High Flow Nasal Cannula Versus Standard Oxygen Therapy in Children With Status Asthmaticus: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 272
- 试验地点
- 14
- 主要终点
- Number of patients with first line treatment Failure as defined below in the first 24 hours
研究概览
简要总结
In France, over 2.5 million people suffer from asthma, including one-third of children. This is the chronic respiratory disease leading to the highest rate of hospitalization. The conventional oxygen delivery means in children are the non-rebreather face mask or low flow nasal cannula (standard oxygen therapy - SOT). New non-invasive ventilatory support systems such as High Flow Nasal Cannula (HFNC) are emerging. These are nasal cannulas allowing the delivery of a high air (or oxygen) flow, exceeding the inspiratory flow of patients with acute respiratory failure, allowing to deliver a slight positive expiratory pressure while ensuring humidification and warming of the airways. Aerosol administration is also possible with excellent efficiency and without interrupting respiratory assistance. Physiological data and clinical studies in other pathologies suggest the interest of this technique during the asthma attack, but no comparative study currently exists in this indication. The HFNCs could have their place upstream of Non Invasive Ventilation (NIV), thus replacing non-rebreather face mask sometimes not tolerated by the children. The investigators's hypothesis is that HFNCs could improve patients' health faster, reduce the use of other ventilatory assistance (NIV, invasive ventilation) and reduce the duration of hospitalization in intensive care units or continuous monitoring units (CMU).
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
- 6 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 6 months and <18 years old
- •Hospitalized in PICU with status asthmaticus defined by
- •a PRAM score > 7 with no response at H2 to the conventional treatment according to the GINA (Global Initiative for Asthma guidelines) protocol: Oxygen therapy, Continuous nebulization of beta2 agonist for at least one hour then every hour, Oral or intravenous corticosteroid (ie methylprednisolone 2mg/kg/j)
- •or with hypercapnic acidosis (pCO2 > 45 mmHg and pH < 7,35)
- •Informed consent signed by at least on parent or legal guardians prior to inclusion and oral consent of the other parent if absent
排除标准
- •Non-corrected congenital heart disease, or neuromuscular disease, or chronic respiratory disease (pulmonary or bronchial fibrosis, cystic fibrosis), or ENA disease (laryngo or tracheo malacia), scoliosis or chronic metabolic disease
- •Need for non-invasive or invasive ventilation (Glasgow comas scale <8, hemodynamic instability, refractory hypoxemia, cardiac arrest)
- •Pneumothorax confirmed on the X-ray
- •No national health coverage
结局指标
主要结局
Number of patients with first line treatment Failure as defined below in the first 24 hours
时间窗: up to hour 24
First line treatment Failure in the first 24 hours is defined as: * Occurrence or worsening of hypercapnic acidosis (pH\<7.35 with pCO2\>45 mmHg) * Or worsening of PRAM score (\>=2 from baseline) * Or SpO2\<92% with maximal flow of oxygen depending on age in the group standard oxygen therapy or with FiO2 \> 60% associated with a flow between 1 and 3L/Kg/min in the HFNC group * Or occurrence or worsening of the level of consciousness with Glasgow coma scale \< 12 * Or the need of invasive or noninvasive ventilation (Glasgow coma scale\<8, hemodynamic instability, refractory hypoxemia) at any time during the first 24 hours
次要结局
- total number of hours of PICU stay(month 1)
- Cumulative dose of treatments (salbutamol, corticosteroid magnesium sulfate)(month 1)
- Number of Patients requiring noninvasive ventilation (NIV)(month 1)
- Number of Patients requiring invasive ventilation (IV).(month 1)
- Duration of invasive ventilation (IV).(month 1)
- Duration of noninvasive ventilation (NIV)(month 1)
- Comfort assessed by the FLACC score(up to hour 24)
- Time from inclusion to restoration of a PRAM score < 8 (in hours).(month 1)
- Time from inclusion to blood gas normalization (pCO2<45 mmHg and pH>7.35) if available (hours)(month 1)
- Duration of supplemental oxygen therapy (in hours)(month 1)