Oxygenation and Pulmonary Function in Morbidly Obese Patients Undergoing Bariatric Surgery

January 22, 2010 updated by: University Health Network, Toronto

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Recruiting
        • University Health Network
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Anticipated)

January 1, 2010

Study Completion (Anticipated)

January 1, 2010

Study Registration Dates

First Submitted

October 23, 2009

First Submitted That Met QC Criteria

October 26, 2009

First Posted (Estimate)

October 27, 2009

Study Record Updates

Last Update Posted (Estimate)

January 26, 2010

Last Update Submitted That Met QC Criteria

January 22, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-0160-B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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