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Clinical Trials/NCT02952560
NCT02952560
Completed
Not Applicable

A Comparative Study of Ultrasound Versus CT Measurement of Tongue and Oral Cavity Size: Validation of Sonographic Technique

University Health Network, Toronto1 site in 1 country24 target enrollmentMarch 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ultrasound Airway Imaging in Determining the Oral Cavity and Tongue Size
Sponsor
University Health Network, Toronto
Enrollment
24
Locations
1
Primary Endpoint
Validity of ultrasound measurement of the two airway parameters (tongue thickness and height of oral cavity) against CT measurements of the same parameters.
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

Difficulty in managing the airway is the single most important cause of major anesthesia-related morbidity and mortality. The currently used clinical method of predicting airway difficulty used by anesthetists is limited and not very highly sensitive or specific. Any additional bedside method that increases its specificity and sensitivity would be valuable. This project is designed to study and measure the tongue thickness and oral cavity height by using an ultrasound scan and comparing them with the same measurements obtained by CT scan. These will also be compared to a more complicated measurements used in previous studies to investigate any correlation with the currently used clinical methods. This information will help us decide if ultrasound may help Anesthesiologists assess difficulties in airway management in a more accurate, precise and reliable simpler method.

Registry
clinicaltrials.gov
Start Date
March 2012
End Date
June 2017
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age between 18 to 80 Years
  • Gender: Both males and females are eligible for the study
  • ASA I-III
  • Scheduled for CT-scan of the head and neck as part of medical investigation (for test validation part)

Exclusion Criteria

  • Volunteer/ patient refusal
  • Language Barrier
  • Known oropharyngeal, laryngeal or head and neck disease or cancers
  • Multiple amalgam fillings of the teeth
  • Past history of oral or head and neck surgical procedures
  • Past history of burns or radiotherapy of the head and neck region
  • Presence of any scars, sinuses, infection, swelling, cysts in the head and neck region

Outcomes

Primary Outcomes

Validity of ultrasound measurement of the two airway parameters (tongue thickness and height of oral cavity) against CT measurements of the same parameters.

Time Frame: 2012-2013

Validity of the assumption that ratio of "tongue thickness/oral cavity height" is a good estimate of the ratio "tongue volume/oral cavity volume" as measured by CT scan.

Time Frame: 2012-2013

Secondary Outcomes

  • Reproducibility of the ultrasound measurements(2012-2013)
  • Correlating ultrasound measured values with Mallampati scores(2012-2013)

Study Sites (1)

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