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

NCT07334041 | Completed

• 1 other identifier: CHUO-2025-21
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

Preoxygenation; High flow nasal cannula; Non-invasive ventilation; Healthy volunteers; Noninvasive Ventilation

Outcome Measures

Primary Outcomes (1)

• 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.

  3 minutes

Secondary Outcomes (9)

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

  3 minutes

• Maximum FeO2 value

  3 minutes

• Average Oxygen Reserve Index (ORI) value

  3 minutes

• Maximum ORI value

  3 minutes

• Change in ORI during each preoxygenation technique

  3 minutes

Study Arms (2)

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%

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

Other: Preoxygenation with VNI

Interventions

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)

Non-invasive ventilation combined to high flow nasal cannula

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)

Non invasive ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (1)

CHU Orléans

Orléans, 45067, France

Location

Study Officials

• Mai-Anh NAH, MD

  CHU d'Orléans

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized interventional crossover study comparing two preoxygenation techniques in healthy volunteers.

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: January 12, 2026
• Study Start: March 9, 2026
• Primary Completion: April 29, 2026
• Study Completion: April 29, 2026
• Last Updated: May 14, 2026

Record last verified: 2026-05

Locations

FR (1)