Prehospital High-Flow Nasal Oxygen Therapy in Patients With Acute Hypoxemic Respiratory Failure: A Randomized, Open-label, Bi-center, Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- need of mechanical ventilation
研究概览
简要总结
The purpose of the present project is to compare High-Flow Nasal Oxygen therapy with Standard Oxygen therapy, initiated in the prehospital setting in patients with acute hypoxemia respiratory failure, in terms of oxygenation at arrival to the hospital and need of mechanical ventilation during the subsequent 28 days
详细描述
Patients with respiratory distress and an SpO2 below 90% in the prehospital setting will be randomized to receive either high-flow nasal oxygen therapy through a dedicated device or standard oxygen therapy through standard devices such as nasal cannula or face mask. Need of mechanical ventilation either invasive or noninvasive from enrollment to day 28 and time course of oxygenation between first SpO2 measured on scene and arrival to the hospital will be the main outcome measures.
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
- •First SpO2 on scene <90%
- •At least one other sign of respiratory distress defined by (a) respiratory distress with a respiratory rate ≥ 25/min; (b) laboured breathing
- •No advance directives or known decisions of Do Not intubate or Do Not Ventilate order.
排除标准
- •Known COPD or other hypercapnic chronic respiratory failure
- •age <18 years
- •Pregnancy or breastfeeding
- •Anatomical factors precluding the use of a nasal cannula
- •Emergency intubation required
- •Patients with tracheostomy
- •Patient transported to a hospital not involved in the study
研究组 & 干预措施
Standard oxygen therapy
Standard oxygen therapy will be delivered using any device or combination of devices that are part of usual care: nasal oxygen, and mask with or without a reservoir bag and with or without the Venturi system. The flow will be tapered to target an SpO2 ≥ 95%
干预措施: Standard oxygen therapy (Device)
High-flow nasal oxygen (HFNO)
Experimental: High-flow nasal oxygen (HFNO) group Device that delivers humidified and warmed high-flow oxygen at flows between 30-60L/min HFNO will be initiated at a flow rate between 30-60 L/min and FiO2 titrated for a target of SpO2 ≥ 95%.
干预措施: High-flow nasal oxygen (Device)
结局指标
主要结局
need of mechanical ventilation
时间窗: 28 days
cumulative incidence of the use of tracheal intubation or noninvasive ventilation (whichever comes first) from enrolment to day 28
次要结局
- arterial PaO2(1 hour)
- Hypoxemia(1 hour)
- Severe hypoxemia(1 hour)
- Survival(28 days)
- SpO2(1 hour)
- Respiratory rate(1 hour)
- Heart rate(1 hour)
- Tracheal intubation(28 days)
- Noninvasive ventilation(28 days)
- arterial pH(1 hour)
- arterial PaCO2(1 hour)
- Dyspnea(1 hour)
- Serious Adverse Events(Day 28)