Healthy VolunteersO2-OXIMETRYNCT07019701
Gas Composition in the Hypopharynx During High-flow or Standard Oxygen Therapy Through Face Mask in Healthy Volunteers
A study testing 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 in people with Healthy Volunteers, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- 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
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteRussia
- Study dates
- 30 Jun 2025to 1 Nov 2025
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Volunteers
- Age 18-50 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.
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- 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
- Keywords
- healthy volunteers, HFNC, high flow oxygen, oximetry, capnometry, hypopharynx, standard oxygen therapy, oxygen face mask
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 hypopharynxDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inspiratory oxygen fraction (FiO2) in the hypopharynx
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
Measured: 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
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
Measured: 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
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
Measured: 5 minutes after the start of each combination of breathing pattern, device type, fraction of inspired oxygen and preset flow
Secondary outcomes (4)
Respiratory rate (RR)
Respiratory rate (RR)
Measured: 5 minutes after the start of each combination of breathing pattern, device type, fraction of inspired oxygen and preset flow
Peripheral oxygen saturation (SpO2)
Peripheral oxygen saturation (SpO2) during different physiological conditions
Measured: 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)
The ratio of oxygen saturation by pulse oximetry/inspiratory oxygen fraction to respiratory rate (ROX-index) during different physiological conditions
Measured: 5 minutes after the start of each combination of breathing pattern, device type, fraction of inspired oxygen and preset flow
Comfort
Visual-analog scale (VAS) for comfort evaluation (from 1 to 10, 1-full comfort, 10-full comfort)
Measured: 5 minutes after the start of each combination of breathing pattern, device type, fraction of inspired oxygen and preset flow
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start30 Jun 2025
- Primary completion30 Sep 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrey I Yaroshetskiy, MD, PhD, ScD, Principal investigator, I.M. Sechenov First Moscow State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07019701
- Sponsor's protocol ID
- HFNC2-OXIMETRY
- Acronym
- O2-OXIMETRY
- Status last verified
- May 2025
- First submitted
- 26 May 2025
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be shared upon reasonable request
Publications
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 35072713Ospina-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 34874419He 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 37165464Grieco 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 34232336Frat 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07019701
- Acronym / sponsor ID
- O2-OXIMETRY / HFNC2-OXIMETRY
- Conditions
- Healthy Volunteers
- Keywords
- healthy volunteers, HFNC, high flow oxygen, oximetry, capnometry, hypopharynx, standard oxygen therapy, oxygen face mask
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 13 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oxygen therapy | Experimental | Device: 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 hypopharynxHigh 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy Volunteers
- Age 18-50 years
- Written informed consent.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 hypopharynxHigh 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 | Device | Oxygen therapy |
Primary outcome
Inspiratory oxygen fraction (FiO2) in the hypopharynx
Time frame: 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
Time frame: 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
Time frame: 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
4 secondary outcomes
Respiratory rate (RR)
Time frame: 5 minutes after the start of each combination of breathing pattern, device type, fraction of inspired oxygen and preset flow
Peripheral oxygen saturation (SpO2)
Time frame: 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)
Time frame: 5 minutes after the start of each combination of breathing pattern, device type, fraction of inspired oxygen and preset flow
Comfort
Time frame: 5 minutes after the start of each combination of breathing pattern, device type, fraction of inspired oxygen and preset flow
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Background: PubMed 35072713Perkins 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.
- Background: PubMed 34874419Ospina-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.
- Background: PubMed 37165464He 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.
- Background: PubMed 34232336Grieco 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.
- Background: PubMed 25981908Frat 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.
- Individual participant dataSharing planned: Yes. All data will be shared upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrey I Yaroshetskiy, MD, PhD, ScD principal investigator
I.M. Sechenov First Moscow State Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 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 25 Mar 2026. 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 after the start of each combination of breathing pattern, device type, fraction of inspired oxygen and preset flow). The study lists 3 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 NCT07019701, which also lists 5 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 25 Mar 2026.