Oxygenation and Pulmonary Function in Morbidly Obese Patients Undergoing Bariatric Surgery

NCT ID: NCT01002599

Last Updated: 2010-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Morbid Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Boussignac TM CPAP

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Venturi Face Mask

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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University Health Network

Locations

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University Health Network

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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David Wong, MD

Role: CONTACT

4166035118

Facility Contacts

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David Wong, MD

Role: primary

4166035118

Other Identifiers

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09-0160-B

Identifier Type: -

Identifier Source: org_study_id

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