Ignite Creation Date:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2025-12-25 @ 10:23 PM
Study NCT ID:
NCT03592758
Status:
COMPLETED
Last Update Posted:
2018-07-19
First Post:
2018-06-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ultrasound in Evaluation of Difficult Airway Management Predictive Indexes
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': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-06-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-17', 'studyFirstSubmitDate': '2018-06-19', 'studyFirstSubmitQcDate': '2018-07-17', 'lastUpdatePostDateStruct': {'date': '2018-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ultrasound assessment', 'timeFrame': 'Ultrasound assessment will be performed 30 minutes before induction of general anaesthesia and the mask ventilation evaluation will be performed 3 minutes after induction with \'\'Han scale".', 'description': 'the association between the ultrasound measurement and the difficulty of mask ventilation measured with the "Han scale". "Han scale" classify mask-ventilation in five grade of progressive difficulty: 0) mask ventilation did not attempt, 1) easy 2) difficult and requiring oral airway 3) very difficult requiring two practitioners 4) unable to mask ventilate.\n\n"Han scale" is the only grading scale available used routinely in anesthesiologic assessment of bag-mask ventilation.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Airway Complication of Anesthesia']}, 'referencesModule': {'references': [{'pmid': '31742568', 'type': 'DERIVED', 'citation': 'Alessandri F, Antenucci G, Piervincenzi E, Buonopane C, Bellucci R, Andreoli C, Alunni Fegatelli D, Ranieri MV, Bilotta F. Ultrasound as a new tool in the assessment of airway difficulties: An observational study. Eur J Anaesthesiol. 2019 Jul;36(7):509-515. doi: 10.1097/EJA.0000000000000989.'}]}, 'descriptionModule': {'briefSummary': 'evaluate the efficacy of the ultrasound approach in predicting difficult mask ventilation in a heterogeneous population of patients undergoing general anesthesia.', 'detailedDescription': 'Preoperative ultrasound of the upper airway and detection of 5 ultrasound measurements:\n\nTrachea-skin distance at the level of the thyroid isthmus; Trachea-skin distance at the jugular level Front commissure-skin distance; Distance from skin to the thyroid membrane Distance between hyoid bone and skin. Comparison of this measurement with HAN-scale for prediction of difficult mask ventilation during general anesthesia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all patient \\> 18 ys undergoing general anesthesia for elective surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- all patient \\> 18years old undergoing general anesthesia for elective surgery\n\nExclusion Criteria:\n\n* Patients with fractures of the bones of the facial mass;\n* Patients with laryngeal tumors\n* Patients previously undergoing demolition of the larynx or neck;\n* Tracheostomized patients;\n* Pregnancy;\n* Inter-incisive distance \\<3 cm;\n* severely limited cervical mobility;\n* Patients who are not given muscle relaxants\n* Patient rejection.'}, 'identificationModule': {'nctId': 'NCT03592758', 'briefTitle': 'Ultrasound in Evaluation of Difficult Airway Management Predictive Indexes', 'organization': {'class': 'OTHER', 'fullName': 'University of Roma La Sapienza'}, 'officialTitle': 'Ultrasound in Evaluation of Difficult Airway Management Predictive Indexes', 'orgStudyIdInfo': {'id': 'UEDAM'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ultrasound assessment', 'description': 'all patient are evaluated by an ultrasound assessment before general anaesthesia'}]}, 'contactsLocationsModule': {'locations': [{'zip': '00100', 'city': 'Roma', 'country': 'Italy', 'facility': 'Policlinico Umberto I - UNiversità Sapienzadi Roma', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Roma La Sapienza', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Francesco Alessandri', 'investigatorAffiliation': 'University of Roma La Sapienza'}}}}