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UMOX - New Device for Oropharyngeal Preoxygenation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01018316
First Posted: November 23, 2009
Last Update Posted: November 23, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Maisonneuve-Rosemont Hospital
November 20, 2009
November 23, 2009
November 23, 2009
September 2009
November 2009   (Final data collection date for primary outcome measure)
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No Changes Posted
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UMOX - New Device for Oropharyngeal Preoxygenation
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The UMOX is a device that has been designed as an alternative to the conventional face mask for preoxygenation to be used when an optimal preoxygenation with a facemask is difficult to achieve(i.e: when a leak is present. A previous study in our hospital (unpublished data) has shown that the UMOX was only as effective as the conventional mask when a nose clip was used to prevent the patients from breathing in some air through the nose, thus preventing the dilution/contamination of the 100% oxygen delivered.In that study, the verbal indication giving to the subjects to breathe through the mouth was better than no indication at all but still yielded unsatisfactory results.

For this reason, the present study was designed to verify the hypothesis that while using the UMOX for preoxygenation, the verbal indication of breathing 8 vital capacity breaths added to the indication of breathing through the mouth would bring equivalent results -measured by the expired fraction of oxygen- as a preoxygenation of normal tidal breathing through a facemask during 3 to 5 minutes.

Preoxygenation was performed with the 60 volunteers placed in the supine position with 100% oxygen. All volunteers went though preoxygenation with two techniques: 1) breathing normal tidal volumes at a normal respiratory rate for a period of 5 minutes through a tight fitting conventional face mask, and 2) eight deep breaths (i.e. vital capacity breaths) through the UMOX device with verbal indication to use only the mouth to breathe.

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Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
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Probability Sample
Healthy Volunteers
Preoxygenation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
November 2009
November 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • ASA I or II, smoker or non smoker

Exclusion Criteria:

  • patients under 18 years old or over 65 years old; edentulous patients or those with craniofacial malformations, beards or mustaches; patients that have >30 kg over their ideal weight; and patients with moderate to severe pulmonary pathology
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01018316
HMR-MEM
No
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Louis-Philippe Fortier, MSc, MD,FRCPC, Maisonneuve-Rosemont Hospital affiliated to the University of Montreal
Maisonneuve-Rosemont Hospital
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Maisonneuve-Rosemont Hospital
November 2009