NCT04468126已完成不适用
Impact on Mortality of an Oxygenation Strategy Including Standard Oxygen Versus High Flow Nasal Cannula Oxygen Therapy in Patients With Acute Hypoxemic Respiratory Failure: a Prospective, Randomized Controlled Trial.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,504
- 试验地点
- 2
- 主要终点
- Mortality at 28 days after randomization
研究概览
简要总结
First-line therapy of patients with acute respiratory failure consists in oxygen delivery through standard oxygen, high-flow nasal oxygen therapy through cannula or non-invasive ventilation. Non-invasive ventilation in acute hypoxemic respiratory failure is not recommended. In a large randomized controlled study, high-flow nasal oxygen has been described as superior to non-invasive ventilation and standard oxygen in terms of mortality but not of intubation. Paradoxically in immunocompromised patients, high-flow nasal oxygen has not been shown to be superior to standard oxygen. To improve the level of evidence of daily clinical practice, we propose comparing high-flow nasal oxygen versus standard oxygen, in terms of mortality in all patients with acute hypoxemic respiratory failure
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
- Single (Outcomes Assessor)
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
- •All consecutive patients older than 18 years with an acute hypoxemic respiratory failure will be enrolled if they meet all the following criteria:
- •Respiratory rate >25 breaths/min whatever the oxygen support
- •Pulmonary infiltrate,
- •PaO2/FiO2 ≤200 mmHg
- •Informed consent from the patient or relatives.
排除标准
- •PaCO2 > 45 mm Hg
- •Need for emergent intubation: pulse oximetry < 90% with maximum oxygen support, respiratory arrest, cardiac arrest, or Glasgow coma scale below 8 points
- •Hemodynamic instability defined by signs of hypoperfusion or use of vasopressors > 0.3 µg/kg/min
- •Glasgow coma scale equal to or below 12 points
- •Exacerbation of chronic lung disease including chronic obstructive pulmonary disease (grade 3 or 4 of Gold classification), or another chronic lung disease with long term oxygen or ventilatory support
- •Cardiogenic pulmonary edema as main reason for acute respiratory failure
- •Coronavirus SARS-2 infection as reason for acute respiratory failure (the SOHO-COVID study has been completed)
- •Post-extubation respiratory failure within 7 days after extubation,
- •Post-operative patients within 7 days after abdominal or cardiothoracic surgery,
- •Do not intubate order;
- •Already included in the study, refusal to participate or participation in another interventional study with the same primary outcome.
- •Patients without any healthcare insurance scheme or not benefiting from it through a third party,
- •Persons under law protection, namely minors, pregnant or breastfeeding women, persons deprived of their liberty by a judicial or administrative decision.
结局指标
主要结局
Mortality at 28 days after randomization
时间窗: Day 28
Death between randomization and 28 days after randomization
次要结局
- Failure of the oxygenation strategy between randomization and D28(Day 28)
- Complications during the ICU stay(Day 90)
- Comfort(Hour 6)
- Number of ventilation free days at Day 28(Day 28)
- Dyspnea(Hour 6)
- Duration between treatment initiation and intubation(Day 28)
- Level of oxygenation(Hour 48)
- Duration between the time when prespecified criteria of intubation are met and intubation(Day 28)
- Mortality in ICU, in hospital, and day 90(Day 90)
- Duration of ICU and hospital stay(Day 90)
- Organ Failure during the 48 hours after intubation.(Day 28)
研究者
研究点 (2)
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