Non-invasive Ventilation Versus High Flow Oxygen Through Nasal Cannula in Pneumonia Associated Acute Hypoxemic Respiratory Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- PaO2/FiO2 improvement
研究概览
简要总结
The purpose of the study is to compare the efficacy of alternating Non Invasive Ventilation NIV and High Flow Oxygen HFO compared to High Flow Oxygen HFO alone on gas exchanges and prognosis in pneumonia-associated acute hypoxemic respiratory failure
详细描述
Both Non Invasive Ventilation (NIV) and High Flow Oxygen through nasal cannula (HFO) are widely used in the setting of hypoxemic respiratory failure of heterogeneous etiology, with no definitive evidence for the superiority of one technique on the other. The purpose of this study is to determine whether alternating NIV and HFO brings any advantage on gas exchanges and prognosis compared to the use of HFO alone in the homogeneous setting of pneumonia-associated 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
- •Diagnosis of pneumonia based on at least two clinical/laboratory criteria and 1 radiologic criterion among the following:
- •Clinical criteria: fever, cough, purulent sputum, pulmonary examination positive for signs consistent with pneumonia
- •Laboratory criteria: leukocytosis (White blood cells >10000/mcL) or leukopenia (White blood cells < 4000/mcL), rise of the inflammatory markers
- •Radiologic criteria: consolidations at Chest X-ray or CT scan
- •Hypoxemic respiratory failure, based on all the following criteria
- •PaO2/FiO2 < 300 after at least 15 minutes conventional oxygen therapy with a FiO2 ≥ 50%
- •Respiratory Rate (RR) ≥ 25/min or need for use of accessory muscles
- •Informed consent to study participation
排除标准
- •Age < 18 years
- •Hypercapnic respiratory failure (pCO2 > 60 mmHg at presentation) such as in Chronic Obstructive Pulmonary Disease
- •Presence of another cause of hypoxemic respiratory failure - e.g. pulmonary embolism, acute respiratory distress syndrome (ARDS), pulmonary oedema
- •Hemodynamic instability with necessity for use of inotropes and/or vasopressors
- •Indication for endotracheal intubation (ETI): Glasgow Coma Scale (GCS) <8, agitation, device intolerance, respiratory arrest
- •Immunosuppression (chronic immunosuppressive therapy, clinical history positive for any immunodeficiency - congenital or acquired)
- •Do Not Resuscitate (DNR) and Do Not Intubate (DNI) indication
- •Tracheostomy
- •Nocturnal CPAP ventilation therapy
- •Any other condition which the clinician would considered an adjunctive risk for taking part in the study or that would not permit the participant to complete it
研究组 & 干预措施
HFO
Continuous high flow oxygen through nasal cannula for 45 hours; longer if the clinical need persists
干预措施: High Flow Oxygen nasal cannula (Device)
NIV/HFO
Alternating noninvasive ventilation (3 hours) and high flow oxygen through nasal cannula (3 hours) for 45 hours; longer if the clinical need persists
干预措施: High Flow Oxygen nasal cannula (Device)
NIV/HFO
Alternating noninvasive ventilation (3 hours) and high flow oxygen through nasal cannula (3 hours) for 45 hours; longer if the clinical need persists
干预措施: Noninvasive ventilation (Device)
结局指标
主要结局
PaO2/FiO2 improvement
时间窗: at baseline and at 21 hours
Efficacy of alternating NIV and HFO compared to HFO alone in the determination of an improvement of PaO2/FiO2 at 21 hours compared to baseline PaO2/FiO2
次要结局
- PaO2/FiO2 improvement(at baseline and at 30 days)
- Intensive Care admission(30 days)
- Sensation of device comfort and dyspnoea(Baseline, at 21 hours, 45 hours and 30 days after beginning treatment. Optional measures can be taken at 1, 3 and 9 hours)
- Time to downgrade to conventional oxygen therapy(30 days)
- In-hospital mortality(30 days)
- New hospital admission(30 days)
- PaO2/FiO2 improvement(at baseline and at 45 hours)