Comparing preoxygenation with non-invasive ventilation alone versus non-invasive ventilation plus high-flow nasal oxygen
Comparison of Preoxygenation Techniques in Healthy Volunteers With Monitoring of End-tidal Oxygen Fraction (FeO₂) and Oxygen Reserve Index (ORI).
We will test whether adding high-flow nasal oxygen to non-invasive ventilation improves oxygen reserves during three minutes of preoxygenation in healthy adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Régional d'Orléans Academic / other |
| Locations | 1 site (Orléans) |
| Trial ID | NCT07334041 on ClinicalTrials.gov |
What this trial studies
Healthy adult volunteers are assigned to receive three minutes of preoxygenation with either non-invasive ventilation (NIV) alone or NIV combined with high-flow nasal cannula (HFNC). Oxygenation is continuously monitored using end-tidal oxygen fraction (FeO2) and the Oxygen Reserve Index (ORI) throughout the preoxygenation period and subsequent simulated intubation phases. The protocol includes induction of anesthesia, a period of reduced spontaneous ventilation, an apnea/laryngoscopy phase, and initiation of mechanical ventilation after intubation. Key exclusions include chronic cardiac or pulmonary disease, BMI ≥ 30 kg/m², pregnancy, and lack of French social security affiliation.
Who should consider this trial
Good fit: Healthy adults aged over 18 who can give informed consent, without cardiac or pulmonary disease, with BMI under 30, and not pregnant are ideal candidates.
Not a fit: People with chronic lung or heart disease, those on long-term oxygen, individuals with BMI ≥ 30, pregnant or breastfeeding women, or those not eligible under the trial's exclusions are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the results could clarify whether combining HFNC with NIV improves oxygen reserves before intubation and inform safer preoxygenation practices.
How similar studies have performed: A prior single-center randomized trial (OPTINIV) reported benefit from combining NIV and HFNC for preoxygenation, but it remained unclear whether the effect was due to leak compensation or apneic oxygenation.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Orléans
- CHU Orléans — Orléans, France (Recruiting)
Study contacts
- Principal investigator: Mai-Anh NAH, MD — CHU d'Orléans
- Study coordinator: Mai-Anh NAH, MD
- Email: maianh.nay@chu-orleans.fr
- Phone: +33238575253
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.