Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-27 @ 6:47 AM
Study NCT ID:
NCT02952560
Status:
COMPLETED
Last Update Posted:
2017-12-06
First Post:
2016-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparative Study of Ultrasound Versus CT Measurement of Tongue and Oral Cavity Size
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019220', 'term': 'High-Energy Shock Waves'}], 'ancestors': [{'id': 'D000069453', 'term': 'Ultrasonic Waves'}, {'id': 'D013016', 'term': 'Sound'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-04', 'studyFirstSubmitDate': '2016-10-31', 'studyFirstSubmitQcDate': '2016-10-31', 'lastUpdatePostDateStruct': {'date': '2017-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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'}], 'secondaryOutcomes': [{'measure': 'Reproducibility of the ultrasound measurements', 'timeFrame': '2012-2013'}, {'measure': 'Correlating ultrasound measured values with Mallampati scores', 'timeFrame': '2012-2013'}]}, 'conditionsModule': {'keywords': ['Ultrasound', 'Computed Tomography', 'Oral cavity size', 'The Mallampati classification'], 'conditions': ['Ultrasound Airway Imaging in Determining the Oral Cavity and Tongue Size']}, 'referencesModule': {'references': [{'pmid': '7917726', 'type': 'BACKGROUND', 'citation': 'Savva D. Prediction of difficult tracheal intubation. Br J Anaesth. 1994 Aug;73(2):149-53. doi: 10.1093/bja/73.2.149.'}, {'pmid': '17014927', 'type': 'BACKGROUND', '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.'}, {'pmid': '17312218', 'type': 'BACKGROUND', '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.'}, {'pmid': '19138924', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 to 80 Years\n* Gender: Both males and females are eligible for the study\n* ASA I-III\n* Scheduled for CT-scan of the head and neck as part of medical investigation (for test validation part)\n\nExclusion Criteria:\n\n* Volunteer/ patient refusal\n* Language Barrier\n* Known oropharyngeal, laryngeal or head and neck disease or cancers\n* Multiple amalgam fillings of the teeth\n* Past history of oral or head and neck surgical procedures\n* Past history of burns or radiotherapy of the head and neck region\n* Presence of any scars, sinuses, infection, swelling, cysts in the head and neck region'}, 'identificationModule': {'nctId': 'NCT02952560', 'briefTitle': 'A Comparative Study of Ultrasound Versus CT Measurement of Tongue and Oral Cavity Size', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'A Comparative Study of Ultrasound Versus CT Measurement of Tongue and Oral Cavity Size: Validation of Sonographic Technique', 'orgStudyIdInfo': {'id': '11-0791-AE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'High resolution CT Scan of the head and neck', 'description': '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.', 'interventionNames': ['Other: Ultrasound scan']}], 'interventions': [{'name': 'Ultrasound scan', 'type': 'OTHER', 'description': "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.", 'armGroupLabels': ['High resolution CT Scan of the head and neck']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Vincent W.S Chan, MD, FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Toronto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}