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
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
March 17, 2017
CompletedFirst Posted
Study publicly available on registry
March 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2017
CompletedJuly 7, 2017
February 1, 2017
3 months
March 17, 2017
July 5, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
end expiratory fraction of oxygen
end expiratory fraction of oxygen measured in exhaled gas
10 minutes
Study Arms (2)
spontaneous breathing
SHAM COMPARATORpreoxygenation through spontaneous breathing of 100% oxygen gas flow with or without an inward air leak
pressure support ventilation
ACTIVE COMPARATORpreoxygenation 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
Interventions
breathing a 100% inspired oxygen gas flow during 3 to 10 minutes
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
Eligibility Criteria
You may qualify if:
- healthy volunteers
You may not qualify if:
- any pathological condition
- active tobaco
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital of Caen
Caen, 14033, France
Related Publications (1)
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.
PMID: 29576128DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
jean-luc hanouz, m.D,ph.d
CHU de Caen and universite Caen Normandie
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 17, 2017
First Posted
March 23, 2017
Study Start
January 1, 2017
Primary Completion
March 31, 2017
Study Completion
March 31, 2017
Last Updated
July 7, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share