A Comparative Study of Ultrasound Versus CT Measurement of Tongue and Oral Cavity Size

Completed

• Conditions: Ultrasound Airway Imaging in Determining the Oral Cavity and Tongue Size
• Interventions: Other: Ultrasound scan

• Registration Number: NCT02952560
• Lead Sponsor: University Health Network, Toronto

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Status Verified: 2016-10
• Study First Submitted: 2016-10-31
• Study First Submitted QC: 2016-10-31
• Study First Posted: 2016-11-02
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Last Update Submitted: 2017-12-04
• Last Update Posted: 2017-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
High resolution CT Scan of the head and neck	Ultrasound scan	Patients scheduled for high resolution computerized tomography (CT scan) of the head and neck as part of their medical investigation of thyroid or laryngeal disorders will be recruited for this study.

Primary Outcome Measures

Name	Time	Method
Validity of ultrasound measurement of the two airway parameters (tongue thickness and height of oral cavity) against CT measurements of the same parameters.	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.	2012-2013

Secondary Outcome Measures

Name	Time	Method
Reproducibility of the ultrasound measurements	2012-2013
Correlating ultrasound measured values with Mallampati scores	2012-2013

Trial Locations

Locations (1)

Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada