UMOX™: A New Device for Preoxygenation

NCT01841255 | Completed DMC

• 1 other identifier: 06108
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Preoxygenation; Device; Tolerability; Efficacy

Outcome Measures

Primary Outcomes (1)

• The primary outcome measurement was the evolution of endtidal oxygen fraction during a 5 minute preoxygenation procedure, measurements were done continuously, maximum values were recorded

  The goal of this study is to compare the efficacy of preoxygenation using the conventional mask with the mouthpiece of the UMOX™ oropharyngeal device. The primary outcome measurement was endtidal oxygen fraction. The investigators also evaluated the respective tolerability of the two preoxygenation instruments in healthy volunteers. The measures were not part of a surgical procedure, participants were volunteers participating in this experimental design. No follow-up step was included in this protocol.

  The four steps were done sequentially, each step consisted of a 5 minute recording period under specific conditions, followed by a 10 minute pause before the next step

Secondary Outcomes (1)

• The investigators also evaluated the respective tolerability of the two preoxygenation instruments in healthy volunteers with a short questionnaire

  The four steps were done sequentially, each step consisted of a 5 minute recording period under specific conditions, followed by a 10 minute pause before the next step

Study Arms (4)

Tidal breathing using the facemask

SHAM COMPARATOR

Control

Device: facemask

Tidal volume breathing with the UMOXTM, device, no instruction

EXPERIMENTAL

First experimental measure

Device: Mouthpiece (Umox)

Tidal volume breathing with the UMOXTM device, instructions

EXPERIMENTAL

Second experimental measure

Device: Mouthpiece (Umox)

Tidal volume breathing with the UMOXTM, device, nose clip

EXPERIMENTAL

Third experimental measure

Device: Mouthpiece (Umox)

Interventions

Mouthpiece (Umox) DEVICE

Device used to perform preoxygenation in the operating room context

Also known as: Umox

Tidal volume breathing with the UMOXTM device, instructions; Tidal volume breathing with the UMOXTM, device, no instruction; Tidal volume breathing with the UMOXTM, device, nose clip

facemask DEVICE

Tidal breathing using the facemask

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both genders
• smokers and non-smokers
• American Society of Anesthesiologists (ASA) physical status I or II
• to 65 years old.

You may not qualify if:

• Presence of any craniofacial abnormality
• facial hair (beard or moustache) or absence of teeth.

Sponsors & Collaborators

• Maisonneuve-Rosemont Hospital: lead

Study Sites (1)

Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T 2M4, Canada

Location

Study Officials

• Louis P Fortier, MD, MSc

  Université de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Staff, Anesthesiology Dep.

Study Record Dates

• First Submitted: February 27, 2013
• First Posted: April 26, 2013
• Study Start: September 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: April 26, 2013

Record last verified: 2013-01

Locations

CA (1)