A Randomized controlled trial of heated humidified high flow nasal cannula flow of 1 lt/kg/min versus 2 lt/kg/min in management of children with moderate-severe respiratory distress
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 310
- 试验地点
- 1
- 主要终点
- To compare the efficacy of HFNC at 1lt/kg/min and 2lt/kg/min as assessed by failure rates with the two regimens within 24 hours
研究概览
简要总结
The Acute respiratory illnesses affect children worldwide but the incidence of severe ARI is highest in Africa and Southeastern Asia. these illness result in respiratory distress and poor feeding necessitating hospital admission. the provision of respiratory support in children with moderate to severe respiratory distress necessitates the use of supplemental oxygen to hypoxemic children and respiratory support in forM of CPAP, HFNC, NIV or invasive ventilation. HFNC provides heated humidified oxygen at high flows, reduces nasopharyngeal dead space, leads to CO2 washout and PEEP leading to improvement in parenchymal as well as airway diseases. the use of HFNC in paediatric practice has been studied in acute viral bronchiolitis , asthma, pneumonia, post extubation and in respiratory failure to avert the need for invasive ventilation.
so far, there are only 3 rct to study the impact of initial flow rate on failure rate in children, all of which focus on infants and children less than 2 years of age with bronchiolitis. there is no rct on effect of flow rate in older children and with indications other than bronchiolitis. so, we decided to conduct this study on the flow settings of hfnc in children less than 5 years of age with moderate to severe respiratory distress.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 1.00 Month(s) 至 5.00 Year(s)（—）
- 性别
- All
入选标准
- •with any of the following etiologies (bronchiolitis, bacterial/viral pneumonias, viral infection induced or multitriggered wheeze with respiratory distress) presenting with moderate-severe respiratory distress based on clinical respiratory score.
排除标准
- •children who have recieved hfnc at some other centre with hemodynamic instability requiring mechanical ventilation within 4 hours of admission those with comorbid condition such as congenital heart disease, chronic lung disease, known congenital lung or airway malformations, bronchopulmonary dysplasia , gastroesophageal reflux disease, immunodeficiency, pneumotjorax at presentation metabolic and neuromuscular diseases presenting with respiratory distress those with craniofacial anomalies or trauma.
结局指标
主要结局
To compare the efficacy of HFNC at 1lt/kg/min and 2lt/kg/min as assessed by failure rates with the two regimens within 24 hours
时间窗: To compare the efficacy of HFNC at 1lt/kg/min and 2lt/kg/min as assessed by failure rates with the two regimens within 24 hours
次要结局
- to compare the length of icu stay between two groups(from admission to discharge/shift to ward)
- to compare time to improvement in respiratory parameters between the two groups(from start of hfnc , 24 hours, at time of discharge from picu/shift to ward)
- to compare duration of hfnc between two groups(from admission to discharge from picu/shift to ward)
- to compare the need for invasive ventilation and mortality rate between two groups
研究者
Dr Umang
ESIC MCH, FARIDABAD