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Clinical Trials/NCT04273074
NCT04273074
Completed
Not Applicable

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

Cairo University1 site in 1 country111 target enrollmentFebruary 20, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Airway Assessment
Sponsor
Cairo University
Enrollment
111
Locations
1
Primary Endpoint
Epiglottis-to-vocal-cord distance
Status
Completed
Last Updated
4 years ago

Overview

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 .

Registry
clinicaltrials.gov
Start Date
February 20, 2020
End Date
July 30, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Amr Samir Wahdan

Lecturer of Anesthesia, Pain management and Surgical ICU

Cairo University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Epiglottis-to-vocal-cord distance

Time Frame: during examination up to 1 hours

Epiglottis-to-vocal-cord distance by ultrasound

Secondary Outcomes

  • Skin to hyoid distance(up to 1 hour)
  • 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 hour)
  • Skin to epiglottis distance(up to 1 hour)

Study Sites (1)

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