Effects of Face Mask Continuous Positive Airway Pressure Vs. Noninvasive Ventilation Vs. High-flow Nasal Oxygen on Intubation-free Survival in Acute Hypoxemic Respiratory Failure: the TRIPOD Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,300
- 试验地点
- 1
- 主要终点
- Intubation-free survival rate
研究概览
简要总结
Acute hypoxemic respiratory failure (AHRF) is a common indication for admission to an intensive care unit (ICU), with mortality exceeding 50% in cases where invasive mechanical ventilation is needed. Therefore, assessment of the most adequate oxygen strategy to avoid intubation in patients with AHRF deserves consideration.Previous studies have indicated that non-invasive oxygenation strategies, including high-flow nasal oxygen (HFNO), helmet or face mask noninvasive ventilation (NIV), and continuous positive airway pressure (CPAP), are effective in preventing endotracheal intubation in adult patients with AHRF when compared to the standard oxygen therapy. However, the optimal non-invasive oxygenation strategies remain uncertain. This study aim to determine whether CPAP, compared with HFNC or NIV, increase the intubation-free survival during study period in patients with AHRF.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≥18 yrs;
- •A ratio of the partial pressure of arterial oxygen (PaO2) to the FiO2 of 300 mm Hg or less, or a ratio of pulse oximetry oxygen saturation (SpO2) to the FiO2 of 315 or less (SpO2≤97%) and the need for (1) noninvasive positive pressure ventilation with at least 5 cm H2O PEEP, or (2) high-flow nasal cannula at 30L/min or higher, or (3) standard oxygen with oxygen flow rate of at least 10 L/min;
- •Sign informed consent.
排除标准
- •Patients that have already received Continuous positive airway pressure, Noninvasive ventilation continuously for more than 24 hours before the screening visit.
- •Previous bout of mechanical ventilation during index hospitalization.
- •Exacerbation of chronic lung disease, including asthma or chronic obstructive pulmonary disease.
- •Moderate to severe cardiac insufficiency (New York Heart Association class >II or left ventricular ejection fraction<50%) or cardiogenic pulmonary edema.
- •Hemodynamic dysfunction, defined as vasopressor dose > 0.3 µg/kg/min of norepinephrine-equivalent to maintain systolic blood pressure > 90 mm Hg.
- •Impaired consciousness with a Glasgow coma score ≤
- •Patients with urgent need for intubation, including respiratory or cardiac arrest, respiratory pauses with loss of consciousness or gasping for air, severe hypoxemia defined as SpO2 lower than 90% despite maximal oxygen support.
- •Patients with contraindication to NIV according to the French consensus conference, patient refusal, cardiorespiratory arrest, coma, non-drained pneumothorax, unresolved vomiting, upper airway obstruction, hematemesis or severe facial trauma, thoracic or abdominal surgery in the previous 7 days.
- •A do-not-intubate order at time of inclusion.
研究组 & 干预措施
Continuous Positive Airway Pressure
Patients will receive continuous positive airway pressure
干预措施: Continuous Positive Airway Pressure (Device)
High-flow nasal oxygen
Patients will receive high-flow nasal oxygen
干预措施: High-flow nasal oxygen (Device)
Non-invasive ventilation
Patients will receive non-invasive ventilation
干预措施: Non-invasive ventilation (Device)
结局指标
主要结局
Intubation-free survival rate
时间窗: From randomization to 28 days
The proportion of patients who intubation-free and alive within 28 days after randomization.
次要结局
- Meeting the prespecified criteria for intubation within 28 days.(From randomization to 28 days)
- ICU mortality(From randomization to ICU discharge, assessed up to 60 days)
- In-hospital mortality(From randomization to hospital discharge, assessed up to 60 days)
- 28-day mortality(From randomization to 28 days)
- Intubation rate within 28 days(From randomization to 28 days)
- A ranked composite score incorporating death and intubation through day 28(From randomization to 28 days)
- Change in Discomfort scale after 1 hour of randomization(Time from randomization to 1hour)
- Invasive ventilator-free days at 28 days(From randomization to 28 days)
- Circulatory support-free days at day 28(From randomization to 28 days)
- Time from randomization to an improvement of two points on a seven-category ordinal scale(From randomization to 28 days)
- ICU-free days at day 28(From randomization to 28 days)
- Hospital-free days at day 28(From randomization to 28 days)
研究者
Ling Liu
Director of Intensive Care Unit, Principal Investigator, Clinical Professor
Southeast University, China