NCT03597880

Brief Summary

Evaluation of airway markers of patients who have undergone obesity surgery.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
489

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable obesity

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

January 1, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 24, 2018

Completed
Last Updated

July 24, 2018

Status Verified

July 1, 2018

Enrollment Period

3 years

First QC Date

May 16, 2018

Last Update Submit

July 21, 2018

Conditions

Keywords

difficult airway, obese patient,

Outcome Measures

Primary Outcomes (4)

  • airway evaluation for menagement in obese patient

    preoperative airway measurements routinely performed (mallampati score, thyromental distance, neck circumference ..)for each patient will be evaluated

    3 year

  • mallampati score

    Class I : Visualization of the soft palate, fauces; uvula, anterior and the posterior pillars. Class II : Visualization of the soft palate, fauces and uvula. Class III : Visualization of soft palate and base of uvula. Class IV: Only hard palate is visible. Soft palate is not visible at all.

    3 year

  • thyromental distance

    TMD was measured as straight distance between thyroid notch and lower border of mental prominence.(cm)

    3 year

  • neck circumference

    Neck Circumference was measured in the midway of the neck, between mid-cervical spine and mid anterior neck, to within 1 mm, using non-stretchable plastic tape with the subjects standing upright.

    3 year

Study Arms (1)

obese patient

OTHER

BMI\>30 kg/m2 and underwent bariatric surgery

Other: obese patients

Interventions

underwent bariatric surgery

obese patient

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI\>30kg/m2
  • \<age \<65
  • elective surgery planned
  • ASA II-III

You may not qualify if:

  • BMI\<30kg/m2
  • \>age \>65
  • ASA IV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Langeron O, Birenbaum A, Le Sache F, Raux M. Airway management in obese patient. Minerva Anestesiol. 2014 Mar;80(3):382-92. Epub 2013 Oct 14.

Related Links

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • nurcan kizilcik

    Yeditepe UH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
SCREENING
Intervention Model
SEQUENTIAL
Model Details: retrospective clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist.Prof.Dr.

Study Record Dates

First Submitted

May 16, 2018

First Posted

July 24, 2018

Study Start

January 1, 2015

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

July 24, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will share

For the protection of personal data, was decided that the personal data of the participants should not be shared .

Shared Documents
STUDY PROTOCOL
Time Frame
3 years