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

Point of Care Upper Airway Ultrasound in the Assessment of Difficult Visualization of the Larynx in Obese Patients Undergoing Bariatric Surgery: a Comparison With the Conventional Cormack-Lehane Classification During Direct Laryngoscopy: an Observational Study

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.

Study Overview

• Status: Completed
• Conditions: Airway Assessment
• Intervention / Treatment: Radiation: sonographic assessment

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 Type: Interventional
• Enrollment (Actual): 111
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11451
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: preoperative sonographic assessment group; preoperative sonographic assessment to airway	Radiation: sonographic assessment; preoperative sonographic assessment to airway

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epiglottis-to-vocal-cord distance	Epiglottis-to-vocal-cord distance by ultrasound	during examination up to 1 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tongue width	by ultrasound	UP TO 1 HOURE
Modified Mallampati class	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.	UP TO 1 HOURE
the time needed to perform the ultrasound examination.	by minute	UP TO 1 HOURE
Pre-epiglottic space	by ultrasound	UP TO 1 HOURE
Pre-epiglottic space	by ultrasound	up to 1 hour
Skin to hyoid distance	by ultrasound	up to 1 hour
Skin to epiglottis distance	by ultrasound	up to 1 hour

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Nadia Helmy, MD, Professor of Anaesthesia, surgical ICU &Pain management; Principal Investigator: Yasmine salah, lecturer of Anesthesiology

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 20, 2020
• Primary Completion (ACTUAL): June 23, 2021
• Study Completion (ACTUAL): July 30, 2021

Study Registration Dates

• First Submitted: February 13, 2020
• First Submitted That Met QC Criteria: February 14, 2020
• First Posted (ACTUAL): February 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 16, 2021
• Last Update Submitted That Met QC Criteria: September 15, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: D-18-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: still working

Drug and device information, study documents

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