Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02952560
Recruitment Status : Completed
First Posted : November 2, 2016
Last Update Posted : December 6, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Ultrasound Airway Imaging in Determining the Oral Cavity and Tongue Size Other: Ultrasound scan

Layout table for study information
Study Type : Observational
Actual Enrollment : 24 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: A Comparative Study of Ultrasound Versus CT Measurement of Tongue and Oral Cavity Size: Validation of Sonographic Technique
Actual Study Start Date : March 2012
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
High resolution CT Scan of the head and neck
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.
Other: Ultrasound 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.




Primary Outcome Measures :
  1. 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 ]
  2. 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 Outcome Measures :
  1. Reproducibility of the ultrasound measurements [ Time Frame: 2012-2013 ]
  2. Correlating ultrasound measured values with Mallampati scores [ Time Frame: 2012-2013 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02952560


Locations
Layout table for location information
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Layout table for investigator information
Principal Investigator: Vincent W.S Chan, MD, FRCPC University of Toronto
Publications:
Layout table for additonal information
Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02952560    
Other Study ID Numbers: 11-0791-AE
First Posted: November 2, 2016    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: October 2016
Keywords provided by University Health Network, Toronto:
Ultrasound
Computed Tomography
Oral cavity size
The Mallampati classification