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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06457165
Other study ID # Difficult Intubation
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2021
Est. completion date January 1, 2024

Study information

Verified date June 2024
Source Ankara City Hospital Bilkent
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Prediction of difficult preoperative intubation in obese patients and completion of preparations for difficult intubation both reduce the risk of repeated intubation and prevent complications. In this study, the investigators aimed to evaluate whether anthropometric measurements are superior in defining difficult preoperative airways.


Description:

The World Health Organization (WHO) defines obesity, the incidence of which has increased significantly worldwide and is one of the important causes of difficult airway in terms of anesthesia, as obesity when the body mass index (BMI) is above 30. Access to the upper airway is difficult in obese patients, in whom excessive adipose tissue accumulates in the breast, neck, chest, and abdomen. Determining preoperative difficult intubation parameters in obese patients and entering the case preparation both reduce the risk of repeated intubation and prevent intraoperative and postoperative complications. However, there are still insufficient tests to predict difficult intubation. Many studies have shown that multiple factors such as Mallampati score, high body mass index (BMI), increased neck circumference, and the ratio of neck circumference to thyromental distance are predictors of difficult intubation in obese patients. The introduction of ultrasonography into daily use has led to the use of ultrasonographic parameters in predicting difficult intubation and laryngoscopy. In this study, the investigators aimed to evaluate whether ultrasonography is useful in defining difficult preoperative airways, in addition to anthropometric measurements.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date January 1, 2024
Est. primary completion date January 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - 18-60 years - ASA 1-3 - BMI =30 kg/m2 - ASA 1-3 - Scheduled for elective abdominal surgery under general anesthesia Exclusion Criteria: - <18 and >60 years - ASA>3 - BMI<30

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Difficult Intubation
Noted for each patient.
Not Difficult Intubation
Noted for each patient.

Locations

Country Name City State
Turkey Ankara Bilkent City Hospital Ankara

Sponsors (1)

Lead Sponsor Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Suprasternal Adipose Tissue Thickness It is predicted that it may indicate difficult intubation. within 10 minutes before going into surgery
Secondary Abdominal circumference Noted for each patient. within 10 minutes before going into surgery
Secondary Waist circumference Noted for each patient. within 10 minutes before going into surgery
Secondary Arm circumference Noted for each patient. within 10 minutes before going into surgery
Secondary Distance between incisions Noted for each patient. within 10 minutes before going into surgery
Secondary Thyromental distance measurement Noted for each patient. within 10 minutes before going into surgery
Secondary Sternomental distance measurement Noted for each patient. within 10 minutes before going into surgery
Secondary Mallampati Score Noted for each patient. within 10 minutes before going into surgery(class 1-4; 1 means good and 4 means bad)
Secondary Wilson score Noted for each patient. within 10 minutes before going into surgery(grade 0-10; 0 means good, 10 means bad)
Secondary Cormack-Lehane score Noted for each patient. 1. minute after intubation(class 1-4; 1 means good and 4 means bad)
Secondary Age Noted for each patient. within 10 minutes before going into surgery
Secondary Sex Noted for each patient. within 10 minutes before going into surgery
Secondary ASA Noted for each patient. within 10 minutes before going into surgery(grades 1-6; 1 means good and 6 means bad)
Secondary BMI Noted for each patient. within 10 minutes before going into surgery
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