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

NCT ID: NCT02952560

Last Updated: 2017-12-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 24 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2017-06-30

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.

Conditions

Ultrasound Airway Imaging in Determining the Oral Cavity and Tongue Size

Keywords

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Ultrasound scan

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vincent W.S Chan, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Locations

Princess Margaret Hospital

Toronto, Ontario, Canada

Countries

Canada

References

Savva D. Prediction of difficult tracheal intubation. Br J Anaesth. 1994 Aug;73(2):149-53. doi: 10.1093/bja/73.2.149.

Reference Type: BACKGROUND

PMID: 7917726 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17014927 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17312218 (View on PubMed)

Tsui BC, Hui CM. Sublingual airway ultrasound imaging. Can J Anaesth. 2008 Nov;55(11):790-1. doi: 10.1007/BF03016357. No abstract available.

Reference Type: BACKGROUND

PMID: 19138924 (View on PubMed)

Other Identifiers

11-0791-AE

Identifier Type: -

Identifier Source: org_study_id