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Oxygenation and Pulmonary Function in Morbidly Obese Patients Undergoing Bariatric Surgery

Primary Purpose

Morbid Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Boussignac TM CPAP
Venturi Face Mask
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity focused on measuring bariatric surgery, morbidly obese, BMI >35, CPAP, Venturi, Boussignac, Ventilation, Pulmonary function, Morbidly Obese Patients undergoing bariatric surgery

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Health NetworkRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Boussignac TM CPAP

Venturi Face Mask

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 23, 2009
Last Updated
January 22, 2010
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT01002599
Brief Title
Oxygenation and Pulmonary Function in Morbidly Obese Patients Undergoing Bariatric Surgery
Official Title
Does BoussignacTM CPAP Compared to Venturi Mask Improve Oxygenation and Pulmonary Function in Morbidly Obese Patients Undergoing Bariatric Surgery?
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Unknown status
Study Start Date
June 2009 (undefined)
Primary Completion Date
January 2010 (Anticipated)
Study Completion Date
January 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University Health Network, Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
Keywords
bariatric surgery, morbidly obese, BMI >35, CPAP, Venturi, Boussignac, Ventilation, Pulmonary function, Morbidly Obese Patients undergoing bariatric surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Boussignac TM CPAP
Arm Type
Experimental
Arm Description
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.
Arm Title
Venturi Face Mask
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Boussignac TM CPAP
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Venturi Face Mask
Intervention Description
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 Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Wong, MD
Phone
4166035118
Email
david.wong@uhn.on.ca
Facility Information:
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Wong, MD
Phone
4166035118
Email
david.wong@uhn.on.ca

12. IPD Sharing Statement

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Oxygenation and Pulmonary Function in Morbidly Obese Patients Undergoing Bariatric Surgery

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