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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.
An intubation procedure is performed in several successive phases:
Several devices can be used to perform preoxygenation:
Current recommendations from critical care societies suggest the use of:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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% |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in end-tidal oxygen fraction (FeO2) during each preoxygenation technique | Change in end-tidal oxygen fraction (FeO₂) will be evaluated by recording FeO₂ every 12 seconds during the 3-minute preoxygenation period. | 3 minutes |
| Maximum FeO2 value |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mai-Anh NAH, MD | CHU d'Orléans | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Orléans | Orléans | 45067 | France |
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Randomized interventional crossover study comparing two preoxygenation techniques in healthy volunteers.
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|
| 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:
|
|
Maximum FeO2 value achieved during the 3 minutes of each preoxygenation technique
| 3 minutes |
| Average Oxygen Reserve Index (ORI) value | The ORI will be recorded every 30 seconds during preoxygenation. The mean ORI value at 3 minutes will be used for comparison. | 3 minutes |
| Maximum ORI value | Maximum ORI value achieved during the 3 minutes of each preoxygenation technique | 3 minutes |
| Change in ORI during each preoxygenation technique | Change in ORI will be evaluated by recording ORI every 2 seconds during the 3 minutes of preoxygenation. | 3 minutes |
| 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 | The change in SpO2 will be evaluated by recording SpO2 every 12 seconds during the 3 minutes of preoxygenation. | 3 minutes |
| Change in ventilator parameters (inspiratory and expiratory tidal volumes) | Change in inspiratory and expiratory tidal volumes measured every 30 seconds during the 3 minutes of preoxygenation. | 3 minutes |