High Flow Nasal Oxygen Therapy in Pediatric Hypercapnic Respiratory Failure During Perioperative Stage
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- the number of patients in each group who require endotracheal intubation w
研究概览
简要总结
Humidified high flow nasal oxygen therapy decreases dilution of the inhaled oxygen and, by matching patient's peak flow, allows accurate delivery of the set FiO2 throughout the whole inspiratory phase.The purpose of this study is to determine the impact of hign-flow nasal therapy on pediatric hypercapnic respiratory failure by comparing with nasal continuous positive airway pressure.
详细描述
Humidified high flow nasal oxygen therapy decreases dilution of the inhaled oxygen and, by matching patient's peak flow, allows accurate delivery of the set FiO2 throughout the whole inspiratory phase.The purpose of this study is to determine the impact of hign-flow nasal therapy on pediatric hypercapnic respiratory failure by comparing with nasal continuous positive airway pressure
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 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ranges from 1 to 18 years
- •Hypercapnic respiratory failure:
- •PaO2<60mmHg and PaCO2 >50 mmHg
- •Candidate for non-invasive respiratory support as a result of:
- •an intention to manage the patient with non-invasive (no endotracheal tube) respiratory support
- •an intention to extubate the patient being managed with intubated respiratory support to non-invasive support
排除标准
- •Participation in a concurrent study that prohibits the use of HHFNC
- •Active air leak syndrome
- •Patients with abnormalities of the upper and lower airways; such as Pierre- Robin, Treacher-Collins, Goldenhar, choanal atresia or stenosis,
- •Patients with significant abdominal or respiratory malformations including tracheo-esophageal fistula, intestinal atresia, omphalocele, gastroschisis, and congenital diaphragmatic hernia
- •PaCO2<50mmHg
研究组 & 干预措施
High Flow Nasal Oxygen Therapy
Patients are randomized to the high flow nasal oxygen therapy group
干预措施: High Flow Nasal Oxygen Therapy (Device)
Nasal CPAP
Patients are randomized to the nasal continuous positive airway pressure treatment group
干预措施: Nasal CPAP (Device)
结局指标
主要结局
the number of patients in each group who require endotracheal intubation w
时间窗: 24 hours
次要结局
- mechanical ventilation-free to day 28(28 days)
研究者
Bin He
Associate Professor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine