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Completed

NCT Number: NCT04273074

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

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.

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Key information

Conditions

Airway Assessment

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo university

Cairo, 11451, Egypt

About this study

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 .

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sonographic assessment

Radiation

preoperative sonographic assessment to airway

Primary outcomes

  1. Epiglottis-to-vocal-cord distance

    Time frame: during examination up to 1 hours

    Epiglottis-to-vocal-cord distance by ultrasound

Secondary outcomes

  1. Tongue width

    Time frame: UP TO 1 HOURE

    by ultrasound

  2. Modified Mallampati class

    Time frame: 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.

  3. the time needed to perform the ultrasound examination.

    Time frame: UP TO 1 HOURE

    by minute

  4. Pre-epiglottic space

    Time frame: UP TO 1 HOURE

    by ultrasound

  5. Pre-epiglottic space

    Time frame: up to 1 hour

    by ultrasound

  6. Skin to hyoid distance

    Time frame: up to 1 hour

    by ultrasound

  7. Skin to epiglottis distance

    Time frame: up to 1 hour

    by ultrasound

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 17, 2020
Registry last updated
Sep 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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