Inspiratory Support Improves Preoxygenation in Healthy Subjects

Sponsor

Maisonneuve-Rosemont Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00922753

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: VS Other: AI-4/PEEP-4 Other: AI-6/PEEP-4	N/A

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

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 Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Official Title:

The Efficacy and Tolerability of Different Levels of Inspiratory Support and PEEP During Preoxygenation. A Randomized Controlled Trial.

Study Start Date :

Feb 1, 2007

Actual Primary Completion Date :

Sep 1, 2007

Actual Study Completion Date :

Sep 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: BiPAP6 assisted preoxygenation	Other: AI-6/PEEP-4 Spontaneous breathing of 100% oxygen in a facemask with application of an inspiratory pressure of 6 cm H2O and a positive end-expiratory pressure of 4 cm H2O, for 3 minutes.
Active Comparator: BiPAP4 assisted preoxygenation	Other: AI-4/PEEP-4 Spontaneous breathing of 100% oxygen in a facemask with application of an inspiratory pressure of 4 cm H2O and a positive end-expiratory pressure of 4 cm H2O, for 3 minutes
Active Comparator: Standard preoxygenation (VS)	Other: VS Spontaneous breathing of 100% oxygen in a facemask for 3 minutes

Arm

Intervention/Treatment

Active Comparator: BiPAP6 assisted preoxygenation

Other: AI-6/PEEP-4

Spontaneous breathing of 100% oxygen in a facemask with application of an inspiratory pressure of 6 cm H2O and a positive end-expiratory pressure of 4 cm H2O, for 3 minutes.

Active Comparator: BiPAP4 assisted preoxygenation

Other: AI-4/PEEP-4

Spontaneous breathing of 100% oxygen in a facemask with application of an inspiratory pressure of 4 cm H2O and a positive end-expiratory pressure of 4 cm H2O, for 3 minutes

Active Comparator: Standard preoxygenation (VS)

Other: VS

Spontaneous breathing of 100% oxygen in a facemask for 3 minutes

Outcome Measures

Primary Outcome Measures

expiratory oxygen fraction (end-tidal 02) []

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy volunteers
Aged between 20 to 40 years

Exclusion Criteria:

Body mass index > 30
Mustache, beard
Claustrophobia

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

Principal Investigator: Issam Tanoubi, M.D., Maisonneuve Rosemont Hospital, University Of Montreal
Study Director: François Donati, PhD, MD, FRCPC, Maisonneuve Rosemont Hospital, University Of Montreal
Study Chair: Pierre Drolet, MD, FRCPC, Maisonneuve Rosemont Hospital, University Of Montreal
Principal Investigator: Louis Phillipe Fortier, MSc, MD, FRCPC, Maisonneuve Rosemont Hospital, University Of Montreal