Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-25 @ 9:26 PM
Study NCT ID:
NCT04212156
Status:
COMPLETED
Last Update Posted:
2021-05-17
First Post:
2019-12-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Thyromental Height Test (TMHT) as a Predictor of Difficult Airway in Obese Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-14', 'studyFirstSubmitDate': '2019-12-23', 'studyFirstSubmitQcDate': '2019-12-24', 'lastUpdatePostDateStruct': {'date': '2021-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TMHT', 'timeFrame': 'before induction of general anesthesia', 'description': 'Validity of TMHT for prediction of difficult airway in obese patient undergoing general anesthesia'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Difficult Airway Intubation']}, 'descriptionModule': {'briefSummary': 'Difficult airway management is a major concern for anesthetists and contributes to perioperative morbidity and mortality. The incidence of difficult intubation in the obese population with a BMI of greater than 30 has been reported to be 15.8%. Thyromental height test (TMHT) is a new bedside test for difficult airway, it is a measure of the height between the anterior borders of the mentum and thyroid cartilage. TMHT can act as a surrogate for amount of mandibular protrusion; dimensions of submandibular space; and anterior position of the larynx. It appears promising as a single anatomical measure to predict the risk of difficult laryngoscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients of both sex, aged between 18-60 years old, ASA physical status II\\& III with BMI \\> 30 Kg/m2 who will undergo elective surgical procedures under general anesthesia using endotracheal intubation using conventional laryngoscopy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged between 18-60 years old, ASA physical status II\\& III with BMI \\> 30 Kg/m2 who will undergo elective surgical procedures under general anesthesia using endotracheal intubation with conventional laryngoscopy\n\nExclusion Criteria:\n\n* Patients with neuromuscular disorders, craniofacial abnormalities, abnormal dentition, uncooperative, who need awake intubation and patients who undergoing emergency operations will be excluded'}, 'identificationModule': {'nctId': 'NCT04212156', 'briefTitle': 'Thyromental Height Test (TMHT) as a Predictor of Difficult Airway in Obese Patients', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Validity of Thyromental Height Test (TMHT) as an Objective Predictor of Difficult Airway in Obese Patients: a Prospective Observational Cohort Study', 'orgStudyIdInfo': {'id': 'Ms-266-2019'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TMH test', 'description': 'Patient will be asked to lay supine while the head and neck maintained in a neutral position using a pillow under the head. By using digital depth gauge, the TMH will be measured from the anterior border of the thyroid cartilage directly on the thyroid notch till the anterior border of the mentum'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11562', 'city': 'Maadi', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': 'Abeer Ahmed', 'geoPoint': {'lat': 29.95958, 'lon': 31.25924}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Anesthesia, SICU & pain management. Kasralainy Faculty of medicine', 'investigatorFullName': 'Abeer Ahmed, MD', 'investigatorAffiliation': 'Cairo University'}}}}