Inspiratory Support Improves Preoxygenation in Healthy Subjects

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: AI-6/PEEP-4; Other: AI-4/PEEP-4; Other: VS

• Registration Number: NCT00922753
• Lead Sponsor: Maisonneuve-Rosemont Hospital

Brief Summary

Preoxygenation optimizes oxygen content in the functional residual capacity (FRC). Adequate preoxygenation is defined by an expiratory oxygen fraction (FEO2) \> 90%. Inspiratory support and positive end expiratory pressure (PEEP) can create a better reservoir, improve gas exchange and shorten the time needed for adequate preoxygenation. The goal of the study is to evaluate the efficacy and tolerability of different levels of inspiratory support and positive end expiratory pressure during preoxygenation in healthy subjects.

Detailed Description

We conducted a double blind prospective randomized trial on 20 healthy volunteers. Each subject went through three modes of preoxygenation in random order: normal breathing (SP), breathing under inspiratory support 4 cmH2O/PEEP 4 cmH2O (PSM-4) and inspiratory support 6 cmH2O /PEEP 4 cmH2O (PSM-6). Each mode lasted for 3 min and parameters were recorded every 10 s. We evaluated subject's tolerance, leaks and easiness of each mode of preoxygenation according to a simplified (1 to 4) scale. Two-way ANOVA was used to compare FEO2 while simple ANOVA was used for time to reach FEO2=90%.

Study Timeline

• Study Start: 2007-02
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Status Verified: 2009-06
• Study First Submitted: 2009-06-16
• Study First Submitted QC: 2009-06-16
• Study First Posted: 2009-06-17
• Last Update Submitted: 2009-06-17
• Last Update Posted: 2009-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Healthy volunteers
• Aged between 20 to 40 years

Exclusion Criteria

• Body mass index > 30
• Mustache, beard
• Claustrophobia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BiPAP6 assisted preoxygenation	AI-6/PEEP-4	-
BiPAP4 assisted preoxygenation	AI-4/PEEP-4	-
Standard preoxygenation (VS)	VS	-

Primary Outcome Measures

Name	Time	Method
expiratory oxygen fraction (end-tidal 02)

Secondary Outcome Measures

Name	Time	Method
inspiratory oxygen fraction
end-tidal CO2
tidal volume
inspiratory pressure
subject's tolerance
leaks around the mask during preoxygenation
minute volume
endexpiratory pressure

Trial Locations

Locations (1)

Maisonneuve Rosemont Hospital; 🇨🇦 Montreal, Quebec, Canada