Preoperative Evaluation of Airway

Evaluation of Airway on Undervent Bariatric Surgery Patients

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

Study Overview

• Status: Completed
• Conditions: Obesity; Difficult Intubation
• Intervention / Treatment: Other: obese patients

Detailed Description

The investigators evaluated the airway parameters recorded preoperatively for patients with BMI> 30 who were undervent bariatric surgery between 2015-2018 in terms of difficult airway.

• Study Type: Interventional
• Enrollment (Actual): 489
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. BMI>30kg/m2
2. 18<age <65
3. elective surgery planned
4. ASA II-III

Exclusion Criteria:

1. BMI<30kg/m2
2. 18>age >65
3. ASA IV

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: obese patient; BMI>30 kg/m2 and underwent bariatric surgery	Other: obese patients; underwent bariatric surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Yeditepe University Hospital
• Investigators: Principal Investigator: nurcan kizilcik, Yeditepe UH

Publications and helpful links

General Publications

• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: May 16, 2018
• First Submitted That Met QC Criteria: July 21, 2018
• First Posted (Actual): July 24, 2018

Study Record Updates

• Last Update Posted (Actual): July 24, 2018
• Last Update Submitted That Met QC Criteria: July 21, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: difficult airway, obese patient,
• Other Study ID Numbers: YeditepeUH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: For the protection of personal data, was decided that the personal data of the participants should not be shared .
• IPD Sharing Time Frame: 3 years
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No