Skip to main content
OpenTrials
Completed

NCT Number: NCT03087825

Preoxygenation Method With a Calibrated Leak

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Preoxygenation Non Invasive Ventilation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Caen

Caen, 14033, France

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy volunteers

Exclusion criteria

  • any pathological condition
  • active tobaco

Treatment and study plan

preoxygenation without inward leak

Procedure

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

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

Primary outcomes

  1. end expiratory fraction of oxygen

    Time frame: 10 minutes

    end expiratory fraction of oxygen measured in exhaled gas

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 23, 2017
Registry last updated
Jul 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.