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临床试验/NCT00912158
NCT00912158已完成4 期

CPAP Versus BiPAP in Acute Cardiogenic Pulmonary Edema: Experience With 129 Patients

Assiut University2 个研究点 分布在 1 个国家目标入组 129 人开始时间: 2003年10月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
129
试验地点
2
主要终点
Number of Patients Who Were Intubated

研究概览

简要总结

Cardiogenic pulmonary edema (CPE) is a common medical emergency and noninvasive ventilation (NIV) in addition to conventional medical treatment might be beneficial for patients with CPE.

详细描述

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.

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

入选标准

  • CPE confirmed radiologically and/or clinically
  • Severe acute respiratory failure (partial arterial oxygen (PaO2)/Fraction of inspired oxygen (FIO2) less than 250)
  • Dyspnea of sudden onset with respiratory
  • Systolic blood pressure < 180 mmHg

排除标准

  • Immediate need for endotracheal intubation:
  • Severe sensorial impairment
  • 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
  • Severe chronic renal failure
  • Pneumothorax.
  • Contraindication of non invasive ventilation (NIV)

结局指标

主要结局

Number of Patients Who Were Intubated

时间窗: During ICU Stay

Number of patients who were subjected to endotracheal intubation and invasive mechanical ventilation

次要结局

  • 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)

研究者

申办方类型
Other

研究点 (2)

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