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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02952560
Enrollment
24
Registered
2016-11-02
Start date
2012-03-31
Completion date
2017-06-30
Last updated
2017-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ultrasound Airway Imaging in Determining the Oral Cavity and Tongue Size

Keywords

Ultrasound, Computed Tomography, Oral cavity size, The Mallampati classification

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.

Interventions

OTHERUltrasound scan

Ultrasound scanning examinations will be performed twice (pre-CT scan and post CT-scan). Each examination will be performed by two observers who are blinded to each other's measured values.Patients will be asked to place a small sip of water (20 mL)in their mouth and keep the mouth open during the imaging. A second ultrasound examination of each patient by the two observers will be performed after the CT-scan.

Sponsors

University Health Network, Toronto
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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
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

Secondary

MeasureTime frame
Correlating ultrasound measured values with Mallampati scores2012-2013
Reproducibility of the ultrasound measurements2012-2013

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026