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NCT Number: NCT00922753

Inspiratory Support Improves Preoxygenation in Healthy Subjects

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.

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Key information

Conditions

Healthy Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maisonneuve Rosemont Hospital

Montreal, Quebec, H1T 2M4, Canada

About this study

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%.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy volunteers
  • Aged between 20 to 40 years

Exclusion criteria

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

Treatment and study plan

VS

Other

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

AI-4/PEEP-4

Other

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

AI-6/PEEP-4

Other

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.

Primary outcomes

  1. expiratory oxygen fraction (end-tidal 02)

Secondary outcomes

  1. inspiratory oxygen fraction

  2. end-tidal CO2

  3. tidal volume

  4. inspiratory pressure

  5. subject's tolerance

  6. leaks around the mask during preoxygenation

  7. minute volume

  8. endexpiratory pressure

Sponsors and collaborators

Lead sponsor

Maisonneuve-Rosemont Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Jun 17, 2009
Registry last updated
Jun 18, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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