NCT03419104

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 1, 2018

Completed
28 days until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

March 13, 2018

Status Verified

March 1, 2018

Enrollment Period

4 months

First QC Date

January 26, 2018

Last Update Submit

March 12, 2018

Conditions

Morbid ObesityWeaning Failure

Keywords

bariatric surgeryextubation

Outcome Measures

Primary Outcomes (1)

  • extubation

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

    one hour postoperative

Study Arms (1)

Preoperative walk test

EXPERIMENTAL

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

Diagnostic Test: preoperative walk test

Interventions

preoperative walk testDIAGNOSTIC_TEST

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

Preoperative walk test

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University Cerrahpasa Medical Faculty

Istanbul, 34500, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • 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.

    PMID: 21719358RESULT

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

emre erbabacan, asc prof

CONTACT

5322067777emreerbabacan@gmail.com

cigdem akyol, MD

CONTACT

akyolbeyoglu@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.Dr

Study Record Dates

First Submitted

January 26, 2018

First Posted

February 1, 2018

Study Start

March 1, 2018

Primary Completion

June 30, 2018

Study Completion

August 1, 2018

Last Updated

March 13, 2018

Record last verified: 2018-03

Locations

TU(1)