A Comparison of CPAP Delivered by Helmet and O2 Therapy With Venturi Mask for the Treatment of Acute Respiratory Failure in Community-acquired Pneumonia
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Time to Reach an Improvement in Terms of Gas Exchange, Defined as a PaO2/FiO2 Ratio ≥315
研究概览
简要总结
The purpose of this study is to compare the efficacy of CPAP application by a helmet and O2 administration by a Venturi mask in terms of gas exchanges improvement in patients with acute respiratory failure due to community-acquired pneumonia.
详细描述
Community-acquired pneumonia (CAP) is one of the commonest causes of hospitalised acute respiratory failure with a mortality rate up t 30%.
Continuous Positive Airway Pressure (CPAP) has ben recently proved to be effective. To date, however, no prospective randomised study has been published on the comparison between CPAP and O2 administration via a Venturi mask for the treatment of acute respiratory failure in immunocompetent patients with community-acquired pneumonia.
Therefore, the aim of this study is to compare the efficacy of CPAP delivered by a helmet and O2 administration via a Venturi mask in terms of gas exchanges improvement in early acute respiratory failure (PaO2/FiO2 between 210 and 285)due to community-acquired pneumonia.
A Steering Committee composed by the principal investigators will request an interim analysis at 20% enrolment in order to monitor the criteria for equipoise of the two treatments.
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
- •Community-acquired pneumonia (CAP) defined as: new chest x-ray pulmonary infiltrate, fever, and respiratory symptoms
- •Acute Hypoxemic Respiratory failure
- •Respiratory Rate < 35 breaths/min
- •PaO2/FiO2 > 200 and < 300 while breathing oxygen for at least 15 minutes via a Venturi mask with FiO2 0.5
- •Exclusion criteria
- •Immunosuppression
- •acute cardiogenic pulmonary edema
- •Patients belonging to Class II-III-IV of the NYHA
- •Acute coronary syndrome
- •Acute Respiratory Acidosis pH < 7.35 and PaCO2 > 45 mmHg
- •More than 3 acute organ failures
- •Systolic Pressure < 90 mmHg under fluid resuscitation or vasopressor drug use
- •Decreased level of consciousness (GCS <12)
- •Inability to clear secretions
- •Pre-defined intubation criteria
排除标准
- 未提供
结局指标
主要结局
Time to Reach an Improvement in Terms of Gas Exchange, Defined as a PaO2/FiO2 Ratio ≥315
时间窗: on admission and at 1, 6, 12, 24 and 48 hours until PaO2/FiO2 ratio ≥315
次要结局
- PaO2/FiO2 Ratio Mantainance(1, 6, 12, 24 and 48 hours)