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UMOX - New Device for Oropharyngeal Preoxygenation

Sponsor
Maisonneuve-Rosemont Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01018316
Collaborator
(none)
60
Enrollment
1
Location
2
Duration (Months)
29.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 A previous study in our hospital (unpublished data) has shown that the UMOX was only as effective as the conventional mask when a nose clip was used to prevent the patients from breathing in some air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

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    60 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Study Start Date :
    Sep 1, 2009
    Actual Primary Completion Date :
    Nov 1, 2009
    Actual Study Completion Date :
    Nov 1, 2009

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 65 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      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

      Locations

      Site City State Country Postal Code
      1 Maisonneuve-Rosemont Hospital Montreal Quebec Canada H1T 2M4

      Sponsors and Collaborators

      • Maisonneuve-Rosemont Hospital

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT01018316
      Other Study ID Numbers:
      • HMR-MEM
      First Posted:
      Nov 23, 2009
      Last Update Posted:
      Nov 23, 2009
      Last Verified:
      Nov 1, 2009
      Keywords provided by , ,
      preoxygenation
      UMOX

      Study Results

      No Results Posted as of Nov 23, 2009