Oxygenation and Pulmonary Function in Morbidly Obese Patients Undergoing Bariatric Surgery

Morbid Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01002599
• Other study ID #: 09-0160-B
• Status: Recruiting
• Phase: N/A
• First received: October 23, 2009
• Last updated: January 22, 2010
• Start date: June 2009
• Est. completion date: January 2010

Study information

• Verified date: January 2010
• Source: University Health Network, Toronto
• Contact: David Wong, MD
• Phone: 4166035118
• Email: david.wong[@]uhn.on.ca
• Is FDA regulated: No
• Health authority: Canada: Canadian REB
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

Device:
• 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
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.

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PaO2/FiO2 ratio (PF ratio) immediately on arrival to postanesthesia care unit, 1 hour, 2 hours, and 24 hours post-extubation.		24 hours	No