Healthy Volunteers
Conditions
Keywords
healthy volunteers, HFNC, high flow oxygen, oximetry, capnometry, hypopharynx, standard oxygen therapy, oxygen face mask
Brief summary
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.
Detailed description
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.
Interventions
DEVICEHigh 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
Sponsors
I.M. Sechenov First Moscow State Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy Volunteers * Age 18-50 years * Written informed consent.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inspiratory oxygen fraction (FiO2) in the hypopharynx | 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 | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory rate (RR) | 5 minutes after the start of each combination of breathing pattern, device type, fraction of inspired oxygen and preset flow | Respiratory rate (RR) |
| Peripheral oxygen saturation (SpO2) | 5 minutes after the start of each combination of breathing pattern, device type, fraction of inspired oxygen and preset flow | Peripheral oxygen saturation (SpO2) during different physiological conditions |
| 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 | The ratio of oxygen saturation by pulse oximetry/inspiratory oxygen fraction to respiratory rate (ROX-index) during different physiological conditions |
| Comfort | 5 minutes after the start of each combination of breathing pattern, device type, fraction of inspired oxygen and preset flow | Visual-analog scale (VAS) for comfort evaluation (from 1 to 10, 1-full comfort, 10-full comfort) |
Countries
Russia
Contacts
PRINCIPAL_INVESTIGATORAndrey I Yaroshetskiy, MD, PhD, ScD
I.M. Sechenov First Moscow State Medical University
Outcome results
None listed