HealthyOXYGAME1NCT07334041
Comparison of Preoxygenation Techniques in Healthy Volunteers With Monitoring of End-tidal Oxygen Fraction (FeO₂) and Oxygen Reserve Index (ORI)
A study testing Preoxygenation with VNI + OHD and Preoxygenation with VNI in people with Healthy, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
Trial summary
The objective of this physiological study is to compare two preoxygenation techniques (non-invasive ventilation combined with high-flow nasal oxygen versus non-invasive ventilation alone) by monitoring end-tidal oxygen fraction (FeO₂) and the Oxygen Reserve Index (ORI) during 3 minutes of preoxygenation in healthy… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Preoxygenation with VNI + OHD and Preoxygenation with VNI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 9 Mar 2026to 29 Apr 2026
- 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
- Male or female
- Healthy volunteer who has provided written informed consent
- Age > 18 years
Who cannot join
- Long-term oxygen therapy
- Cardiac or pulmonary disease (including asthma)
- Presence of Raynaud's syndrome
- Claustrophobia
- Body mass index (BMI) ≥ 30 kg/m²
- Presence of nail polish preventing accurate SpO₂ and ORI measurement
Show all 12Show fewer
- Under legal protection
- Incarcerated individuals
- Persons deprived of liberty
- Not affiliated to French social security
- Pregnant or breastfeeding women
- Individuals currently participating in a drug study and still within the exclusion period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Preoxygenation Techniques in Healthy Volunteers With Monitoring of End-tidal Oxygen Fraction (FeO₂) and Oxygen Reserve Index (ORI).
The objective of this physiological study is to compare two preoxygenation techniques (non-invasive ventilation combined with high-flow nasal oxygen versus non-invasive ventilation alone) by monitoring end-tidal oxygen fraction (FeO₂) and the Oxygen Reserve Index (ORI) during 3 minutes of preoxygenation in healthy volunteers.
Read the detailed description
An intubation procedure is performed in several successive phases:
- Preoxygenation phase: This phase consists of administering 100% oxygen for 3 to 5 minutes in order to increase oxygen reserves.
- Alveolar hypoventilation phase: This phase begins with the administration of anesthetic agents, leading to a reduction in spontaneous ventilation.
- Apnea phase: During this phase, laryngoscopy is performed and the endotracheal tube is inserted into the trachea.
- Initiation of invasive mechanical ventilation: Once intubation is successful, the patient is placed on assisted mechanical ventilation.
Several devices can be used to perform preoxygenation:
- Bag-valve mask (BVM)
- High-flow nasal cannula therapy (HFNC)
- Non-invasive ventilation (NIV):
Current recommendations from critical care societies suggest the use of:
- BVM or HFNC for non-hypoxemic patients
- NIV for hypoxemic patients A single-center randomized controlled study (OPTINIV) demonstrated the benefit of combining NIV and HFNC for preoxygenation. However, placing an NIV mask over HFNC nasal cannulae may result in mask leaks, leading to ambient air entrainment, as well as a potential risk of excessive airway pressure related to HFNC. In this study, HFNC cannulae in the control group were left in place but inactive. Consequently, it remains difficult to determine whether the observed efficacy of the NIV + HFNC combination was related to leak compensation by HFNC during preoxygenation, or to apneic oxygenation provided by HFNC between laryngoscopy and successful intubation.
- Conditions
- Healthy
- Being tested
- Preoxygenation with VNI + OHD, Preoxygenation with VNI
- Keywords
- Preoxygenation, High flow nasal cannula, Non-invasive ventilation, Healthy volunteers, Noninvasive Ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoxygenation with VNI + OHDOther
Each preoxygenation session will last 3 minutes with the participant positioned at a 30° head-up angle.
A washout period of 10 minutes will be applied between each preoxygenation session, and initiation of the second preoxygenation technique will require the Oxygen Reserve Index (ORI) to return to 0.
Monitoring will include:
- Oxygen Reserve Index (ORI)
- End-tidal oxygen fraction (FeO₂) measured at the NIV mask
- Peripheral oxygen saturation (SpO₂)
Preoxygenation with VNIOther
Each preoxygenation session will last 3 minutes with the participant positioned at a 30° head-up angle.
A washout period of 10 minutes will be applied between each preoxygenation session, and initiation of the second preoxygenation technique will require the Oxygen Reserve Index (ORI) to return to 0.
