Preoperative Exercise Test and Postoperative Intensive Care Unit Need in Bariatric Surgery

March 12, 2018 updated by: Guniz M.Koksal, Istanbul University

Use of Preoperative Exercise Test as Predictor for Postoperative Intensive Care Unit Need in Patients Undergoing Bariatric Surgery

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

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 Contact

Study Contact Backup

Study Locations

  • Turkey
      • Istanbul, Turkey, 34500
        • Recruiting
        • Istanbul University Cerrahpasa Medical Faculty
        • Contact:

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) or Asthma, patients with uncompensated heart failure Patients Who have orthopedic problems that effects the exercise test (such as gonarthrosis)

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Preoperative walk test
Patients undergoing bariatric surgery who will complete a preoperative 60 meters 60 seconds walk test.
Diagnostic test: preoperative walk test
Patients undergoing bariatric surgery who will complete a preoperative 60 meters 60 seconds walk test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
extubation
Time Frame: one hour postoperative
Number of participants with successful extubation and patients who does not need mechanical ventilation support
one hour postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

March 1, 2018

Primary Completion (Anticipated)

June 30, 2018

Study Completion (Anticipated)

August 1, 2018

Study Registration Dates

First Submitted

January 26, 2018

First Submitted That Met QC Criteria

January 26, 2018

First Posted (Actual)

February 1, 2018

Study Record Updates

Last Update Posted (Actual)

March 13, 2018

Last Update Submitted That Met QC Criteria

March 12, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IstanbulU ctf

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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