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Sponsored by: |
Maisonneuve-Rosemont Hospital |
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Information provided by: | Maisonneuve-Rosemont Hospital |
ClinicalTrials.gov Identifier: | NCT00673634 |
The purpose of this clinical trial is to evaluate whether pre-oxygenation of obese patients with BiPAP 4cm H2O, renders any benefit to the quality of pre-oxygenation measured by the expired oxygen fraction (FeO2) and whether it is as well tolerated as the traditional method of spontaneous breathing for 3 minutes.
Condition | Intervention |
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Obesity |
Procedure: Standard preoxygenation Procedure: BiPAP assisted preoxygenation |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Crossover Assignment, Safety/Efficacy Study |
Official Title: | Efficiency of Preoxygenation in Obese Patients: Evaluation of Traditional Method Versus Pressure Assisted Preoxygenation. |
Enrollment: | 30 |
Study Start Date: | March 2008 |
Study Completion Date: | May 2008 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Standard preoxygenation
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Procedure: Standard preoxygenation
Spontaneous breathing of 100% oxygen in a facemask for 3 minutes.
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2: Active Comparator
BiPAP assisted preoxygenation
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Procedure: BiPAP assisted preoxygenation
Spontaneous breathing of 100% oxygen in a facemask with application of an inspiratory pressure of 4cm H2O and a positive end-expiratory pressure of 4cm H2O, for 3 minutes.
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Traditional pre-oxygenation in obese patients has been proven to allow a time of apnea far reduced when compared with patients closer to their ideal body weight. This effect is attributable to several factors :
Yet, few studies have evaluated BiPAP in the operating room setting as to the effect on FeO2 and to the tolerance by the patients.
Thus, it is our intent to evaluate the efficiency of application of an inspiratory assistance pressure of 4cmH2O and PEEP 4cmH2O during a 3 minutes pre-oxygenation trial as to the level of FeO2 attained, the rate of attainment of FeO2 > 90% and the tolerance by the patient of the procedure, when compared with a 3 minute trial of the traditional method.
For this purpose, consenting, non pre-medicated obese patients scheduled for surgery in the operating ward of our institution will be brought earlier to the operating room, the day of their surgery. In an idle operating room, they will go through two trials of 100% O2 pre-oxygenation lasting 3 minutes each, at an interval of 20 minutes during which the patients will rest in a semi-sitting position, breathing spontaneously at ambient air. The order of the two trials will be randomly assigned between standard pre-oxygenation vs BiPAP pre-oxygenation. Both patients and anesthesia assistants providing the pre-oxygenation will be blinded as to the ongoing trial. Data from the anesthesia machine will be recorded visually to be analysed subsequently by a blinded third party. During each trial, the comfort of the patient on a local 4 point scale will be graded every minute.
At the end of the study period, patients will be returned to the waiting area of the operating ward before the scheduled time of their surgery. The protocol is intended to not interfere with the planned anesthesia technique or the surgery in any way.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Quebec | |
Maisonneuve-Rosemont Hospital | |
Montreal, Quebec, Canada, H1T 2M4 |
Study Director: | Pierre Drolet, MD, FRCPC | Maisonneuve-Rosemont Hospital |
Principal Investigator: | Mihai L Georgescu, MD, resident | Maisonneuve-Rosemont Hospital / Université de Montréal |
Responsible Party: | Maisonneuve-Rosemont Hospital / Université de Montréal ( Mihai Georgescu / anesthesiology resident ) |
Study ID Numbers: | 07122 |
Study First Received: | May 5, 2008 |
Last Updated: | June 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00673634 |
Health Authority: | Canada: Canadian Institutes of Health Research |
preoxygenation method efficiency |
obesity BiPAP FeO2 |
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overweight Overnutrition |