Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-01-03 @ 7:27 PM
Study NCT ID:
NCT00799357
Status:
COMPLETED
Last Update Posted:
2023-08-30
First Post:
2008-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Utility of Bedside Ultrasound in the Prediction of Difficult Airway
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 162}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2009-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-28', 'studyFirstSubmitDate': '2008-11-26', 'studyFirstSubmitQcDate': '2008-11-26', 'lastUpdatePostDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-11-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Predictors of difficult laryngoscopy', 'timeFrame': 'one day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ultrasound'], 'conditions': ['Laryngoscopy']}, 'referencesModule': {'references': [{'pmid': '17323663', 'type': 'RESULT', 'citation': 'Komatsu R, Sengupta P, Wadhwa A, Akca O, Sessler DI, Ezri T, Lenhardt R. Ultrasound quantification of anterior soft tissue thickness fails to predict difficult laryngoscopy in obese patients. Anaesth Intensive Care. 2007 Feb;35(1):32-7. doi: 10.1177/0310057X0703500104.'}, {'pmid': '14616599', 'type': 'RESULT', 'citation': 'Ezri T, Gewurtz G, Sessler DI, Medalion B, Szmuk P, Hagberg C, Susmallian S. Prediction of difficult laryngoscopy in obese patients by ultrasound quantification of anterior neck soft tissue. Anaesthesia. 2003 Nov;58(11):1111-4. doi: 10.1046/j.1365-2044.2003.03412.x.'}, {'pmid': '11388555', 'type': 'RESULT', 'citation': 'Chou HC, Wu TL. Large hypopharyngeal tongue: a shared anatomic abnormality for difficult mask ventilation, difficult intubation, and obstructive sleep apnea? Anesthesiology. 2001 May;94(5):936-7. doi: 10.1097/00000542-200105000-00043. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the utility of bedside ultrasound to predict difficult airway in patients requiring emergency intubation.', 'detailedDescription': 'A variety of pre-intubation clinical screening tests have been advocated to predict difficult laryngoscopy, but their usefulness is limited in emergency department, intensive care unit, pre-hospital and combat settings. Patients in these settings are often confused, lethargic, obtunded, uncooperative and common screening tests for difficult laryngoscopy cannot be applied in a large number of emergency intubations. In the recent past, there has been growing interest in upper airway ultrasound. The purpose of this study is to assess the utility of bedside ultrasound to predict difficult airway in patients requiring emergency intubation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Pre-op patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for any surgery under general anesthesia with endotracheal intubation\n\nExclusion Criteria:\n\n* Upper airway pathologies (facial fractures, tumours, etc)\n* Cervical spine fractures\n* Tracheostomy tube\n* unable to give consent'}, 'identificationModule': {'nctId': 'NCT00799357', 'briefTitle': 'Utility of Bedside Ultrasound in the Prediction of Difficult Airway', 'organization': {'class': 'OTHER', 'fullName': 'University of Nebraska'}, 'officialTitle': 'Utility of Bedside Ultrasound in the Prediction of Difficult Airway', 'orgStudyIdInfo': {'id': '0526-08-EP'}}, 'contactsLocationsModule': {'locations': [{'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}], 'overallOfficials': [{'name': 'Srikar R Adhikari', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nebraska'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nebraska', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Association for Medical Ultrasound', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}