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During preoxygenation, imperfect seal between the face mask and patient's face can induce an inward air leak decreasing its effectiveness. We assume that noninvasive ventilation could cancel the effect of the leak.
This is a prospective study. Healthy volunteers are randomised in cross-over between spontaneous breathing or noninvasive ventilation pressure support preoxygenation in the presence or absence of a calibrated leak on the inspiratory circuit.
During preoxygenation, imperfect seal between the face mask and patient's face can induce an inward air leak decreasing its effectiveness. We assume that noninvasive ventilation could cancel the effect of the leak.
We planned an experimental study with healthy volunteers (residents in anesthesiology).
Healthy volunteers are randomised in cross-over between preoxygenation through spontaeous breathing or noninvasive ventilation pressure support preoxygenation in the presence or absence of a calibrated leak on the inspiratory circuit. The inspiratory fraction of oxygen is 100%. The exhaled gas (oxygen and carbon dioxide) are monitored.The subjects breathed through a mouthpiece (with a nose clip) connected to an anesthetic ventilator.
The primary endpoint is the time to achieve end expiratory fraction of oxygene of 90% or more.
The secondary endpoint is the proportion of subject with end expiratory fraction of oxygen of 90% or more after a 3 min period (recommended in clinical guidelines).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| spontaneous breathing | Sham Comparator | preoxygenation through spontaneous breathing of 100% oxygen gas flow with or without an inward air leak |
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| pressure support ventilation | Active Comparator | preoxygenation through non invasive pressure support ventilation of 100% oxygen gas flow (inspiratory trigger sensitivity set at -2 l.min-1, the positive inspiratory support set at +6 cmH2O, the PEEP set at +5 cmH2O and the maximal airway pressure was limited at 15 cmH2O.) with or without an inward air leak |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| preoxygenation without inward leak | Procedure | breathing a 100% inspired oxygen gas flow during 3 to 10 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| end expiratory fraction of oxygen | end expiratory fraction of oxygen measured in exhaled gas | 10 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| jean-luc hanouz, m.D,ph.d | CHU de Caen and universite Caen Normandie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Caen | Caen | 14033 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29576128 | Derived | Hanouz JL, Le Gall F, Gerard JL, Terzi N, Normand H. Non-invasive positive-pressure ventilation with positive end-expiratory pressure counteracts inward air leaks during preoxygenation: a randomised crossover controlled study in healthy volunteers. Br J Anaesth. 2018 Apr;120(4):868-873. doi: 10.1016/j.bja.2017.12.002. Epub 2018 Jan 17. |
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2 groups : spontaneous breathing and non invasive pressure support ventilation 2 conditions : without inward air leak and with inward air leak
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| preoxygenation with inward leak | Procedure | breathing a 100% inspired oxygen gas flow during 3 to 10 minutes with an inward air leak made possible through a specific calibrated piece on the inspiratory branch |
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