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

NCT ID: NCT07334041

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-31
• Study Completion Date: 2027-08-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Non-invasive ventilation combined to high flow nasal cannula

\- 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%

Group Type: EXPERIMENTAL

Preoxygenation with VNI + OHD

Intervention Type: 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

\- 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

Group Type: EXPERIMENTAL

Preoxygenation with VNI

Intervention Type: 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)

Interventions

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)

Intervention Type: 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)

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Régional d'Orléans

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mai-Anh NAH, MD

Role: PRINCIPAL_INVESTIGATOR

CHU d'Orléans

Locations

CHU Orléans

Orléans, , France

Countries

France

Central Contacts

Mai-Anh NAH, MD

Role: CONTACT

maianh.nay@chu-orleans.fr

+33238575253

Facility Contacts

Mai-Anh NAY, MD

Role: primary

Other Identifiers

CHUO-2025-21

Identifier Type: -

Identifier Source: org_study_id