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Healthy VolunteersNCT06189716

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

A study testing High flow oxygen through nasal cannula in people with Healthy Volunteers, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
High flow oxygen through nasal cannula
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteRussia
Study dates
9 Jan 2024to 10 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy Volunteers
  • Age over 18 years
  • Written informed consent.

Who cannot join

  • 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
Show all 9Show fewer
  • Recent head surgery or anatomy that precludes the use of nasal cannulas
  • Pregnancy and lactation period
  • Inability to cooperate with staff.

Trial locations and contacts

1 site in 1 country.

Russia1 site

  • Sechenov University Clinic#4

    Moscow, Moscow

Other trials in Russia

About this study

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

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.

Read the detailed description

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.

Being tested
High flow oxygen through nasal cannula
Keywords
healthy volunteers, HFNC, high flow oxygen, oximetry, capnometry, pharyngeal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High flow oxygen through nasal cannulaDevice

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

Study groups in NCT06189716
Study groupRoleWhat they receive
ExperimentalExperimentalHigh flow oxygen through nasal cannula, oxygen and carbon dioxide measurement in the hypopharynx
Receives: Device: High flow oxygen through nasal cannula

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Inspiratory oxygen fraction (FiO2) in the hypopharynx

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

    Measured: 5 minutes

  2. Expiratory oxygen fraction (FeO2) in the hypopharynx

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

    Measured: 5 minutes

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

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

    Measured: 5 minutes

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

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

    Measured: 5 minutes

Secondary outcomes (6)

  1. Respiratory rate (RR)

    Respiratory rate (RR) during different physiological conditions

    Measured: 5 minutes

  2. Tidal volume (VT)

    Tidal volume (VT) during different physiological conditions

    Measured: 5 minutes

  3. Peripheral oxygen saturation (SpO2)

    Peripheral oxygen saturation (SpO2) during different physiological conditions

    Measured: 5 minutes

  4. Modified ventilatory ratio (mVR)

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

    Measured: 5 minutes

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

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

    Measured: 5 minutes

  6. Comfort

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

    Measured: 5 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jan 2024
  2. Study start9 Jan 2024
  3. Primary completion30 Apr 2024
  4. Study completion10 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Model description
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
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06189716
Sponsor's protocol ID
HFNC-OXIMETRY
Status last verified
Dec 2023
First submitted
19 Dec 2023
Last updated
8 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Frat JP, Thille AW, Mercat A, Girault C, Ragot S, Perbet S, Prat G, Boulain T, Morawiec E, Cottereau A, Devaquet J, Nseir S, Razazi K, Mira JP, Argaud L, Chakarian JC, Ricard JD, Wittebole X, Chevalier S, Herbland A, Fartoukh M, Constantin JM, Tonnelier JM, Pierrot M, Mathonnet A, Beduneau G, Deletage-Metreau C, Richard JC, Brochard L, Robert R; FLORALI Study Group; REVA Network. High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. N Engl J Med. 2015 Jun 4;372(23):2185-96. doi: 10.1056/NEJMoa1503326. Epub 2015 May 17.

    PubMed 25981908

  • Grieco DL, Maggiore SM, Roca O, Spinelli E, Patel BK, Thille AW, Barbas CSV, de Acilu MG, Cutuli SL, Bongiovanni F, Amato M, Frat JP, Mauri T, Kress JP, Mancebo J, Antonelli M. Non-invasive ventilatory support and high-flow nasal oxygen as first-line treatment of acute hypoxemic respiratory failure and ARDS. Intensive Care Med. 2021 Aug;47(8):851-866. doi: 10.1007/s00134-021-06459-2. Epub 2021 Jul 7.

    PubMed 34232336

  • He Y, Zhuang X, Liu H, Ma W. Comparison of the efficacy and comfort of high-flow nasal cannula with different initial flow settings in patients with acute hypoxemic respiratory failure: a systematic review and network meta-analysis. J Intensive Care. 2023 May 10;11(1):18. doi: 10.1186/s40560-023-00667-2.

    PubMed 37165464

  • Ospina-Tascon GA, Calderon-Tapia LE, Garcia AF, Zarama V, Gomez-Alvarez F, Alvarez-Saa T, Pardo-Otalvaro S, Bautista-Rincon DF, Vargas MP, Aldana-Diaz JL, Marulanda A, Gutierrez A, Varon J, Gomez M, Ochoa ME, Escobar E, Umana M, Diez J, Tobon GJ, Albornoz LL, Celemin Florez CA, Ruiz GO, Caceres EL, Reyes LF, Damiani LP, Cavalcanti AB; HiFLo-Covid Investigators. Effect of High-Flow Oxygen Therapy vs Conventional Oxygen Therapy on Invasive Mechanical Ventilation and Clinical Recovery in Patients With Severe COVID-19: A Randomized Clinical Trial. JAMA. 2021 Dec 7;326(21):2161-2171. doi: 10.1001/jama.2021.20714.

    PubMed 34874419

  • Perkins GD, Ji C, Connolly BA, Couper K, Lall R, Baillie JK, Bradley JM, Dark P, Dave C, De Soyza A, Dennis AV, Devrell A, Fairbairn S, Ghani H, Gorman EA, Green CA, Hart N, Hee SW, Kimbley Z, Madathil S, McGowan N, Messer B, Naisbitt J, Norman C, Parekh D, Parkin EM, Patel J, Regan SE, Ross C, Rostron AJ, Saim M, Simonds AK, Skilton E, Stallard N, Steiner M, Vancheeswaran R, Yeung J, McAuley DF; RECOVERY-RS Collaborators. Effect of Noninvasive Respiratory Strategies on Intubation or Mortality Among Patients With Acute Hypoxemic Respiratory Failure and COVID-19: The RECOVERY-RS Randomized Clinical Trial. JAMA. 2022 Feb 8;327(6):546-558. doi: 10.1001/jama.2022.0028.

    PubMed 35072713

  • Yaroshetskiy AI, Krasnoshchekova AP, Tkachenko FD, Rubashchenko AV, Zubarev DD, Konanykhin VD, Savelenok MI, Nosenko MM, Merzhoeva ZM, Avdeev SN. Gas composition and pressure in the hypopharynx during high-flow oxygen therapy through a nasal cannula in healthy volunteers with different breathing patterns. BMC Anesthesiol. 2025 Aug 23;25(1):416. doi: 10.1186/s12871-025-03267-9.

    PubMed 40849448

Questions about this trial

What is this clinical trial studying?

A study testing High flow oxygen through nasal cannula in people with Healthy Volunteers, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Inspiratory oxygen fraction (FiO2) in the hypopharynx (time frame: 5 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06189716, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024; AzTrials last refreshed its copy on 6 Nov 2026.

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