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Status unknownNCT03419104Updated Mar 13, 2018

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

An interventional study of preoperative walk test in Morbid Obesity and Weaning Failure, sponsored by Istanbul University. Status unknown at 1 site in Turkey. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-03-13.

Sponsored by Istanbul University · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Mar 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Morbid Obesity
  • Weaning Failure

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Keywords

  • bariatric surgery
  • extubation
03

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

patients between 18-60 years old patients with BMI > 40 patients undergoing Laparoscopic Sleeve Gastrectomy

Exclusion criteria

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)

04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Preoperative walk test

    Patients undergoing bariatric surgery who will complete a preoperative 60 meters 60 seconds walk test.

    Diagnostic Test: preoperative walk test

Interventions

  • Diagnostic testpreoperative walk test

    Patients undergoing bariatric surgery who will complete a preoperative 60 meters 60 seconds walk test.

05

What researchers measure

Primary outcomes

  1. extubation

    Number of participants with successful extubation and patients who does not need mechanical ventilation support

    Time frame: one hour postoperative

06

Study locations

1 of 1 sites recruiting
  • Istanbul University Cerrahpasa Medical Faculty
    Istanbul, 34500, Turkey
    Recruiting
07

References and documents

Publications

  • 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. PubMed 21719358 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03419104
Lead sponsor
Istanbul University
Responsible party
Guniz M.Koksal (Prof.Dr, Istanbul University) — Principal investigator
First posted
Feb 1, 2018
Start date
Mar 1, 2018
Primary completion
Jun 30, 2018 (estimated)
Completion
Aug 1, 2018 (estimated)
Last update
Mar 13, 2018

Study contacts

emre erbabacan, asc prof
Contact
emreerbabacan@gmail.com
5322067777
cigdem akyol, MD
Contact
akyolbeyoglu@gmail.com

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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