Oxygenation and Pulmonary Function in Morbidly Obese Patients Undergoing Bariatric Surgery

Not Applicable

• Conditions: Morbid Obesity
• Interventions: Device: Boussignac TM CPAP; Device: Venturi Face Mask

• Registration Number: NCT01002599
• Lead Sponsor: University Health Network, Toronto

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-10-23
• Study First Submitted QC: 2009-10-26
• Study First Posted: 2009-10-27
• Status Verified: 2010-01
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Last Update Submitted: 2010-01-22
• Last Update Posted: 2010-01-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 54

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Boussignac TM CPAP	Boussignac TM CPAP	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.
Venturi Face Mask	Venturi Face Mask	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.

Primary Outcome Measures

Name	Time	Method
PaO2/FiO2 ratio (PF ratio) immediately on arrival to postanesthesia care unit, 1 hour, 2 hours, and 24 hours post-extubation.	24 hours

Trial Locations

Locations (1)

University Health Network; 🇨🇦 Toronto, Ontario, Canada