Oxygenation and Pulmonary Function in Morbidly Obese Patients Undergoing Bariatric Surgery

Study Overview
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Brief Summary
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This is a randomized controlled study in which morbidly obese patients undergoing bariatric surgery will be recruited in the preoperative clinic. Patients will be randomized into 2 groups to receive oxygen with Boussignac TM continuous positive airway pressure (CPAP) or conventional Venturi mask postoperatively immediately after extubation. The objective of the study is to examine if Boussignac TM CPAP results in improved oxygenation versus Venturi face mask when it is applied immediately after extubation in morbidly obese patients post bariatric surgery.

Official Title
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Does BoussignacTM CPAP Compared to Venturi Mask Improve Oxygenation and Pulmonary Function in Morbidly Obese Patients Undergoing Bariatric Surgery?

Conditions
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Morbid Obesity

Intervention / Treatment
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* Device: Boussignac TM CPAP
* Device: Venturi Face Mask


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient aged between 18 to 75 years of age American Society of Anesthesiologists' (ASA) class I to III Morbidly obese with a body mass index > 35 kg/m2 Patients undergoing bariatric surgery Exclusion Criteria: Patient refusal Pre-existing cardiac failure, asthma, chronic obstructive pulmonary disease or interstitial pulmonary disease Systolic blood pressure less than 90 mmHg despite pharmacotherapy Hb < 70 g/L Impaired gastric emptying Severe psychiatric disorder Language barrier

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Boussignac TM CPAP<br>Post-operative patients will be fitted with a Boussignac TM CPAP mask immediately after extubation and oxygenation and pulmonary function will be measured over a 24 hour period. | Device: Boussignac TM CPAP<br>* Post-operative patients will be fitted with a Boussignac TM CPAP mask immediately after extubation and oxygenation and pulmonary function will be measured over a 24 hour period.<br>|
| Active Comparator: Venturi Face Mask<br>Post-operative patients will be fitted with a Venturi face mask immediately after extubation and oxygenation and pulmonary function will be measured over a 24 hour period. | Device: Venturi Face Mask<br>* Post-operative patients will be fitted with a Venturi face mask immediately after extubation and oxygenation and pulmonary function will be measured over a 24 hour period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PaO2/FiO2 ratio (PF ratio) immediately on arrival to postanesthesia care unit, 1 hour, 2 hours, and 24 hours post-extubation. |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bariatric surgery, morbidly obese, BMI >35, CPAP, Venturi, Boussignac, Ventilation, Pulmonary function, Morbidly Obese Patients undergoing bariatric surgery