Effect of High-flow Nasal Oxygen vs Standard Oxygen Therapy on Extubation Outcome With High Risk of Extubation Failure in Medical ICU Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- reintubation rate
研究概览
简要总结
The purpose of this study is to determine whether high flow nasal cannula is effective in lowering the reintubation rate after extubation for high risk patients in medical intensive care unit
详细描述
The study hypothesis is that Optiflow may reduce the extubation failure rate for high risk patients in medical intensive care unit.In the intervention group, patients fulfilling inclusion criteria and not presenting any of the exclusion criteria will receive high-flow nasal cannula (Optiflow Airvo2, Fisher & Paykel Healthcare Ltd., New Zealand) after extubation. The oxygen concentration (FiO2) will be set to reach an oxygenation target similar to control patients (see below), while the gas flow rate will be set at 50 L/min.In the control group, patients fulfilling inclusion criteria and not presenting any of the exclusion criteria will receive standard oxygen therapy including nasal cannula or oxygen mask after extubation. The FiO2 will be set to obtain a arterial oxygen saturation (SpO2) between 92% and 98% (or between 88% and 95% in hypercapnic patients). NIPPV or intubation will be applied in both group if respiratory distress noted. High flow nasal cannula will be tried before NIPPV or intubation in the control group patients.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients mechanically ventilated for > 48 hours and at least one of the following:
- •> 65 y/o
- •Cardiac failure as the primary indication of mechanical ventilation
- •Bronchiectasis
- •Old pulmonary tuberculosis with destructive lung
- •Chronic renal failure
- •Neuromuscular disease
- •BMI > 30
- •Inability to manage respiratory secretions
排除标准
- •Presence of tracheostomy
- •Recent facial trauma
- •Active gastro-intestinal bleeding
- •Planned NIPPV support after extubation
研究组 & 干预措施
high flow nasal cannula
High flow nasal cannula immediately use after extubation
干预措施: high flow nasal cannula (Device)
stanrd oxygen therapy
Oxygen cannula or mask after extubation
干预措施: high flow nasal cannula (Device)
结局指标
主要结局
reintubation rate
时间窗: 72 hours after extubation
次要结局
- Need for Non-Invasive Ventilation(at day 28 after inclusion in the study)
- ICU readmission rate due to respiratory failure(at day 28 after inclusion in the study)
- ICU mortality rate(at day 28 after inclusion in the study)
- ICU length of stay(at day 28 after inclusion in the study)
- Hospital mortality(at day 28 after inclusion in the study)
- Hospital length of stay(at day 28 after inclusion in the study)
- Nosocomial pneumonia rate(at day 28 after inclusion in the study)
- Desaturation ( SaO2< 90%)(72 hours after extubation)
- Severe hypoxemia (PaO2/Fraction of inspired O2 < 200)(Time Frame: 72 hours after extubation)
- hypercapnia (PaCO2 > 50)(72 hours after extubation)
- respiratory acidosis (arterial pH < 7.30)(72 hours after extubation)
- severe tachypnea (>40/min)(72 hours after extubation)