RecruitingNot ApplicableNCT07334041

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

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


Sponsor

Centre Hospitalier Régional d'Orléans

Enrollment

30 participants

Start Date

Mar 9, 2026

Study Type

INTERVENTIONAL

Conditions

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 volunteers.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

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

Exclusion Criteria12

  • 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

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Interventions

OTHERPreoxygenation with VNI + OHD

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)

OTHERPreoxygenation with VNI

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)


Locations(1)

CHU Orléans

Orléans, France

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NCT07334041


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