Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2026-02-21 @ 6:45 PM
Study NCT ID:
NCT02362568
Status:
COMPLETED
Last Update Posted:
2016-08-31
First Post:
2014-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Interest on Cervical Ultrasound Exploration for Association With Difficult Intubation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 462}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-30', 'studyFirstSubmitDate': '2014-01-28', 'studyFirstSubmitQcDate': '2015-02-09', 'lastUpdatePostDateStruct': {'date': '2016-08-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensibility, Specificity, predictive positive and negative values of US cervical measures relationship between the hyoid bone and thyroid cartilage with difficult intubation', 'timeFrame': 'Day 1', 'description': 'The measure of the length between the hyoid bone and the skin and between the thyroid cartilage and the skin will be measured using an ultrasound cervical exploration in all patients admitted in the postoperative room after planned surgery performed under general anesthesia.'}], 'secondaryOutcomes': [{'measure': 'Sensibility, specificity and predictive positive and negative values of validated clinical criteria for difficult intubation', 'timeFrame': 'Day 1', 'description': 'The collect of usual clinical criteria of difficult intubation in postoperative room of patients who undergo a general anesthesia for a surgery'}, {'measure': 'Mortality and morbidity of difficult intubation', 'timeFrame': 'Day 1', 'description': 'Collect any complications (hypoxia, hypotension, tooth breakage) assigned to a difficult intubation during general anesthesia for surgery.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Intubation; Difficult'], 'conditions': ['Intubation; Difficult']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if cervical ultrasound exploration can predict difficult intubation better than main validated clinical criteria.', 'detailedDescription': 'The purpose of this study is to determine if cervical ultrasound exploration can predict difficult intubation better than main validated clinical criteria in general surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age over 18\n* patient consent\n\nExclusion Criteria:\n\n* patient nonconsent\n* age under 18\n* cervical surgery'}, 'identificationModule': {'nctId': 'NCT02362568', 'acronym': 'TUBECHO', 'briefTitle': 'Study of Interest on Cervical Ultrasound Exploration for Association With Difficult Intubation', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Besancon'}, 'officialTitle': 'Human Study of Interest on Cervical Ultrasound Exploration for Association With Criteria of Difficult Intubation in General Surgery', 'orgStudyIdInfo': {'id': 'P/2013/181'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Cervical ultrasound exploration', 'description': 'A cervical ultrasound exploration will be performed in all patients admitted for a planned surgery performed under general anesthesia during the stay in the postoperative room.', 'interventionNames': ['Procedure: Ultrasound cervical exploration']}], 'interventions': [{'name': 'Ultrasound cervical exploration', 'type': 'PROCEDURE', 'description': 'The cervical ultrasound exploration will consist in the ultrasound measurement of the length between the hyoid bone and the skin and the length between the thyroid cartilage and the skin. The ultrasound cervical exploration will be performed in all patients admitted in the postoperative room after a planned surgery performed under general anesthesia.', 'armGroupLabels': ['Cervical ultrasound exploration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25000', 'city': 'Besançon', 'state': 'Franche Comte', 'country': 'France', 'facility': 'CHRU de Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '25000', 'city': 'Besançon', 'country': 'France', 'facility': 'CHU Besancon Minjoz', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}], 'overallOfficials': [{'name': 'Boinette Romain, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Besancon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}