Healthy
Conditions
Keywords
Preoxygenation, High flow nasal cannula, Non-invasive ventilation, Healthy volunteers, Noninvasive Ventilation
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.
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)
Sponsors
Centre Hospitalier Régional d'Orléans
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
Randomized interventional crossover study comparing two preoxygenation techniques in healthy volunteers.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in end-tidal oxygen fraction (FeO2) at the end of each preoxygenation technique | 3 minutes | FeO2 will be collected every 12 seconds during preoxygenation. The mean FeO2 value at 3 minutes will be used for comparison between techniques. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in end-tidal oxygen fraction (FeO2) during each preoxygenation technique | 3 minutes | Change in end-tidal oxygen fraction (FeO₂) will be evaluated by recording FeO₂ every 12 seconds during the 3-minute preoxygenation period. |
| Maximum FeO2 value | 3 minutes | Maximum FeO2 value achieved during the 3 minutes of each preoxygenation technique |
| Average Oxygen Reserve Index (ORI) value | 3 minutes | The ORI will be recorded every 30 seconds during preoxygenation. The mean ORI value at 3 minutes will be used for comparison. |
| Maximum ORI value | 3 minutes | Maximum ORI value achieved during the 3 minutes of each preoxygenation technique |
| Change in ORI during each preoxygenation technique | 3 minutes | Change in ORI will be evaluated by recording ORI every 2 seconds during the 3 minutes of preoxygenation. |
| Time (in seconds) required to reach an ORI value ≥ 0.60 and FeO2 ≥ 90% during the 3 minutes of each preoxygenation technique | 3 minutes | — |
| Time (in seconds) for ORI to return to 0 after cessation of preoxygenation. | 3 minutes | — |
| Change in peripheral oxygen saturation (SpO2) during each preoxygenation technique | 3 minutes | The change in SpO2 will be evaluated by recording SpO2 every 12 seconds during the 3 minutes of preoxygenation. |
| Change in ventilator parameters (inspiratory and expiratory tidal volumes) | 3 minutes | Change in inspiratory and expiratory tidal volumes measured every 30 seconds during the 3 minutes of preoxygenation. |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORMai-Anh NAH, MD
CHU d'Orléans
Outcome results
None listed