Effect of Flow Rates of Postextubation High-flow Nasal Cannula on Extubation Outcome: An Open-label, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- A composite outcome of NIV(non-invasive ventilation) use or reintubation in 48 hours
研究概览
简要总结
This is a single-center, open-label, randomized controlled trial to evaluate the effect of high-flow nasal cannula with a flow rate of 60 L/min versus 40 L/min after planned extubationon on a composite outcome of reintubation and use of NIV.
详细描述
This is a single-center, open-label, randomized controlled trial to evaluate the effect of high-flow nasal cannula with a flow rate of 60 L/min versus 40 L/min after planned extubationon on a composite outcome of reintubation and use of NIV in patients who are intubated for hypoxemic respiratory failure.
[Study Procedures] Set flow rates of HFNC The flow rates of HFNC(high-flow nasal cannula) are set as 40 L/min and 60 L/min, respectively in the two trial groups. FiO2 was down-titrated to the minimal level to keep SO2 ≥ 92%. After that, the flow rate setting is fixed for 24hrs +/- 6 hrs in the two groups. After that, the flow rate setting in both groups would be tapered to 30 L/min and would be kept for 12 hours. Then, HFNC would be changed to conventional oxygen therapy to keep SpO2≥ 92%.
[Outcome Measures] To increase the statistical power of this pilot trial, we used a composite outcome of NIV use and or reintubation in 48 hours for the primary endpoint. Secondary endpoints include mortality of different time points, physiological parameters(respiratory rate, heart rate), ventilation/oxygenation data(PaO2/FiO2 ratio, pH) and patient comfort. Exploratory endpoints include comparison between different flow rate settings.
[Primary endpoint] We hypothesized that higher flow setting of HFNC can reduce work of breathing and can increase washout of dead space, which could result in lower re-intubation rate and lower NIV use rate after planned extubation in hypoxemic patients. The primary endpoint is a composite outcome of NIV use or reintubation in 48 hours between two groups of different flow rates.
[Secondary endpoints] ICU mortality In-hospital mortality 28-day mortality Time to successful liberation from mechanical ventilation AUC(area under curve) of respiratory rate (0-24 hours) AUC of heart rate (0-24 hours) PaO2/FiO2 ratio at 4 and 24 hours Change of arterial CO2 level(mmHg) at 4 and 24 hours Proportion of respiratory acidosis (arterial blood gas: pH<7.35) at 4 and 24 hours Proportion of Intolerance (up titration of flow or/and FiO2; down titration of flow) in 24 hours
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
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •invasive mechanical ventilation > 48 hours
- •acute hypoxemic respiratory failure(PaO2/FiO2 < 300 mmHg) as a main cause of invasive mechanical ventilation.
- •planned extubation & already passed a spontaneous breathing trial (SBT)
排除标准
- •< 20 years of ages
- •refusal to re-intubation
- •with terminal cancer
- •pregnant women
- •with a tracheal stoma or tracheostomy tube in situ
- •not feasible for high-flow nasal cannula(decided by the primary care team)
- •must required to use non-invasive ventilation immediately after extubation (decided by the primary care team)
结局指标
主要结局
A composite outcome of NIV(non-invasive ventilation) use or reintubation in 48 hours
时间窗: 48 hours after extubation
Proportion of patients require NIV(non-invasive ventilation) support or reintubation
次要结局
- Time to successful liberation from mechanical ventilation(28 days)
- AUC(area under curve) of respiratory rate (0-24 hours)(24 hours)
- Proportion of respiratory acidosis (arterial blood gas: pH<7.35) in 24 hours(24 hours)
- ICU mortality(ICU stay)
- In-hospital mortality(Hospital stay)
- 28-day mortality(28 days)
- Change of arterial CO2 level(mmHg) between 0 and 24th hour(24 hours)
- AUC of heart rate (0-24 hours)(24 hours)
- Change of PaO2/FiO2 ratio between 0 and 24th hour(24 hours)
- Proportion of Intolerance in 24 hours(24 hours)