Morbid ObesityNCT01002599
Oxygenation and Pulmonary Function in Morbidly Obese Patients Undergoing Bariatric Surgery
A study testing Boussignac TM CPAP and Venturi Face Mask in people with Morbid Obesity, run by University Health Network, Toronto at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Boussignac TM CPAP and Venturi Face Mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2009to Jan 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University Health Network
Toronto, Ontario, M5T 2S8
David Wong, MD, 4166035118, david.wong@uhn.on.ca
About this study
Official title: 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.
- Conditions
- Morbid Obesity
- Being tested
- Boussignac TM CPAP, Venturi Face Mask
- Keywords
- bariatric surgery, morbidly obese, BMI >35, CPAP, Venturi, Boussignac, Ventilation, Pulmonary function, Morbidly Obese Patients undergoing bariatric surgery
- Medical subject headings
- Obesity, Morbid, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boussignac TM CPAPDevice
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 MaskDevice
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 group | Role | What they receive |
|---|---|---|
| Boussignac TM CPAP | Experimental | 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. Receives: Device: Boussignac TM CPAP |
| Venturi Face Mask | Active comparator | 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. Receives: Device: Venturi Face Mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
PaO2/FiO2 ratio (PF ratio) immediately on arrival to postanesthesia care unit, 1 hour, 2 hours, and 24 hours post-extubation.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2009 (estimated)
- Study startJun 2009
- Primary completionJan 2010 (estimated)
- Study completionJan 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01002599
- Sponsor's protocol ID
- 09-0160-B
- Status last verified
- Jan 2010
- First submitted
- 23 Oct 2009
- Last updated
- 26 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does BoussignacTM CPAP Compared to Venturi Mask Improve Oxygenation and Pulmonary Function in Morbidly Obese Patients Undergoing Bariatric Surgery?
- ClinicalTrials.gov ID
- NCT01002599
- Acronym / sponsor ID
- 09-0160-B
- Conditions
- Morbid Obesity
- Keywords
- bariatric surgery, morbidly obese, BMI >35, CPAP, Venturi, Boussignac, Ventilation, Pulmonary function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jan 2010 (estimated)
- Study completion
- Jan 2010 (estimated)
- First posted
- 27 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Boussignac TM CPAP | Experimental | Device: Boussignac TM CPAPPost-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 | Active comparator | Device: Venturi Face MaskPost-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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Boussignac TM CPAPPost-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 |
| Venturi Face MaskPost-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 |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Boussignac TM CPAP and Venturi Face Mask in people with Morbid Obesity, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Wong, MD (4166035118, david.wong@uhn.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2010.