Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2025-12-25 @ 7:54 PM
Study NCT ID:
NCT04816435
Status:
UNKNOWN
Last Update Posted:
2021-03-25
First Post:
2021-03-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Airway Ultrasound Assessment in the Prediction of Difficult Airway
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-23', 'studyFirstSubmitDate': '2021-03-23', 'studyFirstSubmitQcDate': '2021-03-23', 'lastUpdatePostDateStruct': {'date': '2021-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pretracheal fat thickness for intubation complexity', 'timeFrame': '5 minutes', 'description': 'The pretracheal fat at the level of the vocal cords will be evaluated with ultrasound, to discern if a certain thickness is related to a difficult laryngoscopic vision (understood as cormack 3 or 4)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Airway Complication of Anesthesia', 'Anesthesia Intubation Complication']}, 'referencesModule': {'references': [{'pmid': '38825182', 'type': 'DERIVED', 'citation': 'Madrid-Vazquez L, Casans-Frances R, Gomez-Rios MA, Cabrera-Sucre ML, Granacher PP, Munoz-Alameda LE. Machine learning models based on ultrasound and physical examination for airway assessment. Rev Esp Anestesiol Reanim (Engl Ed). 2024 Oct;71(8):563-569. doi: 10.1016/j.redare.2024.05.006. Epub 2024 May 31.'}]}, 'descriptionModule': {'briefSummary': 'To assess whether the thickness of pre-tracheal fat, greater than 28 mm, and measured by ultrasound, constitutes a reliable parameter in the prediction of a difficult airway.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients under general anesthesia with orotracheal intubation', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients risk ASA I-IV\n* Non-urgent surgery under general anesthesia with orotracheal intubation\n* Acceptance to participate and grant written consent\n\nExclusion Criteria:\n\n* Urgent surgery\n* Patients with a history of craniocervical pathology (trauma, tumor, malformations)\n* Pregnancy\n* Patient Refusal'}, 'identificationModule': {'nctId': 'NCT04816435', 'briefTitle': 'Airway Ultrasound Assessment in the Prediction of Difficult Airway', 'organization': {'class': 'OTHER', 'fullName': 'Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz'}, 'officialTitle': 'Review of Classical Predictors and Role of Airway Ultrasound in the Prediction of Difficult Airway', 'orgStudyIdInfo': {'id': 'FJD-ECOVAD-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ultrasound test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Ultrasound evaluation of airway'}]}, 'contactsLocationsModule': {'locations': [{'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Fundación Jimenez Díaz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}