 142 children. 6. Study Schedule: October 2014-April 2016
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 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age<6months
- •bronchiolitis
- •mWCAS > or=3
- •hospitalisation in pediatric intensive care unit
- •signed consent form (2 parents)
排除标准
- •Intubated patient
- •Neurological or cardiac disease
结局指标
主要结局
Proportion of failure
时间窗: 24 hours
Proportion of failure in both arms during the first 24 hours. A raise of the Clinical score for respiratory distress (mWCAS) (1 point) or respiratory rate (10/min /H0 and above 60/min) or discomfort (EDIN) (1point /H0 and above 4) or apnea.
次要结局
- number of participants with an aggravation of the clinical score for respiratory distress arms(12hours)
- Comparison of the Report Sp02/Fi02 in both arms(24 hours)
- number of participants with skin lesions in both arms(24 hours)
- number of participants with an increase of the clinical score for respiratory distress arms(1 hour)
- number of participants with Discomfort in both arms(24 hours)