NCT07334041

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).

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Centre Hospitalier Régional d'Orléans · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

An intubation procedure is performed in several successive phases: 1. Preoxygenation phase: This phase consists of administering 100% oxygen for 3 to 5 minutes in order to increase oxygen reserves. 2. Alveolar hypoventilation phase: This phase begins with the administration of anesthetic agents, leading to a reduction in spontaneous ventilation. 3. Apnea phase: During this phase, laryngoscopy is performed and the endotracheal tube is inserted into the trachea. 4. 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

Interventions

Type	Name	Description
OTHER	Preoxygenation 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)
OTHER	Preoxygenation 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)

Timeline

• Start date: 2026-03-09
• Primary completion: 2027-02-01
• Completion: 2027-08-01
• First posted: 2026-01-12
• Last updated: 2026-03-30

Locations

1 site across 1 country: France