UMOX - New Device for Oropharyngeal Preoxygenation

This study has been completed.
Sponsor:
Information provided by:
Maisonneuve-Rosemont Hospital
ClinicalTrials.gov Identifier:
NCT01018316
First received: November 20, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  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 A previous study in our hospital (unpublished data) has shown that the UMOX was only as effective as the conventional mask when a nose clip was used to prevent the patients from breathing in some air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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01018316

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

No publications provided

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
Study First Received: November 20, 2009
Last Updated: November 20, 2009
Health Authority: Canada: Health Canada

Keywords provided by Maisonneuve-Rosemont Hospital:
preoxygenation
UMOX

ClinicalTrials.gov processed this record on April 23, 2014