Monitoring will include:
- Oxygen Reserve Index (ORI)
- End-tidal oxygen fraction (FeO₂) measured at the NIV mask
- Peripheral oxygen saturation (SpO₂)
| Study group | Role | What they receive |
|---|---|---|
| Non-invasive ventilation combined to high flow nasal cannula | Experimental | - NIV + HFNC: Non-invasive ventilation in pressure-controlled mode with inspiratory pressure adjusted to achieve a tidal volume of 6-8 mL/kg (in practice, inspiratory pressure between 5 and 10 cmH₂O) and a PEEP of 5 cmH₂O, combined with high-flow nasal cannula oxygen at 60 L/min with an FiO₂ of 100% Receives: Other: Preoxygenation with VNI + OHD |
| Non invasive ventilation | Experimental | - NIV alone in pressure-controlled mode with inspiratory pressure adjusted to achieve a tidal volume of 6-8 mL/kg (in practice, inspiratory pressure between 5 and 10 cmH₂O) and a PEEP of 5 cmH₂O Receives: Other: Preoxygenation with VNI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in end-tidal oxygen fraction (FeO2) at the end of each preoxygenation technique
FeO2 will be collected every 12 seconds during preoxygenation. The mean FeO2 value at 3 minutes will be used for comparison between techniques.
Measured: 3 minutes
Secondary outcomes (9)
Change in end-tidal oxygen fraction (FeO2) during each preoxygenation technique
Change in end-tidal oxygen fraction (FeO₂) will be evaluated by recording FeO₂ every 12 seconds during the 3-minute preoxygenation period.
Measured: 3 minutes
Maximum FeO2 value
Maximum FeO2 value achieved during the 3 minutes of each preoxygenation technique
Measured: 3 minutes
Average Oxygen Reserve Index (ORI) value
The ORI will be recorded every 30 seconds during preoxygenation. The mean ORI value at 3 minutes will be used for comparison.
Measured: 3 minutes
Maximum ORI value
Maximum ORI value achieved during the 3 minutes of each preoxygenation technique
Measured: 3 minutes
Change in ORI during each preoxygenation technique
Change in ORI will be evaluated by recording ORI every 2 seconds during the 3 minutes of preoxygenation.
Measured: 3 minutes
Time (in seconds) required to reach an ORI value ≥ 0.60 and FeO2 ≥ 90% during the 3 minutes of each preoxygenation technique
Measured: 3 minutes
Time (in seconds) for ORI to return to 0 after cessation of preoxygenation.
Measured: 3 minutes
Change in peripheral oxygen saturation (SpO2) during each preoxygenation technique
The change in SpO2 will be evaluated by recording SpO2 every 12 seconds during the 3 minutes of preoxygenation.
Measured: 3 minutes
Change in ventilator parameters (inspiratory and expiratory tidal volumes)
Change in inspiratory and expiratory tidal volumes measured every 30 seconds during the 3 minutes of preoxygenation.
Measured: 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start9 Mar 2026
- Primary completion29 Apr 2026
- Study completion29 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized interventional crossover study comparing two preoxygenation techniques in healthy volunteers.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mai-Anh NAH, MD, Principal investigator, CHU d'Orléans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07334041
- Sponsor's protocol ID
- CHUO-2025-21
- Acronym
- OXYGAME1
- Status last verified
- May 2026
- First submitted
- 30 Dec 2025
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Preoxygenation Techniques in Healthy Volunteers With Monitoring of End-tidal Oxygen Fraction (FeO₂) and Oxygen Reserve Index (ORI).
- ClinicalTrials.gov ID
- NCT07334041
- Acronym / sponsor ID
- OXYGAME1 / CHUO-2025-21
- Conditions
- Healthy
- Keywords
- Preoxygenation, High flow nasal cannula, Non-invasive ventilation, Healthy volunteers, Noninvasive Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- 29 Apr 2026 (actual)
- Study completion
- 29 Apr 2026 (actual)
- First posted
- 12 Jan 2026 (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 objective of this physiological study is to compare two preoxygenation techniques (non-invasive ventilation combined with high-flow nasal oxygen versus non-invasive ventilation alone) by monitoring end-tidal oxygen fraction (FeO₂) and the Oxygen Reserve Index (ORI) during 3 minutes of preoxygenation in healthy volunteers.
Detailed description
An intubation procedure is performed in several successive phases:
- Preoxygenation phase: This phase consists of administering 100% oxygen for 3 to 5 minutes in order to increase oxygen reserves.
- Alveolar hypoventilation phase: This phase begins with the administration of anesthetic agents, leading to a reduction in spontaneous ventilation.
- Apnea phase: During this phase, laryngoscopy is performed and the endotracheal tube is inserted into the trachea.
- Initiation of invasive mechanical ventilation: Once intubation is successful, the patient is placed on assisted mechanical ventilation.
