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NCT Number: NCT06189716

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

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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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sechenov University Clinic#4

Moscow, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High flow oxygen through nasal cannula

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.

Primary outcomes

  1. Inspiratory oxygen fraction (FiO2) in the hypopharynx

    Time frame: 5 minutes

    Inspiratory oxygen fraction (FiO2) in the hypopharynx during different physiological conditions

  2. Expiratory oxygen fraction (FeO2) in the hypopharynx

    Time frame: 5 minutes

    Expiratory oxygen fraction (FeO2) in the hypopharynx during different physiological conditions

  3. Inspiratory fraction of carbon dioxide (FiCO2) in the hypopharynx

    Time frame: 5 minutes

    Inspiratory fraction of carbon dioxide (FiCO2) in the hypopharynx during different physiological conditions

  4. Expiratory fraction of carbon dioxide (FeCO2) in the hypopharynx

    Time frame: 5 minutes

    Expiratory fraction of carbon dioxide (FeCO2) in the hypopharynx during different physiological conditions

Secondary outcomes

  1. Respiratory rate (RR)

    Time frame: 5 minutes

    Respiratory rate (RR) during different physiological conditions

  2. Tidal volume (VT)

    Time frame: 5 minutes

    Tidal volume (VT) during different physiological conditions

  3. Peripheral oxygen saturation (SpO2)

    Time frame: 5 minutes

    Peripheral oxygen saturation (SpO2) during different physiological conditions

  4. Modified ventilatory ratio (mVR)

    Time frame: 5 minutes

    Modified ventilatory ratio (mVR) during different physiological conditions. mVR = [RR * tidal volume* (PetCO2 (mmHg) - 4 mmHg)] / [predicted body weight (kg) * 100 * 37,5 mmHg]

  5. The ratio of oxygen saturation by pulse oximetry/inspiratory oxygen fraction to respiratory rate (ROX-index)

    Time frame: 5 minutes

    ROX-index (SpO2/FiO2/RR) during different physiological conditions

  6. Comfort

    Time frame: 5 minutes

    Visual-analog scale (VAS) for comfort evaluation (from 1 to 10, 1-full comfort, 10-full comfort)

Sponsors and collaborators

Lead sponsor

I.M. Sechenov First Moscow State Medical University

Other

Registry information

Official study title

Evaluation of Gas Composition in the Oropharynx During High-flow Oxygen Therapy Through Nasal Cannula in Healthy Volunteers: a Physiological Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 3, 2024
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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