Upper Airway Ultrasound in the Assessment of Difficult Visualization of the Larynx

Not Applicable

Completed

• Conditions: Airway Assessment
• Interventions: Radiation: sonographic assessment

• Registration Number: NCT04273074
• Lead Sponsor: Cairo University

Brief Summary

failed and Difficult tracheal intubation after direct laryngoscopy is a dreaded complication of general anesthesia as it is associated with serious morbidity and mortality. There are several conventional clinical airway assessment parameters such as the modified Mallampati classification,thyromental and hyomental distance, interincisor distance, neck movementsand neck circumference, which are usually used to predict a difficult airwayand are components of multivariate risk indices. Despite the use of these parameters, the diagnostic accuracy of a preanesthetic airway assessment in predicting difficult intubation is very low. Ultrasound has been evolving as a useful device for airway assessment,and sublingual ultrasound has been used for this purpose.

Detailed Description

By an anesthesiologist who is experienced in airway ultrasound, patients will preoperative sonographic assessment . the patient will lie in the ramped up position , with head in the neutral position.The linear probe of the ultrasound machine will be used. Under the patient's chin, The probe of ultrasond will be placed , at different levels, to get the of the submandibular area in transverse view and the upper part of the neck. The transverse view will be used for measuring the the skin to hyoid, tongue volume,and the skin to epiglottis distance. The mid-sagittal view will be used for measuring the distance between epiglottis ,pre-epiglottic space , vocal cords, and the neck fat volume .

Study Timeline

• Study First Submitted: 2020-02-13
• Study First Submitted QC: 2020-02-14
• Study First Posted: 2020-02-17
• Study Start: 2020-02-20
• Primary Completion: 2021-06-23
• Study Completion: 2021-07-30
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-15
• Last Update Posted: 2021-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

Inclusion Criteria

1. Adult patients above 18 years of age.
2. Both genders
3. Patients scheduled for elective surgery under general anesthesia
4. Obese patients with BMI > 30 kg/m2

Exclusion Criteria

1. Patients with psychological disorders or those lacking co-operation.
2. Patients with maxillofacial anomalies, restricted neck movements and limited mouth opening.
3. American Society of Anesthesiologists (ASA) physical status class IV
4. Emergency operations

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
preoperative sonographic assessment group	sonographic assessment	preoperative sonographic assessment to airway

Primary Outcome Measures

Name	Time	Method
Epiglottis-to-vocal-cord distance	during examination up to 1 hours	Epiglottis-to-vocal-cord distance by ultrasound

Secondary Outcome Measures

Name	Time	Method
Tongue width	UP TO 1 HOURE	by ultrasound
Modified Mallampati class	UP TO 1 HOURE	Class I: Soft palate, fauces, pillars, and uvula are visible.; Class II: Soft palate, fauces, and uvula are visible.; Class III: Soft palate and base of uvula are visible.; Class IV: Soft palate is not visible at all.; Class I and II were defined as "good view" and III and IV as "poor view" in the present study.
the time needed to perform the ultrasound examination.	UP TO 1 HOURE	by minute
Pre-epiglottic space	up to 1 hour	by ultrasound
Skin to hyoid distance	up to 1 hour	by ultrasound
Skin to epiglottis distance	up to 1 hour	by ultrasound

Trial Locations

Locations (1)

Cairo university; 🇪🇬 Cairo, Egypt