Continuous Positive Airway Pressure Versus Non-Invasive Positive Pressure Support Ventilation in Acute Cardiogenic Pulmonary Oedema: a Prospective Randomised Multicentre Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Intubation rate
研究概览
简要总结
To assess the intubation rate in patients affected by severe cardiogenic pulmonary edema treated with CPAP or NPPV.
详细描述
Background Although non-invasive ventilation has shown to be an effective treatment for acute cardiogenic pulmonary oedema (ACPO), literature still lacks of multi-centre randomised prospective studies that compares CPAP with NPPV.
Aim of the study was to assess efficacy and safety of CPAP and NPPV in patients with ACPO.
Methods 80 patients with ACPO were randomly assigned to receive CPAP or NPPV (40 for each group) through a face mask.
Inclusion criteria were: severe dyspnoea, respiratory rate > 30, PaO2/FiO2 < 200, muscle fatigue.
Main end-points were endotracheal intubation, length of ventilation, hospital length of stay and mortality.
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
- •rapid onset of the symptoms
- •severe dyspnoea at rest
- •respiratory rate > 30 breath per minute
- •use of accessory respiratory muscles
- •PaO2/FiO2 < 200, radiological findings of ACPE
排除标准
- •ST elevation myocardial infarction
- •hemodynamic instability (systolic arterial pressure < 90 mmHg
- •need for immediate endotracheal intubation (respiratory arrest, bradypnea
- •inability to protect the airways, impaired sensorium (agitation or unconsciousness
- •inability to clear secretions, respiratory tract infections
- •chronic obstructive pulmonary disease (COPD) exacerbation, chronic respiratory failure necessitating long-term oxygen therapy
- •pulmonary embolism, pneumonia, recent oesophageal-gastric surgery
- •gastrointestinal bleeding
- •facial deformities
- •haematological malignancy or cancer with Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2.
结局指标
主要结局
Intubation rate
次要结局
- time of recovery
- hospital length of stay
- mortality and improvement in gas exchange