High-Flow Nasal Therapy Versus Conventional Oxygen Therapy in Patients With COVID-19: A Randomized Controlled Trial (The COVID-HIGH Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 364
- 试验地点
- 27
- 主要终点
- Proportion of patients needing escalation of treatment during hospital stay
研究概览
简要总结
The aim of this unblinded parallel-group randomized multicenter clinical trial is to compare the clinical effectiveness of high flow nasal therapy (HFNT) with conventional oxygen therapy (COT) in patients with confirmed COVID-19 related acute hypoxemic respiratory failure.
详细描述
The interventions will be delivered in any hospital ward caring for COVID-19 patients.
The interventions under investigation will be high flow nasal therapy in comparison with conventional oxygen therapy.
HFNT will be delivered by any device (standalone machine or ventilators able to deliver it). The initial flow rate will be set at 40 L/min and potentially increased up to 60 L/min, according to patient tolerance. Large-bore nasal prongs will be selected according to the size of patients' nostrils (i.e. 2/3 of the diameter of the patient's nostril). A surgical mask will be placed on top of the HFNT interface. The temperature will be set at 37°C or 34 °C according to the patient's comfort. The FiO2 will be adjusted to maintain SpO2 between 92-96%. A feeding tube or a nasogastric tube will not represent a contraindication for the use of HFNT provided the patency of the used nostril.
Conventional Oxygen therapy will be delivered by any device or combination of devices used for delivering oxygen such as nasal cannula, Venturi Mask or Mask with or without a reservoir bag as per usual local practice. Oxygen flow will be titrated to achieve SpO2 between 92-96%.
Co-interventions: Patients potentially eligible for the study will be evaluated by the attending physicians and receive medical therapy based on the attending physician's decision and local protocols. Awake proning is allowed. Local protocols, including drugs and awake proning, will be discussed with the enrolling centers at the initiation visit, and adherence to WHO guidelines will be recommended. Written informed consent from all the patients will be collected.
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 old
- •Tested positive for SARS-CoV-2 using real-time reverse transcriptase PCR (RT-PCR) nasopharyngeal swabs
- •Clinical signs of acute respiratory infection and radiological evidence of pneumonia
- •Hospital admission in any ward or Emergency Department within 48 h
- •SpO2 ≤ 92% or PaO2/FiO2 < 300 in room air and need for oxygen therapy according to clinical judgment, at the screening.
排除标准
- •PaO2/FiO2 ≤ 200
- •Respiratory rate ≥ 28 breaths/min and or severe dyspnea and or use of accessory muscles
- •Need for immediate intubation or noninvasive ventilation (including CPAP) according to clinical judgment (e.g. clinical diagnosis of cardiogenic pulmonary edema, respiratory acidosis pH ≤ 7.3)
- •Patients already on CPAP/NIV or HFNT at study screening
- •Septic shock
- •Evidence of multiorgan failure
- •Glasgow Coma Scale < 13
- •Inability to comprehend the study content and give informed consent
- •PaCO2 > 45 mmHg, (if blood gas available) or history of chronic hypercapnia
- •Patient already on long-term oxygen therapy (LTOT) or home NIV/CPAP (even if only overnight)
- •Neuromuscular disease
- •Limitation of care based on patients' or physicians' decision
结局指标
主要结局
Proportion of patients needing escalation of treatment during hospital stay
时间窗: 28 days
Proportion of patients needing escalation of treatment (i.e. noninvasive ventilation - including CPAP - or intubation).
次要结局
- 60-day mortality(60 days from hospital admission)
- Proportion of patients needing intubation during hospital stay(28 days)
- 28-day mortality(28 days from hospital admission)
- Proportion of patients who receive NIV during hospital stay(28 days)
- Proportion of patients who terminate the study protocols for improvement(28 days)
- Length of stay in hospital(28 days)
- Ventilator-free days during hospital stay(28 days)
- Proportion of patients admitted to intensive care unit during hospital stay(28 days)
- Length of stay in ICU(28 day)
- Dyspnea score (BORG scale) during hospital stay(28 days)
- Days free from CPAP/NIV during hospital stay(28 days)
- ROX index during hospital stay(28 days)
- Proportion of patients who receive CPAP during hospital stay(28 days)
- Time to escalation of treatment to CPAP/NIV during hospital stay(28 days)
- Time to escalation of treatment to intubation/invasive ventilation during hospital stay(28 days)
- Oxygen-free days during hospital stay(28 days)
- Hospital mortality(28 days)
- National Early Warning Score 2 (NEWS2) during hospital stay(28 days)
- Treatment interruption due to intolerance during study treatment(28 days)
研究者
Andrea Cortegiani, MD
Principal Investigator
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo