Completed

NCT Number: NCT02952560

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

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.

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Key information

Conditions

Ultrasound Airway Imaging in Determining the Oral Cavity and Tongue Size

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Ultrasound scan

Other

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.

Primary outcomes

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
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

Secondary outcomes

Reproducibility of the ultrasound measurements

Time frame: 2012-2013
Correlating ultrasound measured values with Mallampati scores

Time frame: 2012-2013

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2017
Study completion: 2017
First posted: Nov 2, 2016
Registry last updated: Dec 6, 2017

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.