Use of USG in Difficult Airway in Obese

Obesity Clinical Trial

Official title:

Effectiveness of Ultrasonography for the Evaluation of Difficult Airway in Obese Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05896098
• Other study ID #: 2020/16
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: August 30, 2022

Study information

• Verified date: June 2023
• Source: Balikesir University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Introduction and Purpose: Obesity is an increasing public health problem all over the world. Obesity is a proinflammatory multisystemic disease defined as hypertrophy and/or hyperplasia of adipose tissue. Obesity is frequently encountered in elective and emergency surgical procedures and causes more difficulties in airway management. Difficult airway, characterized by difficult mask ventilation and difficult intubation, is especially common in obese and morbidly obese patients. Some studies show that the measurement of anterior neck soft tissue thickness at the level of the vocal cords plays an important role in estimating difficult laryngoscopy in obese patients. Difficult intubation is envisaged in patients with pretracheal soft tissue thickness of 28 mm and neck circumference of more than 50 cm at the level of the vocal cord.

In this prospective observational study, it is aimed to measure the preoperative anterior cervical soft tissue thickness with 3 parameters by USG in obese patients undergoing elective surgery, and to evaluate the relationship of these values with the Han Scale and Cormack-Lehane classification and their effectiveness as an indicator of difficult airway.

Description:

Materials and Methods: 157 patients who will undergo elective surgery under general anesthesia, ages between 18-80, BMI ≥ 30 kg/m2, ASA I-II were included in the study. During the preoperative evaluation, patients' gender, age, height, weight, type of surgery, BMI, neck circumference, thyromental distance (TMM), sternomental distance (SMM), hyomental distance (HMM), neck extension, mouth opening and distance between incisors were measured and tooth structure was evaluated. OSAS was evaluated based on the ASA physical condition score and AHI. Mallampati Classification was recorded. Upper lip bite test was performed. Ultrasonographic measurements were made with the patient in the supine position and the head and neck in a neutral position. The Han Scale was used to evaluate difficult mask ventilation. The laryngoscopy image was evaluated and recorded with the Cormack-Lehane Classification, and ≥2b was accepted as difficult laryngoscopy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: August 30, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Elective surgery, ages between 18-80 BMI over 30, ASA I-II

Exclusion Criteria:

• Facial and cervical trauma, head and neck malignancy, tracheostomy and thyroid surgery, non-cooperate patients, parturients, difficult airway history.

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• Ultrasound
Measurement of the airway by ultrasound in obese patients.

Locations

Country	Name	City	State
Turkey	Balikesir University	Balikesir
Turkey	Medical faculty	Balikesir

Sponsors (1)

Lead Sponsor	Collaborator
Balikesir University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difficult laryngoscopy	To determine the difficult airway in obese patients with 3 levels of anterior soft tissue measurement (cm) with ultrasound.	preoperative evaluation
Secondary	Difficult mask ventilation	To determine the difficult airway in obese patients with 3 levels of anterior soft tissue measurement (cm) with ultrasound.	preoperative evaluation

External Links

•   Development of a scoring system for predicting difficult intubation using ultrasonography
•   Ultrasound As A New Tool In The Assessment Of Airway Difficulties: An Observational Study.