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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00673634 |
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Date of registration:
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05/05/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficiency of Preoxygenation in Obese Patients: Pressure Assisted Versus Traditional Method
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Scientific title:
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Efficiency of Preoxygenation in Obese Patients: Evaluation of Traditional Method Versus Pressure Assisted Preoxygenation. |
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Date of first enrolment:
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March 2008 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00673634 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention
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Phase:
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N/A
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Countries of recruitment
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Canada
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Contacts
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Name:
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Pierre Drolet, MD, FRCPC |
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Address:
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Telephone:
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Email:
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Affiliation:
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Maisonneuve-Rosemont Hospital |
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Name:
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Mihai L Georgescu, MD, resident |
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Address:
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Telephone:
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Email:
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Affiliation:
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Maisonneuve-Rosemont Hospital / Université de Montréal |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- BMI > 30
- Scheduled for surgery
Exclusion Criteria:
- Non fasted patient
- Clinically significant gastro-oesophageal reflux
- Intestinal occlusion
- Presence of nasogastric tube
- Facial hair
- Claustrophobia
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Obesity
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Intervention(s)
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Procedure: Standard preoxygenation
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Procedure: BiPAP assisted preoxygenation
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Primary Outcome(s)
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rate of increase of fractional expired oxygen level
[Time Frame: every 10 seconds during each 3 minute preoxygenation period]
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Secondary Outcome(s)
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Level of fractional expired oxygen. Patient tolerance. Ease of preoxygenation administration. Presence of secondary effects (gastric reflux, respiratory discomfort, burps)
[Time Frame: every minute during each 3 minute preoxygenation trial and at the end of each trial]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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