Clinical trial NCT02952560: A Comparative Study of Ultrasound Versus CT Measurement of Tongue and Oral Cavity Size
Official title: A Comparative Study of Ultrasound Versus CT Measurement of Tongue and Oral Cavity Size: Validation of Sonographic Technique
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ultrasound Airway Imaging in Determining the Oral Cavity and Tongue Size
Keywords: Ultrasound
Computed Tomography
Oral cavity size
The Mallampati classification
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2016-11-02
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


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

Primary outcomes:
measure: 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.
timeFrame: 2012-2013
measure: Validity of ultrasound measurement of the two airway parameters (tongue thickness and height of oral cavity) against CT measurements of the same parameters.
timeFrame: 2012-2013
Secondary outcomes:
measure: Reproducibility of the ultrasound measurements
timeFrame: 2012-2013
measure: Correlating ultrasound measured values with Mallampati scores
timeFrame: 2012-2013
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: University of Toronto
name: Vincent W.S Chan, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Savva D. Prediction of difficult tracheal intubation. Br J Anaesth. 1994 Aug;73(2):149-53. doi: 10.1093/bja/73.2.149.
citation: Werner SL, Smith CE, Goldstein JR, Jones RA, Cydulka RK. Pilot study to evaluate the accuracy of ultrasonography in confirming endotracheal tube placement. Ann Emerg Med. 2007 Jan;49(1):75-80. doi: 10.1016/j.annemergmed.2006.07.004. Epub 2006 Oct 2.
citation: Lakhal K, Delplace X, Cottier JP, Tranquart F, Sauvagnac X, Mercier C, Fusciardi J, Laffon M. The feasibility of ultrasound to assess subglottic diameter. Anesth Analg. 2007 Mar;104(3):611-4. doi: 10.1213/01.ane.0000260136.53694.fe.
citation: Tsui BC, Hui CM. Sublingual airway ultrasound imaging. Can J Anaesth. 2008 Nov;55(11):790-1. doi: 10.1007/BF03016357. No abstract available.