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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
  Purpose

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 A previous study in our hospital (unpublished data) has shown that the UMOX was only as effective as the conventional mask when a nose clip was used to prevent the patients from breathing in some air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.


Condition
Preoxygenation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional

Further study details as provided by Maisonneuve-Rosemont Hospital:

Enrollment: 60
Study Start Date: September 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy Volunteers
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01018316


Locations
Canada, Quebec
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada, H1T 2M4
Sponsors and Collaborators
Maisonneuve-Rosemont Hospital
  More Information

Responsible Party: Louis-Philippe Fortier, MSc, MD,FRCPC, Maisonneuve-Rosemont Hospital affiliated to the University of Montreal
ClinicalTrials.gov Identifier: NCT01018316     History of Changes
Other Study ID Numbers: HMR-MEM
First Submitted: November 20, 2009
First Posted: November 23, 2009
Last Update Posted: November 23, 2009
Last Verified: November 2009

Keywords provided by Maisonneuve-Rosemont Hospital:
preoxygenation
UMOX