Combination of High-flow Nasal Oxygen (Optiflow) and Vibrating Membrane Nebuliser (Aerogen) in the Pre-hospital Setting - Before/After Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Achievement of saturation targets
研究概览
简要总结
The aim of this observational before/after study is to determine how to optimally administer oxygen to patients experiencing an asthma or COPD exacerbation in emergency medical services.
The aim will be to determine which method will achieve the target oxygen saturation objectives: > 95% in asthma exacerbations and between 88% and 92% (or > 92% in ambient air or with FiO2 21%) in COPD exacerbations.
The study will compare a group "before" receiving standard care with a nebulizer mask to a group "after" using a combination of a vibrating membrane nebulizer and high-flow nasal oxygen.
详细描述
The "after" group will systematically receive both devices: vibrating membrane nebulizer and high-flow nasal oxygen.
In both groups, the choice of nebulized therapies will be left to the clinician's discretion.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •≥ 18 years of age
- •Exacerbation of asthma or COPD requiring nebulization
- •Free and informed consent
排除标准
- •Clinical signs of hypercapnia
- •Non French speaker
- •Contraindications to high-flow nasal oxygen: haemodynamic instability, Glasgow < 12, cardiorespiratory arrest, lack of airway protection, cardiogenic pulmonary oedema
- •Indication for orotracheal intubation
研究组 & 干预措施
Before
Treatment of exacerbation with nebulizer mask and oxygen therapy of 6 to 9 liters per minute
干预措施: nebulizer mask and oxygen therapy of 6 to 9 liters per minute (Device)
After
Treatment of the exacerbation by combining a vibrating membrane nebulizer and high-flow nasal oxygen, set with an FiO₂ between 21 and 100% and an O₂ flow rate between 30 and 70 liters per minute
干预措施: Vibrating membrane nebulizer and high-intensity nasal oxygen (Device)
结局指标
主要结局
Achievement of saturation targets
时间窗: at 15 minutes
* Asthma: SpO₂ at 15 min \> 95% * COPD: SpO₂ at 15 min 88-92% or SpO₂ \> 92% in ambient air or with FiO₂ 21%
次要结局
- FiO₂(at the end of care)
- flow rate(at the end of care)
- Likert scale(up to 30 minutes)
- Causes of failure(up to 30 minutes)