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

NCT04273074 | Completed

• 1 other identifier: D-18-2019
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

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.

Conditions

Airway Assessment

Outcome Measures

Primary Outcomes (1)

• Epiglottis-to-vocal-cord distance

  Epiglottis-to-vocal-cord distance by ultrasound

  during examination up to 1 hours

Secondary Outcomes (7)

• Tongue width

  UP TO 1 HOURE

• Modified Mallampati class

  UP TO 1 HOURE

• the time needed to perform the ultrasound examination.

  UP TO 1 HOURE

• Pre-epiglottic space

  UP TO 1 HOURE

• Pre-epiglottic space

  up to 1 hour

Study Arms (1)

preoperative sonographic assessment group

OTHER

preoperative sonographic assessment to airway

Radiation: sonographic assessment

Interventions

sonographic assessment RADIATION

preoperative sonographic assessment to airway

preoperative sonographic assessment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university

Cairo, 11451, Egypt

Location

Study Officials

• Nadia Helmy, MD

  Professor of Anaesthesia, surgical ICU &Pain management

  PRINCIPAL INVESTIGATOR

• Yasmine salah

  lecturer of Anesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia, Pain management and Surgical ICU

Study Record Dates

• First Submitted: February 13, 2020
• First Posted: February 17, 2020
• Study Start: February 20, 2020
• Primary Completion: June 23, 2021
• Study Completion: July 30, 2021
• Last Updated: September 16, 2021

Record last verified: 2021-09

Locations

EG (1)