- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02220959
Is Preoperative Exercise Test in Morbid Obese Patients a Predictive Test for Extubation?
October 9, 2014 updated by: Guniz M.Koksal, Istanbul University
Is Preoperative Exercise Test in Morbid Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy a Predictive Test for Extubation?
the purpose of this study is to determine if 60 meter test done prior to surgery is a predictive in terms of extubation in morbid obese patients undergoing morbid obese surgery.
Study Overview
Study Type
Interventional
Enrollment (Actual)
50
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
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Istanbul, Turkey, 34500
- Cerrahpasa medical Faculty General surgery operation theatre
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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 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients between 18-60 years old
- patients with BMI > 40
- patients undergoing Laparoscopic Sleeve Gastrectomy
Exclusion Criteria:
- patients with Chronic obstructive pulmonary disease (COPD), Asthma,
- patients with uncompensated heart failure
- Uncompensated diabetes mellitus
- Patients Who have orthopedic problems that effects the exercise test
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: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: walk test
morbid obese patients (BMI>40) undergoing laparoscopic sleeve gastrectomy walking 60 meters under 1 minute before and after the measurement of Forced vital capacity (FVC)
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patients will be encouraged to walk a 60 meter distance under 1 minute and FVC will be measured before and after the walk test
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with successful extubation
Time Frame: postoperative 30 minutes
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preoperative 60 meter walk test
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postoperative 30 minutes
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
May 1, 2014
Primary Completion (Actual)
September 1, 2014
Study Registration Dates
First Submitted
August 18, 2014
First Submitted That Met QC Criteria
August 19, 2014
First Posted (Estimate)
August 20, 2014
Study Record Updates
Last Update Posted (Estimate)
October 10, 2014
Last Update Submitted That Met QC Criteria
October 9, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14467
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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