Hypercapnic Acute Respiratory Failure: Is the Helmet an Effective Interface?"
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Arterial Blood gases
研究概览
简要总结
Lack of tolerance to the treatment, makes the interface choice for non-invasive ventilation (NIV) one of the key factor. To date the helmet is rarely used in Acute Hypercapnic Respiratory Failure (AHRF), because of its large dead space, despite in hypoxic respiratory failure, it is largely employed as a "rotating" strategy when the facial mask is poorly tolerated.
In a multicenter randomized controlled trial, the investigators will compare the clinical efficacy of a new helmet designed to specifically improve the performance in chronic obstructive pulmonary disease (COPD) versus a full face mask during an episode of AHRF.
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
- •pH < 7,35 and PaCO2 > 45 mmHg
- •respiratory rate > 20 b/min
排除标准
- •hypoxic respiratory failure
- •inability to stand NIV
- •lack of informed consent
结局指标
主要结局
Arterial Blood gases
时间窗: at 1 hour after the start of NIV
次要结局
- Arterial Blood Gases(Once a day at 8 am until discharge)
研究者
dr. Stefano Nava
Chief Respiratory and Critical care
IRCCS Azienda Ospedaliero-Universitaria di Bologna
