Clinical Efficacy of a Cephalic Mask for Noninvasive Ventilation During Acute Hypercapnic Respiratory Failure
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 试验地点
- 2
- 主要终点
- Arterial blood gases
研究概览
简要总结
Noninvasive ventilation (NIV) is now a major therapeutic option to manage patients with acute hypercapnic respiratory failure (AHRF). Otherwise, patient-ventilator interfaces are determinant to get an optimal NIV efficacy in parallel with ventilatory comfort.
Facial masks during NIV are associated with deleterious consequences like gas leaks around the mask, skin breakdown (especially on the nasal bridge), claustrophobia and mask discomfort. In order to limit these side effects, a cephalic interface has been recently designed. Cephalic mask covers the whole anterior surface of the face and excessive mask fit pressure is therefore spread over a larger surface outside the nose area. However, this mask has a high volume that may interfere with NIV efficacy and may also induce claustrophobic sensations.
The aim of this study is to compare the clinical efficacy and tolerance of a cephalic mask versus a conventional oronasal mask during 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
- •Acute hypercapnic respiratory failure
- •Indication to noninvasive ventilation
排除标准
- •Requirement for endotracheal intubation
- •Proven pulmonary embolism
- •Present or previous history of ophthalmologic disease
结局指标
主要结局
Arterial blood gases
次要结局
- Respiratory frequency
- Severity scores
- Ventilatory settings
- Patient-ventilator adaptation
- Tolerance
- Outcome
- Complications