Several devices can be used to perform preoxygenation:
- Bag-valve mask (BVM)
- High-flow nasal cannula therapy (HFNC)
- Non-invasive ventilation (NIV):
Current recommendations from critical care societies suggest the use of:
- BVM or HFNC for non-hypoxemic patients
- NIV for hypoxemic patients A single-center randomized controlled study (OPTINIV) demonstrated the benefit of combining NIV and HFNC for preoxygenation. However, placing an NIV mask over HFNC nasal cannulae may result in mask leaks, leading to ambient air entrainment, as well as a potential risk of excessive airway pressure related to HFNC. In this study, HFNC cannulae in the control group were left in place but inactive. Consequently, it remains difficult to determine whether the observed efficacy of the NIV + HFNC combination was related to leak compensation by HFNC during preoxygenation, or to apneic oxygenation provided by HFNC between laryngoscopy and successful intubation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized interventional crossover study comparing two preoxygenation techniques in healthy volunteers.
| Arm | Type | Receives |
|---|---|---|
| Non-invasive ventilation combined to high flow nasal cannula | Experimental | Other: Preoxygenation with VNI + OHD- NIV + HFNC: Non-invasive ventilation in pressure-controlled mode with inspiratory pressure adjusted to achieve a tidal volume of 6-8 mL/kg (in practice, inspiratory pressure between 5 and 10 cmH₂O) and a PEEP of 5 cmH₂O, combined with high-flow nasal cannula oxygen at 60 L/min with an FiO₂ of 100% |
| Non invasive ventilation | Experimental | Other: Preoxygenation with VNI- NIV alone in pressure-controlled mode with inspiratory pressure adjusted to achieve a tidal volume of 6-8 mL/kg (in practice, inspiratory pressure between 5 and 10 cmH₂O) and a PEEP of 5 cmH₂O |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female
- Healthy volunteer who has provided written informed consent
- Age > 18 years
Key exclusion criteria (12 listed)
- Long-term oxygen therapy
- Cardiac or pulmonary disease (including asthma)
- Presence of Raynaud's syndrome
- Claustrophobia
- Body mass index (BMI) ≥ 30 kg/m²
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 |
|---|---|---|
| Preoxygenation with VNI + OHDEach preoxygenation session will last 3 minutes with the participant positioned at a 30° head-up angle. A washout period of 10 minutes will be applied between each preoxygenation session, and initiation of the second preoxygenation technique will require the Oxygen Reserve Index (ORI) to return to 0. Monitoring will include: * Oxygen Reserve Index (ORI) * End-tidal oxygen fraction (FeO₂) measured at the NIV mask * Peripheral oxygen saturation (SpO₂) | Other | Non-invasive ventilation combined to high flow nasal cannula |
| Preoxygenation with VNIEach preoxygenation session will last 3 minutes with the participant positioned at a 30° head-up angle. A washout period of 10 minutes will be applied between each preoxygenation session, and initiation of the second preoxygenation technique will require the Oxygen Reserve Index (ORI) to return to 0. Monitoring will include: * Oxygen Reserve Index (ORI) * End-tidal oxygen fraction (FeO₂) measured at the NIV mask * Peripheral oxygen saturation (SpO₂) | Other | Non invasive ventilation |
Primary outcome
Change in end-tidal oxygen fraction (FeO2) at the end of each preoxygenation technique
Time frame: 3 minutes
FeO2 will be collected every 12 seconds during preoxygenation. The mean FeO2 value at 3 minutes will be used for comparison between techniques.
9 secondary outcomes
Change in end-tidal oxygen fraction (FeO2) during each preoxygenation technique
Time frame: 3 minutes
Maximum FeO2 value
Time frame: 3 minutes
Average Oxygen Reserve Index (ORI) value
Time frame: 3 minutes
Maximum ORI value
Time frame: 3 minutes
Change in ORI during each preoxygenation technique
Time frame: 3 minutes
Time (in seconds) required to reach an ORI value ≥ 0.60 and FeO2 ≥ 90% during the 3 minutes of each preoxygenation technique
Time frame: 3 minutes
Time (in seconds) for ORI to return to 0 after cessation of preoxygenation.
Time frame: 3 minutes
Change in peripheral oxygen saturation (SpO2) during each preoxygenation technique
Time frame: 3 minutes
Change in ventilator parameters (inspiratory and expiratory tidal volumes)
Time frame: 3 minutes
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 14 May 2026.
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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.
Mai-Anh NAH, MD principal investigator
CHU d'Orléans
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoxygenation with VNI + OHD and Preoxygenation with VNI in people with Healthy, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
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 12 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 14 May 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 France. 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?
Change in end-tidal oxygen fraction (FeO2) at the end of each preoxygenation technique (time frame: 3 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2026.