Oxygenation and Pulmonary Function in Morbidly Obese Patients Undergoing Bariatric Surgery

NCT01002599 | Unknown

• 1 other identifier: 09-0160-B
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Morbid Obesity

Keywords

bariatric surgery; morbidly obese; BMI >35; CPAP; Venturi; Boussignac; Ventilation; Pulmonary function; Morbidly Obese Patients undergoing bariatric surgery

Outcome Measures

Primary Outcomes (1)

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

  24 hours

Study Arms (2)

Boussignac TM CPAP

EXPERIMENTAL

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

Venturi Face Mask

ACTIVE COMPARATOR

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

Interventions

Boussignac TM CPAP DEVICE

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.

Boussignac TM CPAP

Venturi Face Mask DEVICE

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.

Venturi Face Mask

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

MeSH Terms

Conditions

Obesity, Morbid; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes

Central Study Contacts

David Wong, MD

CONTACT

4166035118; david.wong@uhn.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 23, 2009
• First Posted: October 27, 2009
• Study Start: June 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: January 26, 2010

Record last verified: 2010-01

Locations

CA (1)