Oxygenation and Pulmonary Function in Morbidly Obese Patients Undergoing Bariatric Surgery

University Health Network, Toronto

Status: Unknown

Conditions: Morbid Obesity

Treatments: Device: Venturi Face Mask; Device: Boussignac TM CPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT01002599

09-0160-B

Details and patient eligibility

About

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.

Enrollment: 54 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

Boussignac TM CPAP

Experimental group

Description:

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.

Treatment:

Device: Boussignac TM CPAP

Venturi Face Mask

Active Comparator group

Description:

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.

Treatment:

Device: Venturi Face Mask