Back to resultsPreoperative Exercise Test and Postoperative Intensive Care Unit Need in Bariatric Surgery
Primary Purpose
Morbid Obesity, Weaning Failure
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
preoperative walk test
Sponsored by
About this trial
This is an interventional diagnostic trial for Morbid Obesity focused on measuring bariatric surgery, extubation
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) or Asthma, patients with uncompensated heart failure Patients Who have orthopedic problems that effects the exercise test (such as gonarthrosis)
Sites / Locations
- Istanbul University Cerrahpasa Medical FacultyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Preoperative walk test
Arm Description
Patients undergoing bariatric surgery who will complete a preoperative 60 meters 60 seconds walk test.
Outcomes
Primary Outcome Measures
extubation
Number of participants with successful extubation and patients who does not need mechanical ventilation support
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03419104
Brief Title
Preoperative Exercise Test and Postoperative Intensive Care Unit Need in Bariatric Surgery
Official Title
Use of Preoperative Exercise Test as Predictor for Postoperative Intensive Care Unit Need in Patients Undergoing Bariatric Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
June 30, 2018 (Anticipated)
Study Completion Date
August 1, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of our study is to evaluate the efficacy of "60 meters 60 seconds exercise test" (a test designed by the study group) done preoperatively as a predictor test for postoperative intensive care unit need and extubation success in patients undergoing bariatric surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity, Weaning Failure
Keywords
bariatric surgery, extubation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Preoperative walk test
Arm Type
Experimental
Arm Description
Patients undergoing bariatric surgery who will complete a preoperative 60 meters 60 seconds walk test.
Intervention Type
Diagnostic Test
Intervention Name(s)
preoperative walk test
Intervention Description
Patients undergoing bariatric surgery who will complete a preoperative 60 meters 60 seconds walk test.
Primary Outcome Measure Information:
Title
extubation
Description
Number of participants with successful extubation and patients who does not need mechanical ventilation support
Time Frame
one hour postoperative
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) or Asthma, patients with uncompensated heart failure Patients Who have orthopedic problems that effects the exercise test (such as gonarthrosis)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
emre erbabacan, asc prof
Phone
5322067777
Email
emreerbabacan@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
cigdem akyol, MD
Email
akyolbeyoglu@gmail.com
Facility Information:
Facility Name
Istanbul University Cerrahpasa Medical Faculty
City
Istanbul
ZIP/Postal Code
34500
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
emre erbabacan, asc prof
Phone
5322067777
Email
emreerbabacan@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
21719358
Citation
Gupta PK, Gupta H, Kaushik M, Fang X, Miller WJ, Morrow LE, Armour-Forse R. Predictors of pulmonary complications after bariatric surgery. Surg Obes Relat Dis. 2012 Sep-Oct;8(5):574-81. doi: 10.1016/j.soard.2011.04.227. Epub 2011 May 13.
Results Reference
result
Learn more about this trial
Preoperative Exercise Test and Postoperative Intensive Care Unit Need in Bariatric Surgery
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