Gas Composition in the Hypopharynx During High-flow Oxygen Therapy Through Nasal Cannula or Face Mask, or During Standard Oxygen Therapy Through a Non-Rebreather Face Mask in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Inspiratory oxygen fraction (FiO2) in the hypopharynx
研究概览
简要总结
The COVID-19 pandemic has become a huge global problem, affecting all spheres of human life, resulting in enormous social, economic consequences and human tragedies. With very decent results of treatment of patients of average severity in the conditions of bed units, the results of treatment of the most severe category - patients of intensive care units who required tracheal intubation remain extremely unsatisfactory. According to different data, mortality in this category of patients reaches 80-90%. However, observational, randomized studies and their meta-analyses have shown high efficiency of high-flow oxygen therapy through nasal cannulas, reaching 50-60%. Some pilot bench studies (on manikins) have shown the advantages of high-flow oxygen therapy over standard oxygen therapy in reducing anatomical dead space and preserving a given inspiratory fraction of oxygen in the laryngeal pharynx of the manikin, but the actual state of the laryngeal pharyngeal gas composition was not studied. Some patients breathe through open mouth that decreases the efficacy oh high flow oxygen through nasal cannula. The aim of the study is to measure the inspiratory (FiO2) and expiratory (FeO2) oxygen fractions and the inspiratory and expiratory carbon dioxide fractions (FiCO2 and FeCO2, respectively) in the hypopharynx of healthy volunteers during high-flow oxygen therapy through nasal cannula and face mask, and during standard oxygen therapy through non-rebreather face mask under different physiological conditions.
详细描述
Randomized controlled trials showed reduction of tracheal intubation in high- flow oxygen therapy through nasal cannula 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. Some patients breathe through open mouth that decreases the efficacy oh high flow oxygen through nasal cannula.
The aim of the study is to measure the inspiratory (FiO2) and expiratory (FeO2) oxygen fractions and the inspiratory and expiratory carbon dioxide fractions (FiCO2 and FeCO2, respectively) in the hypopharynx of healthy volunteers during high-flow oxygen therapy through nasal cannula and face mask, and during standard oxygen therapy through non-rebreather face mask under 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
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Volunteers
- •Age 18-50 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.
研究组 & 干预措施
Oxygen therapy
High flow oxygen through nasal cannula and face mask and standard oxygen therapy through non-rebreather face mask, and measurement of oxygen and carbon dioxide fraction in the hypopharynx High flow oxygen through nasal cannula and face mask, and standard oxygen therapy through non-rebreather face mask, and measurement of oxygen and carbon dioxide fraction in the hypopharynx of healthy volunteers in different physiological conditions
干预措施: High flow oxygen through nasal cannula and face mask and standard oxygen therapy through non-rebreather face mask, and measurement of oxygen and carbon dioxide fraction in the hypopharynx (Device)
结局指标
主要结局
Inspiratory oxygen fraction (FiO2) in the hypopharynx
时间窗: 5 minutes after the start of each combination of breathing pattern, device type, fraction of inspired oxygen and preset flow
Inspiratory oxygen fraction (FiO2) in the hypopharynx during high flow oxygen therapy through nasal cannula and face mask, and standard oxygen therapy through non-rebreather face mask different physiological conditions
Expiratory oxygen fraction (FeO2) in the hypopharynx
时间窗: 5 minutes after the start of each combination of breathing pattern, device type, fraction of inspired oxygen and preset flow
Expiratory oxygen fraction (FeO2) in the hypopharynx during high flow oxygen therapy through nasal cannula and face mask, and standard oxygen therapy through non-rebreather face mask different physiological conditions
Expiratory fraction of carbon dioxide (FeCO2) in the hypopharynx
时间窗: 5 minutes after the start of each combination of breathing pattern, device type, fraction of inspired oxygen and preset flow
Expiratory fraction of carbon dioxide (FeCO2) in the hypopharynx during high flow oxygen therapy through nasal cannula and face mask, and standard oxygen therapy through non-rebreather face mask different physiological conditions
次要结局
- Respiratory rate (RR)(5 minutes after the start of each combination of breathing pattern, device type, fraction of inspired oxygen and preset flow)
- Peripheral oxygen saturation (SpO2)(5 minutes after the start of each combination of breathing pattern, device type, fraction of inspired oxygen and preset flow)
- The ratio of oxygen saturation by pulse oximetry/inspiratory oxygen fraction to respiratory rate (ROX-index)(5 minutes after the start of each combination of breathing pattern, device type, fraction of inspired oxygen and preset flow)
- Comfort(5 minutes after the start of each combination of breathing pattern, device type, fraction of inspired oxygen and preset flow)
