Preoxygenation Method With a Calibrated Leak

Not Applicable

Completed

• Conditions: Preoxygenation; Non Invasive Ventilation
• Interventions: Procedure: preoxygenation without inward leak; Procedure: preoxygenation with inward leak

• Registration Number: NCT03087825
• Lead Sponsor: University Hospital, Caen

Brief 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).

Study Timeline

• Study Start: 2017-01-01
• Status Verified: 2017-02
• Study First Submitted: 2017-03-17
• Study First Submitted QC: 2017-03-17
• Study First Posted: 2017-03-23
• Primary Completion: 2017-03-31
• Study Completion: 2017-03-31
• Last Update Submitted: 2017-07-05
• Last Update Posted: 2017-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• healthy volunteers

Exclusion Criteria

• any pathological condition
• active tobaco

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
pressure support ventilation	preoxygenation without inward leak	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
spontaneous breathing	preoxygenation without inward leak	preoxygenation through spontaneous breathing of 100% oxygen gas flow with or without an inward air leak
spontaneous breathing	preoxygenation with inward leak	preoxygenation through spontaneous breathing of 100% oxygen gas flow with or without an inward air leak
pressure support ventilation	preoxygenation with inward leak	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

Primary Outcome Measures

Name	Time	Method
end expiratory fraction of oxygen	10 minutes	end expiratory fraction of oxygen measured in exhaled gas

Trial Locations

Locations (1)

University Hospital of Caen; 🇫🇷 Caen, France