MedTrace Logo

UMOX™: A New Device for Preoxygenation

NCT01841255 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2013-04-26

No results posted yet for this study

Summary

Background - Preoxygenation is performed before general anesthesia to increase the oxygen reserves of the body and prolong the safe period of apnea without hypoxia. However, it is often impossible to obtain a perfect face mask fit, and optimal end-tidal fractional oxygen concentration (EtO2) are not attained. The investigators designed a new oropharyngeal preoxygenation device, UMOX™, to avoid leaks during preoxygenation. In this study, the investigators compared the efficacy of UMOX™ with that of a conventional face mask.

Methods - In 50 healthy volunteers breathing 100% oxygen from a circle absorber system for a 5 minute-period, the investigators compared preoxygenation using the 1) a conventional mask; 2) UMOX™ without any instruction; 3) UMOX™ with instruction on mouth breathing; and 4) UMOX™ with a nose clip, in random order. Each subject underwent all steps with a 10-minute rest period of room air breathing between each step. Inspired and end-tidal respiratory gases were measured every 10 seconds. EtO2 variation was analyzed using Anova.

Conditions

  • Healthy

Interventions

DEVICE

Mouthpiece (Umox)

Device used to perform preoxygenation in the operating room context

DEVICE

facemask

Sponsors & Collaborators

  • Maisonneuve-Rosemont Hospital

    lead OTHER

Principal Investigators

  • Louis P Fortier, MD, MSc · Université de Montréal

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2008-11-30
Completion
2008-11-30

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01841255 on ClinicalTrials.gov