Does High Flow Nasal Cannula Oxygen Therapy Prevent Reintubation in Pediatric Surgical Intensive Care Unit
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- reintubation rate
研究概览
简要总结
monocentric randomized controlled trial starting from Mars 2017, recruitment is still ongoing. Patients aged between 0-45 days needing mechanical ventilation (MV) with tracheal intubation were included random assignation in two groups for post-extubation management: Group Optiflow (GO) for patients receiving High Flow Nasal Cannula Oxygen Therapy HNFC and Control Group (CG) for conventional treatment.
Patients were evaluated during the first 72h following extubation. Primary endpoint was the incidence of reintubation. Secondary endpoints were incidence of post-extubation respiratory failure, time to reintubate and weaning time from oxygen. Respiratory and hemodynamic parameters were assessed and compared between the two groups upon extubation, after 2 hours (H2), at H6, H12, H24, H36, H48 and H72. Length of stay (LOS) and mortality were also estimated.
详细描述
We conducted a monocentric randomized controlled trial starting from Mars 2017, recruitment is still ongoing. Patients aged between 0-45 days needing mechanical ventilation (MV) with tracheal intubation were included regardless type of admission, severity of disease and randomly assigned in two groups for post-extubation management: Group Optiflow (GO) for patients receiving HNFC oxygen therapy and Control Group (CG) for conventional treatment. Before programmed extubation, newborns and young infants received 0.15 mg/kg of Dexamethasone. Patients were evaluated during the first 72h following extubation. Primary endpoint was the incidence of reintubation. Secondary endpoints were incidence of post-extubation respiratory failure, time to reintubate and weaning time from oxygen. Respiratory and hemodynamic parameters were assessed and compared between the two groups upon extubation, after 2 hours (H2), at H6, H12, H24, H36, H48 and H72. Length of stay (LOS) and mortality were also estimated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 45 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •need for mechanical ventilation
- •tracheal intubation
- •surgical intensive care admission
- •availability of extubation criteria
排除标准
- •prior extubation and mechanical ventilation to the actual episode
- •weaning failure due to neurological status
研究组 & 干预措施
Optiflow Group
high flow (6l/min), humidified oxygen administred into nasal cannula for post-extubation new born ventilated patients.
干预措施: High Flow Nasal Cannula Oxygen therapy (OPTIFLOW®) (Device)
Control Group
Conventional oxygen therapy for post extubation care
干预措施: Conventional oxygen therapy (Device)
结局指标
主要结局
reintubation rate
时间窗: 72 hours following prior weaning and extubation
need for mechanical ventilation support with tracheal intubation
次要结局
- incidence of post-extubation respiratory failure(72 hours following prior weaning and extubation)
- time to reintubate(72 hours following prior weaning and extubation)
- weaning time from oxygen.(72 hours following prior weaning and extubation)
- blood pressure(72 hours following prior weaning and extubation)
- heart rate(72 hours following prior weaning and extubation)
- respiratory rate(72 hours following prior weaning and extubation)
- SpO2/FiO2(72 hours following prior weaning and extubation)
研究者
Dr Sonia ben khalifa (PhD)
PROFESSOR
Hôpital d'enfants Béchir-Hamza