Back to resultsIs Preoperative Exercise Test in Morbid Obese Patients a Predictive Test for Extubation?
Primary Purpose
Morbid Obesity
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
walk test
Sponsored by
About this trial
This is an interventional diagnostic trial for Morbid Obesity focused on measuring morbid obesity surgery, walk test, exercise
Eligibility Criteria
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
Sites / Locations
- Cerrahpasa medical Faculty General surgery operation theatre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
walk test
Arm Description
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)
Outcomes
Primary Outcome Measures
Number of participants with successful extubation
preoperative 60 meter walk test
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02220959
Brief Title
Is Preoperative Exercise Test in Morbid Obese Patients a Predictive Test for Extubation?
Official Title
Is Preoperative Exercise Test in Morbid Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy a Predictive Test for Extubation?
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
Keywords
morbid obesity surgery, walk test, exercise
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
walk test
Arm Type
Experimental
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
walk test
Other Intervention Name(s)
60 meter walk test
Intervention Description
patients will be encouraged to walk a 60 meter distance under 1 minute and FVC will be measured before and after the walk test
Primary Outcome Measure Information:
Title
Number of participants with successful extubation
Description
preoperative 60 meter walk test
Time Frame
postoperative 30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Cerrahpasa medical Faculty General surgery operation theatre
City
Istanbul
ZIP/Postal Code
34500
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Is Preoperative Exercise Test in Morbid Obese Patients a Predictive Test for Extubation?
We'll reach out to this number within 24 hrs