Evaluation of Prolonged Apnea Supported by High Frequency Non-invasive Ventilation.
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Duration of apnea
研究概览
简要总结
The purpose of the study is to assess the efficacy of high-frequency non-invasive ventilation on apnea duration, carbon dioxide clearance and oxygen delivery in healthy subjets and patients with lung disease.
详细描述
High frequency ventilation (HF-V) allows to ensure oxygen delivery and carbon dioxide clearance despite the absence of thoracic movement in anesthetized, invasively ventilated subjects. This same technique could be applied by a non-invasive interface (HF-NIV), allowing to obtain a prolonged apnea (absence of thoraco-abdominal respiratory movements) in awaken subjects. Such an application would be of interest for several clinical applications, e.g. lung imaging and radio-therapy treatment on lung cancer. The purpose of the study is to assess the effect of different HF-NIV setting on the apnea duration, carbon dioxide clearance and oxygen delivery in healthy subjets and patients with lung diseases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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
- 是
入选标准
- •healthy subjets : normal respiratory function and no known lung disease
- •lung disease patients : chronic obstructive pulmonary disease, Sarcoidosis, Cystic fibrosis
- •age >=18y
排除标准
- •increased pneumothorax risk under positive pressure ventilation
- •pregnancy
研究组 & 干预措施
Low - High frequence sequence
High-Frequency non-invasive ventilation (HF-NIV) with 2 different settings, sequence of respiratory rate 250/min and respiratory rate 500/min
干预措施: High-frequency non-invasive ventilation (Device)
High - Low frequence sequence
High-Frequency non-invasive ventilation (HF-NIV) with 2 different settings, sequence of respiratory rate 500/min and respiratory rate 250/min
干预措施: High-frequency non-invasive ventilation (Device)
结局指标
主要结局
Duration of apnea
时间窗: 1 study session (2 hours)
Duration of apnea according to the different settings of the HF-NIV, defined as absence of thoraco-abdominal respiratory movements
次要结局
- Lung volume(1 study session (2 hours))
- Transcutaneous carbon dioxide partial pressure(1 study session (2 hours))
- Oxygen saturation of arterial blood(1 study session (2 hours))
- Subjective tolerance(1 study session (2 hours))
研究者
Adam Ogna
MD
Centre Hospitalier Universitaire Vaudois