Evaluation of Gas Composition in the Oropharynx During High-flow Oxygen Therapy Through Nasal Cannula in Healthy Volunteers: a Physiological Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Inspiratory oxygen fraction (FiO2) in the hypopharynx
研究概览
简要总结
Observational, randomized studies and their meta-analyses have shown the high effectiveness of high-flow oxygen therapy through nasal cannulas, reaching 50-60% in acute hypoxemic respiratory failure. Some bench studies showed the advantages of high-flow oxygen therapy compared with standard oxygen therapy, consisting in reducing the anatomical dead space and maintaining a given inspiratory oxygen fraction in the hypopharynx of the mannequin, but the actual state of the gas composition of the hypopharynx was not studied. The study aim is measurement of the inspiratory (FiO2) and expiratory (FeO2) fractions of oxygen, as well as the inspiratory (FiСO2) and expiratory (FeСO2) fractions of carbon dioxide in the hypopharynx of healthy volunteers during high-flow oxygen therapy through nasal cannulas in different physiological conditions.
详细描述
Randomized controlled trials showed reduction of tracheal intubation in high-flow oxygen therapy through nasal cannulas group in patients with acute respiratory failure as compared to standard oxygen therapy and noninvasive ventilation before Coronavirus disease-19 (COVID-19) pandemic.
The World Health Organization (WHO) declared the outbreak a pandemic of COVID-19 on March 11th, 2020. Since then observational, randomized studies and their meta-analyses have shown the high effectiveness of high-flow oxygen therapy through nasal cannulas (HFNC), reaching 50-60% in acute hypoxemic respiratory failure.
Bench studies showed the advantages of HFNC compared with standard oxygen therapy, consisting in reducing the anatomical dead space and maintaining a given inspiratory oxygen fraction in the hypopharynx of the mannequin, but the actual state of the gas composition of the hypopharynx during HFNC was not studied.
The study aim is measurement of the inspiratory (FiO2) and expiratory (FeO2) fractions of oxygen, as well as the inspiratory (FiСO2) and expiratory (FeСO2) fractions of carbon dioxide in the hypopharynx of healthy volunteers during high-flow oxygen therapy through nasal cannulas in different physiological conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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 Volunteers
- •Age over 18 years
- •Written informed consent.
排除标准
- •Any primary or secondary lung diseases (COPD, bronchial asthma, interstitial lung diseases, metastatic lung disease, lung cancer)
- •Any chronic diseases that can cause respiratory disorders (chronic heart failure, liver cirrhosis, systemic connective tissue diseases, cancer, neuromuscular diseases etc)
- •Heart rhythm disturbances
- •Body mass index more than 30 kg/m2
- •Swallowing disorders
- •History of epileptic syndrome
- •Recent head surgery or anatomy that precludes the use of nasal cannulas
- •Pregnancy and lactation period
- •Inability to cooperate with staff.
结局指标
主要结局
Inspiratory oxygen fraction (FiO2) in the hypopharynx
时间窗: 5 minutes
Inspiratory oxygen fraction (FiO2) in the hypopharynx during different physiological conditions
Inspiratory fraction of carbon dioxide (FiCO2) in the hypopharynx
时间窗: 5 minutes
Inspiratory fraction of carbon dioxide (FiCO2) in the hypopharynx during different physiological conditions
Expiratory oxygen fraction (FeO2) in the hypopharynx
时间窗: 5 minutes
Expiratory oxygen fraction (FeO2) in the hypopharynx during different physiological conditions
Expiratory fraction of carbon dioxide (FeCO2) in the hypopharynx
时间窗: 5 minutes
Expiratory fraction of carbon dioxide (FeCO2) in the hypopharynx during different physiological conditions
次要结局
- Respiratory rate (RR)(5 minutes)
- Tidal volume (VT)(5 minutes)
- The ratio of oxygen saturation by pulse oximetry/inspiratory oxygen fraction to respiratory rate (ROX-index)(5 minutes)
- Comfort(5 minutes)
- Peripheral oxygen saturation (SpO2)(5 minutes)
- Modified ventilatory ratio (mVR)(5 minutes)