NCT02220959

Brief 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.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 20, 2014

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Last Updated

October 10, 2014

Status Verified

October 1, 2014

Enrollment Period

4 months

First QC Date

August 18, 2014

Last Update Submit

October 9, 2014

Conditions

Morbid Obesity

Keywords

morbid obesity surgerywalk testexercise

Outcome Measures

Primary Outcomes (1)

  • Number of participants with successful extubation

    preoperative 60 meter walk test

    postoperative 30 minutes

Study Arms (1)

walk test

EXPERIMENTAL

morbid obese patients (BMI\>40) undergoing laparoscopic sleeve gastrectomy walking 60 meters under 1 minute before and after the measurement of Forced vital capacity (FVC)

Other: walk test

Interventions

walk testOTHER

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

Also known as: 60 meter walk test
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), Asthma,
  • patients with uncompensated heart failure
  • Uncompensated diabetes mellitus
  • Patients Who have orthopedic problems that effects the exercise test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cerrahpasa medical Faculty General surgery operation theatre

Istanbul, 34500, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity, MorbidMotor Activity

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

August 18, 2014

First Posted

August 20, 2014

Study Start

May 1, 2014

Primary Completion

September 1, 2014

Last Updated

October 10, 2014

Record last verified: 2014-10

Locations

TU(1)