Oxygenation and Pulmonary Function in Morbidly Obese Patients Undergoing Bariatric Surgery

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01002599

Enrollment

Registered

2009-10-27

Start date

2009-06-30

Completion date

2010-01-31

Last updated

2010-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morbid Obesity

Keywords

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

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.

Interventions

DEVICEBoussignac 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.

DEVICEVenturi 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	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

Countries

Canada

Contacts

Primary ContactDavid Wong, MD

david.wong@uhn.on.ca4166035118

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026