Use of USG in Difficult Airway in Obese

Sponsor

Balikesir University (Other)

Overall Status

Completed

CT.gov ID

NCT05896098

Collaborator

(none)

Enrollment

Locations

Actual Duration (Months)

Patient Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Other: Ultrasound

Detailed Description

Materials and Methods: 157 patients who will undergo elective surgery under general anesthesia, ages between 18-80, BMI ≥ 30 kg/m2, ASA I-III 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.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

2 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 1, 2020

Actual Primary Completion Date :

Mar 30, 2022

Actual Study Completion Date :

Aug 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Easy laryngoscopy Cormack Lehane Classification 1-2a	Other: Ultrasound Measurement of the airway by ultrasound in obese patients.
Difficult laryngoscopy Cormack Lehane Classification 2b-3-4	Other: Ultrasound Measurement of the airway by ultrasound in obese patients.

Arm

Intervention/Treatment

Easy laryngoscopy

Cormack Lehane Classification 1-2a

Other: Ultrasound

Measurement of the airway by ultrasound in obese patients.

Difficult laryngoscopy

Cormack Lehane Classification 2b-3-4

Other: Ultrasound

Measurement of the airway by ultrasound in obese patients.

Outcome Measures

Primary Outcome Measures

Difficult laryngoscopy [preoperative evaluation]
To determine the difficult airway in obese patients with 3 levels of anterior soft tissue measurement (cm) with ultrasound.

Secondary Outcome Measures

Difficult mask ventilation [preoperative evaluation]
To determine the difficult airway in obese patients with 3 levels of anterior soft tissue measurement (cm) with ultrasound.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

Facial and cervical trauma, head and neck malignancy, tracheostomy and thyroid surgery, non-cooperate patients, parturients, difficult airway history, intubation after two and more attempts and using assist maneuver and device.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Balikesir University	Balıkesir		Turkey	10145
2	Medical faculty	Balıkesir		Turkey

Sponsors and Collaborators

Balikesir University

Investigators

Principal Investigator: Nazan Kocaoglu, Balikesir University

Study Documents (Full-Text)

Study Protocol - Feb 27, 2020

More Information

Additional Information:

Publications

None provided.

Responsible Party:

Nazan KOCAOGLU, Assistant Professor, Balikesir University

ClinicalTrials.gov Identifier:

NCT05896098

Other Study ID Numbers:

2020/16

First Posted:

Jun 9, 2023

Last Update Posted:

Jun 9, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Nazan KOCAOGLU, Assistant Professor, Balikesir University

obesity ultrasound difficult airway

Additional relevant MeSH terms:

Obesity

Study Results

No Results Posted as of Jun 9, 2023