Recruiting

Observational Study

Sponsor:

University Health Network, Toronto

Code:

NCT01002599

Conditions

Morbid Obesity

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Boussignac TM CPAP

Venturi Face Mask

Study Details

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

Study ID

NCT01002599

Start date

Jun, 2009

Status verified date

Jan, 2010

Completion date

Jan, 2010

Anticipated

Primary completion date

Jan, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

54 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: 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.

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

David Wong, MD

4166035118david.wong@uhn.on.ca

Locations

University Health Network

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

David Wong, MD

4166035118david.wong@uhn.on.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Jan 26, 2010

Last verified

Jan, 2010

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2010-01-26.