NCT06489379尚未招募不适用
High Flow Nasal Oxygen for Acute Hypoxemic Respiratory Failure in the Emergency Room: the GLAMOUR Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 234
- 主要终点
- Early deterioration
研究概览
简要总结
The aim of this multicenter, randomized, controlled, open-label trial is to investigate the efficacy of early treatment with HFNO compared with SOT in preventing early deterioration of patients admitted to the ER because of 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
- 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 years;
- •PaO2/FiO2 ratio between 250 and 150 mmHg or SpO2/FiO2 ratio between 190 and 274, after at least 15 minutes of spontaneous breathing through a Venturi mask (VM), with a FiO2 targeted at a SpO2 94-97%;
- •Respiratory rate(RR)≤35breaths/min,afteratleast15minutesofspontaneous breathing through a VM, with a FiO2 targeted at a SpO2 94-97%;
- •PaCO2 ≤ 45 mmHg;
- •Unilateral or bilateral infiltrate(s), as detected with chest radiography and/or computed tomography and/or with lung ultrasound not fully explained by effusions, atelectasis, or nodules/masses. Infiltrates at lung ultrasound are defined as presence of focal B-lines, consolidations (with irregular marginal contour, air bronchogram, air trapping sign) and irregularity of the pleural line.
排除标准
- •Respiratory failure due to:
- •Acute asthma or COPD exacerbation,
- •Cardiac failure or fluid overload as primary cause of respiratory failure;
- •Unstable angina or ongoing acute myocardial infarction;
- •Acute respiratory acidosis with pH < 7.35 and PaCO2 > 45 mmHg;
- •Hemodynamic instability and/or use of vasopressors/inotropes;
- •Altered mental status (Kelly >3), see Figure 1;(18)
- •Contraindications to NIV (high risk of aspiration pneumonia, impaired airways protection, head-facial trauma and/or burns, uncooperative patient, cranial/thoracic/abdominal open wounds);
- •Indications to urgent intubation performed according to the clinician in charge;
- •Body Mass Index > 35 kg/m2;
- •Pregnancy;
- •Patient's refusal to participate.
结局指标
主要结局
Early deterioration
时间窗: 24 hours
occurrence of any of the following from randomization: respiratory worsening; respiratory acidosis; severe respiratory distress; start of non-invasive ventilation; necessity of endotracheal intubation; development of shock; death.
次要结局
- Development of hypercapnia(2, 12 and 24 hours)
- level of dyspnea(24 hours)
- Worsening respiratory distress(2, 12 and 24 hours)
- rate of ICU admission(90 days)
- hospital length-of-stay(30 days)
- Worsening hypoxemia(2, 12 and 24 hours)
- duration of any type of ventilatory support(90 days)
- in-hospital mortality(90 days)
- ICU length-of-stay(90 days)
- patient comfort(24 hours)
- standard vs asymmetrical high-flow nasal cannula(24 hours)
- Development of respiratory acidosis(2, 12 and 24 hours)
- ICU mortality(90 days)
- development of complications(90 days)
- clinical setting after ED stabilization(24 hours)
研究者
FRANCESCHI FRANCESCO
Professor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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