High Flow Nasal Cannula Therapy (HFNC) Versus Nasal Positive Airway Pressure and or Nasal Positive Pressure Ventilation (NCPAP/ NPPV) in Infants With Severe Bronchiolitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 268
- 主要终点
- Number of participants with HFNC success
研究概览
简要总结
The purpose of the study was to test the null hypothesis that there is no difference between nasal continuous positive airway pressure / nasal positive pressure ventilation (NCPAP/NPPV) and high flow nasal cannula (HFNC) devices when applied as a first non-invasive respiratory support mode for severe bronchiolitis
详细描述
The authors conducted a randomized controlled trial in the PICU of Children's hospital of Tunis. Participants aged from 7 days to 6 months, were eligible if all inclusion criteria were verified.
On admission, demographic and clinical data were collected. When a participant met the inclusion criteria, respiratory support was randomly allocated as high flow nasal cannula (HFNC) or nasal continuous positive airway pressure / nasal positive pressure ventilation (CPAP/NPPV).
Clinical parameters were monitored at treatment start and every 6 hours during the first 24 hours and then twice daily thereafter.
Participants in the HFNC group received heated and humidified gas flow with the Fisher & Paykel Healthcare HFNC system. The flow rate was usually started at the maximum flow rate for the size of cannula and a constant flow temperature of 37 °C.The flow rate will be progressively decreased when inspired fraction of oxygen (FiO2) was inferior to 30 percent (%).
Participants in the CPAP/NPPV group received for first CPAP using a neonatal ventilator. The recommended starting pressure for CPAP was +6 centimeter of water (cmH2O). Positive continuous pressure could be increased to a maximum of +8 cmH2O. Optimal positive end expiratory pressure (PEEP) was what could maintain SpO2 at 94 per cent using the lowest fraction of inspired oxygen. PEEP will be decreased progressively of 1cmH2O every 6 hours from the optimal PEEP when FiO2 was inferior to 30% and there is no increased work of breathing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 7 Days 至 6 Months(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of bronchiolitis defined as the first viral episode of respiratory distress before 2 years of aging, presenting with rhinitis, tachypnea, cough, wheezing, prolonged expiratory time, crackles and use of accessory muscles, with or without fever, with or without infiltrate on the chest X ray
- •bronchiolitis severity Wang modified score ≥ 10
排除标准
- •recurrent wheezing
- •heart disease
- •chronic lung disease
- •neuromuscular disease
- •primary diagnosis was not bronchiolitis (pneumonia, pertussis)
- •critically ill infants who had an immediate need of intubation
结局指标
主要结局
Number of participants with HFNC success
时间窗: during hospitalization, approximatly 6 days
success was defined by no need of another respiratory support device
Number of participants with CPAP/NPPV success
时间窗: during hospitalization, approximatly 6 days
success was defined by no need of another support device
次要结局
- rate of intubation(during hospitalization, approximatly 6 days)
研究者
Aida Borgi
Professor
Children's Hospital of Tunis
