Preoxygenation Method With a Calibrated Leak

Caen University Hospital

Status: Completed

Conditions: Non Invasive Ventilation; Preoxygenation

Treatments: Procedure: preoxygenation without inward leak; Procedure: preoxygenation with inward leak

Study type: Interventional

Funder types: Other

Identifiers

NCT03087825

A15-D28-VOL.25

Details and patient eligibility

About

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.

Full 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).

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy volunteers

Exclusion criteria

• any pathological condition
• active tobaco

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

spontaneous breathing

Sham Comparator group

Description:

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

Treatment:

Procedure: preoxygenation without inward leak

Procedure: preoxygenation with inward leak

pressure support ventilation

Active Comparator group

Description:

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

Treatment:

Procedure: preoxygenation without inward leak

Procedure: preoxygenation with inward leak