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NCT02220959 Clinical Trial

Is Preoperative Exercise Test in Morbid Obese Patients a Predictive Test for Extubation?

Morbid Obesity Clinical Trial

Official title:
Is Preoperative Exercise Test in Morbid Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy a Predictive Test for Extubation?

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02220959
Other study ID # 14467
Secondary ID
Status Completed
Phase N/A
First received August 18, 2014
Last updated October 9, 2014
Start date May 2014

Study information
Verified date October 2014
Source Istanbul University
Contact n/a
Is FDA regulated No
Health authority Turkey:Istanbul University
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility 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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Other:
• walk test
patients will be encouraged to walk a 60 meter distance under 1 minute and FVC will be measured before and after the walk test

Locations
Country Name City State
Turkey Cerrahpasa medical Faculty General surgery operation theatre Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants with successful extubation preoperative 60 meter walk test postoperative 30 minutes No
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