Non Invasive Mechanical Ventilation in Acute Cardiogenic Pulmonary Edema
关键词
抽象
描述
To evaluate the effect of adding continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP) to standard medical therapy (ST) on intensive care unit (ICU) stay, hospital stay, mortality, need for endotracheal intubation, partial arterial O2 tension (PaO2), intrapulmonary shunt, alveolar-arterial (A-a) oxygen gradient, and cardiac output in patients admitted to the respiratory intensive care unit (ICU) or cardiac care unit (CCU) with acute CPE with gas exchange abnormalities and to evaluate the impact of heart failure type on the outcome of different therapeutic schedules.
日期
| 最后验证: | 07/31/2009 |
| 首次提交: | 04/07/2009 |
| 提交的预估入学人数: | 04/08/2009 |
| 首次发布: | 06/02/2009 |
| 上次提交的更新: | 08/16/2009 |
| 最近更新发布: | 09/03/2009 |
| 首次提交结果的日期: | 04/07/2009 |
| 首次提交质量检查结果的日期: | 04/08/2009 |
| 首次发布结果的日期: | 06/02/2009 |
| 实际学习开始日期: | 09/30/2003 |
| 预计主要完成日期: | 10/31/2007 |
| 预计完成日期: | 10/31/2007 |
状况或疾病
干预/治疗
Other: ST
Device: CPAP + ST
Device: BiPAP + ST
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Active Comparator: CPAP + ST Continuous positive airway pressure (CPAP) and Standard medical therapy (ST) | Device: CPAP + ST Non-invasive mechanical ventilation (CPAP) |
| Active Comparator: BiPAP + ST Bilevel positive airway pressure (BiPAP) and standard medical therapy (ST) | Device: BiPAP + ST Non-invasive mechanical ventilation (BIPAP) |
| Active Comparator: ST Standard Medical therapy (ST) | Other: ST standard medical therapy |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: 1. CPE confirmed radiologically and/or clinically 2. Severe acute respiratory failure (partial arterial oxygen (PaO2)/Fraction of inspired oxygen (FIO2) less than 250) 3. Dyspnea of sudden onset with respiratory 4. Systolic blood pressure < 180 mmHg Exclusion Criteria: 1. Immediate need for endotracheal intubation: - Severe sensorial impairment - Shock - Ventricular arrhythmias, - Life-threatening hypoxia (SpO2 [oxygen saturation as indicated by pulse oximetry] less than 80% with oxygen) - Acute myocardial infarction necessitating thrombolysis - Cardiac or respiratory arrest 2. Severe chronic renal failure 3. Pneumothorax. 4. Contraindication of non invasive ventilation (NIV) |
结果
主要结果指标
1. Number of Patients Who Were Intubated [During ICU Stay]
次要成果指标
1. Arterial Blood Gases, Respiratory Rate, Blood Pressure, Cardiac Output ,Intrapulmonary Shunt, A-a Oxygen Gradient, Heart Rate, and Dyspnea Duration of Hospital and ICU Stay and Mortality [Hospital stay]
