Non Invasive Positive Airway Pressure And Risk Of Myocardial Infarction In Acute Cardiogenic Pulmonary Edema: Continuous Positive Airway Pressure Vs Non Invasive Positive Pressure Ventilation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- The rate of Acute Myocardial Infarction
研究概览
简要总结
This randomized controlled trial is primarily aimed at assessing the rate of acute myocardial infarction with the two noninvasive ventilatory techniques, non-invasive intermittent positive pressure ventilation and non-invasive continuous positive airway pressure.
详细描述
Objective
To determine whether the application of non-invasive intermittent positive pressure ventilation (n-IPPV) increases the incidence of acute myocardial infarction (AMI) in patients with acute respiratory failure (ARF) secondary to acute cardiogenic pulmonary edema (ACPE), as opposed to non-invasive continuous positive airway pressure (n-CPAP).
Background Both n-CPAP or n-IPPV are used to treat ACPE complicated by ARF. Two previous studies, however, report an increased rate of AMI associated with the use of n-IPPV.
Methods: Fifty-two patients with severe ARF consequent to ACPE were randomized to receive n-CPAP (n=27) or n-IPPV (n=25), both associated with standard medical therapy. Cardiac markers, electrocardiogram and clinical-physiological parameters were monitored at study entry, after 30 and 60 minutes, and every 6 hours for the first two days.
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 breaths per minute
- •use of accessory respiratory muscles
- •oxygen saturation (SpO2) inferior to 90% with an inspiratory oxygen fraction of 60% via a Venturi mask
- •radiological findings of ACPE
排除标准
- •acute ischemic heart disease (myocardial infarction, chest pain, ST elevation)
- •hemodynamic instability (i.e. systolic blood pressure < 90 with dopamine or dobutamine infusion ≥ 5 mcgr/Kg/min) or life-threatening arrhythmias
- •need for immediate endotracheal intubation (respiratory arrest, bradypnea or gasping)
- •inability to protect the airways
- •impaired sensorium (i.e. unconsciousness or agitation)
- •inability to clear secretions
- •respiratory tract infection
- •recent oesophageal/gastric surgery
- •gastrointestinal bleeding
- •facial deformities
- •hematological malignancy or cancer with an Eastern Cooperative Oncology Group performance status ≥ 2
- •chronic respiratory failure necessitating long-term oxygen therapy
- •diagnosis of myocardial infarction, pulmonary embolism, pneumonia, exacerbation of chronic obstructive pulmonary disease, pneumothorax in the previous 3 months
- •denial or refusal of intubation
- •claustrophobia
- •inclusion in other research protocols
结局指标
主要结局
The rate of Acute Myocardial Infarction
次要结局
- Rate of endotracheal intubation
- Mortality
- Time of recovery (i.e. duration of ventilatory assistance)
- High Dependency Unit and hospital length of stay