Preoxygenation Method With a Calibrated Leak

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2017-03-31

Brief Summary

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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.

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Detailed Description

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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.

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

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Preoxygenation Non Invasive Ventilation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

2 groups : spontaneous breathing and non invasive pressure support ventilation 2 conditions : without inward air leak and with inward air leak

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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spontaneous breathing

preoxygenation through spontaneous breathing of 100% oxygen gas flow with or without an inward air leak

Group Type SHAM_COMPARATOR

preoxygenation without inward leak

Intervention Type PROCEDURE

breathing a 100% inspired oxygen gas flow during 3 to 10 minutes

preoxygenation with inward leak

Intervention Type 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

pressure support ventilation

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

Group Type ACTIVE_COMPARATOR

preoxygenation without inward leak

Intervention Type PROCEDURE

breathing a 100% inspired oxygen gas flow during 3 to 10 minutes

preoxygenation with inward leak

Intervention Type 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

Interventions

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preoxygenation without inward leak

breathing a 100% inspired oxygen gas flow during 3 to 10 minutes

Intervention Type 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

Intervention Type PROCEDURE