Gas Composition in the Oropharynx During High-flow Oxygen Therapy Through Nasal Cannula in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-09

Study Completion Date

2024-06-10

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Measurement of the inspiratory (FiO2) and expiratory (FeO2) fractions of oxygen (FiСO2 and FeСO2, respectively), as well as the inspiratory and expiratory fractions of carbon dioxide (FiСO2 and FeСO2, respectively) in the hypopharynx of healthy volunteers during high-flow oxygen therapy through nasal cannulas in different physiological conditions

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Experimental

High flow oxygen through nasal cannula, oxygen and carbon dioxide measurement in the hypopharynx

Group Type EXPERIMENTAL

High flow oxygen through nasal cannula

Intervention Type DEVICE

High flow oxygen through nasal cannula and measurement of oxygen and carbon dioxide fraction in the hypopharynx of healthy volunteers in different physiological conditions.

Interventions

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High flow oxygen through nasal cannula

High flow oxygen through nasal cannula and measurement of oxygen and carbon dioxide fraction in the hypopharynx of healthy volunteers in different physiological conditions.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Healthy Volunteers
* Age over 18 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes