Inspiratory Support Improves Preoxygenation in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
Maisonneuve-Rosemont Hospital
ClinicalTrials.gov Identifier:
NCT00922753
First received: June 16, 2009
Last updated: June 17, 2009
Last verified: June 2009
  Purpose

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 Intervention
Healthy
Other: VS
Other: AI-4/PEEP-4
Other: AI-6/PEEP-4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: The Efficacy and Tolerability of Different Levels of Inspiratory Support and PEEP During Preoxygenation. A Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Maisonneuve-Rosemont Hospital:

Primary Outcome Measures:
  • expiratory oxygen fraction (end-tidal 02) [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • inspiratory oxygen fraction [ Designated as safety issue: Yes ]
  • end-tidal CO2 [ Designated as safety issue: Yes ]
  • tidal volume [ Designated as safety issue: Yes ]
  • inspiratory pressure [ Designated as safety issue: Yes ]
  • subject's tolerance [ Designated as safety issue: Yes ]
  • leaks around the mask during preoxygenation [ Designated as safety issue: Yes ]
  • minute volume [ Designated as safety issue: Yes ]
  • endexpiratory pressure [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: February 2007
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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%.

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers
  • Aged between 20 to 40 years

Exclusion Criteria:

  • Body mass index > 30
  • Mustache, beard
  • Claustrophobia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00922753

Locations
Canada, Quebec
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
  More Information

Additional Information:
Publications:

Responsible Party: Tanoubi Issam, M.D., Maisonneuve-Rosemont Hospital, Department Of Anesthesiology
ClinicalTrials.gov Identifier: NCT00922753     History of Changes
Other Study ID Numbers: 06109
Study First Received: June 16, 2009
Last Updated: June 17, 2009
Health Authority: Canada: Health Canada
Canada: Canadian Institutes of Health Research
Canada: Ethics Review Committee

Keywords provided by Maisonneuve-Rosemont Hospital:
Preoxygenation
Inspiratory
Support
Healthy
EndtidalO2

Additional relevant MeSH terms:
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014