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Completed

NCT Number: NCT07334041

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.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Orléans

Orléans, 45067, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male or female
  • Healthy volunteer who has provided written informed consent
  • Age > 18 years

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Preoxygenation with VNI + OHD

Other

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 VNI

Other

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)

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in end-tidal oxygen fraction (FeO2) during each preoxygenation technique

    Time frame: 3 minutes

    Change in end-tidal oxygen fraction (FeO₂) will be evaluated by recording FeO₂ every 12 seconds during the 3-minute preoxygenation period.

  2. Maximum FeO2 value

    Time frame: 3 minutes

    Maximum FeO2 value achieved during the 3 minutes of each preoxygenation technique

  3. Average Oxygen Reserve Index (ORI) value

    Time frame: 3 minutes

    The ORI will be recorded every 30 seconds during preoxygenation. The mean ORI value at 3 minutes will be used for comparison.

  4. Maximum ORI value

    Time frame: 3 minutes

    Maximum ORI value achieved during the 3 minutes of each preoxygenation technique

  5. Change in ORI during each preoxygenation technique

    Time frame: 3 minutes

    Change in ORI will be evaluated by recording ORI every 2 seconds during the 3 minutes of preoxygenation.

  6. 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

  7. Time (in seconds) for ORI to return to 0 after cessation of preoxygenation.

    Time frame: 3 minutes

  8. Change in peripheral oxygen saturation (SpO2) during each preoxygenation technique

    Time frame: 3 minutes

    The change in SpO2 will be evaluated by recording SpO2 every 12 seconds during the 3 minutes of preoxygenation.

  9. Change in ventilator parameters (inspiratory and expiratory tidal volumes)

    Time frame: 3 minutes

    Change in inspiratory and expiratory tidal volumes measured every 30 seconds during the 3 minutes of preoxygenation.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional d'Orléans

Other

Registry information

Official study title

Comparison of Preoxygenation Techniques in Healthy Volunteers With Monitoring of End-tidal Oxygen Fraction (FeO₂) and Oxygen Reserve Index (ORI).

Acronym: OXYGAME1

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 12, 2026
Registry last updated
May 14, 2026

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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