NCT03087825

Preoxygenation Method With a Calibrated Leak

Effect of Preoxygenation With Spontaneous Breathing or Noninvasive Positive Pressure Ventilation With or Without a Calibrated Leak. An Experimental Study in Healthy Volunteers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University Hospital, Caen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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).

Conditions

• Preoxygenation
• Non Invasive Ventilation

Interventions

Type	Name	Description
PROCEDURE	preoxygenation without inward leak	breathing a 100% inspired oxygen gas flow during 3 to 10 minutes
PROCEDURE	preoxygenation with inward leak	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

Timeline

• Start date: 2017-01-01
• Primary completion: 2017-03-31
• Completion: 2017-03-31
• First posted: 2017-03-23
• Last updated: 2017-07-07

Locations

1 site across 1 country: France