跳至主要内容
临床试验/NCT07019701
NCT07019701尚未招募不适用

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

I.M. Sechenov First Moscow State Medical University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年6月14日最近更新:
适应症
干预措施

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

Experimental

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验