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

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.

Study Overview

• Status: Completed
• Conditions: Preoxygenation; Non Invasive Ventilation
• Intervention / Treatment: Procedure: preoxygenation without inward leak; Procedure: preoxygenation with inward leak

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Caen, France, 14033
    • University hospital of Caen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• healthy volunteers

Exclusion Criteria:

• any pathological condition
• active tobaco

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: spontaneous breathing; preoxygenation through spontaneous breathing of 100% oxygen gas flow with or without an inward air leak	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
Active Comparator: 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
end expiratory fraction of oxygen	end expiratory fraction of oxygen measured in exhaled gas	10 minutes

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Investigators: Principal Investigator: jean-luc hanouz, m.D,ph.d, CHU de Caen and universite Caen Normandie

Publications and helpful links

General Publications

• Hanouz JL, Le Gall F, Gerard JL, Terzi N, Normand H. Non-invasive positive-pressure ventilation with positive end-expiratory pressure counteracts inward air leaks during preoxygenation: a randomised crossover controlled study in healthy volunteers. Br J Anaesth. 2018 Apr;120(4):868-873. doi: 10.1016/j.bja.2017.12.002. Epub 2018 Jan 17.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): March 31, 2017
• Study Completion (Actual): March 31, 2017

Study Registration Dates

• First Submitted: March 17, 2017
• First Submitted That Met QC Criteria: March 17, 2017
• First Posted (Actual): March 23, 2017

Study Record Updates

• Last Update Posted (Actual): July 7, 2017
• Last Update Submitted That Met QC Criteria: July 5, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: A15-D28-VOL.25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No