Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-02-21 @ 4:11 AM
Study NCT ID:
NCT03764904
Status:
UNKNOWN
Last Update Posted:
2018-12-06
First Post:
2018-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Airway Ultrasound as a Predictor for Postextubation Stridor in Anterior Cervical Spine Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2019-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-12-04', 'studyFirstSubmitDate': '2018-12-04', 'studyFirstSubmitQcDate': '2018-12-04', 'lastUpdatePostDateStruct': {'date': '2018-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the correlation between the post procedural laryngeal air-column width difference [LACWD] as obtained by laryngeal US with occurrence of postextubation stridor', 'timeFrame': 'First 6 hours postoperatively', 'description': 'At the end of operation, laryngeal air column width \\[which is defined as the width of air between the vocal cords as demonstrated by US\\] will be obtained while the tube cuff is inflated then while it is deflated for three consecutive respiratory cycles after gentle suction of oropharyngeal airway. The laryngeal air-column width difference \\[LACWD\\] (the difference between width at balloon-cuff deflation and at balloon-cuff inflation) will be obtained and the average value will be recorded.\n\nPatient will be considered ready for extubation after performance of the cuff-leak test as \\[the volume of reduced cuff leak test is more than 110 ml\\] then reversal of neuromuscular blockade will be done. They tube will be removed when the patients can open their eyes on verbal commands and the T4/T1 ratio is 90% or more.\n\nAfter transferal of patients ICU where they will be observed for occurrence of postextubation stridor in the first 6 hour postoperatively.'}], 'secondaryOutcomes': [{'measure': 'Incidence of other airway complication as hematoma', 'timeFrame': 'Intraoperative pre-extubation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postextubation Stridor']}, 'descriptionModule': {'briefSummary': 'literature on use of the ultrasound (US) in extubation decisions in cervical spine surgery is scarce.The aim of this study will be to evaluate the utility of US as an aid for decision making for extubation in elective cervical spine surgery (anterior approach) operations and as a predictor for postextubation stridor in these operations'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Thirty patients aged 18-60 years ASA Ⅰ and Ⅱ of both genders who are scheduled for elective anterior cervical surgery under general anesthesia in supine position for the first time will be enrolled in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* surgeries associated with either exposure of more than three vertebral bodies,\n* exposures involving the C2-C4 levels,\n* blood loss exceeding 300 mL\n* surgical time of more than five hours,\n\nExclusion Criteria:\n\n* laryngotracheobronchial pathology,\n* severe cardiorespiratory disease,\n* admitted for redo-surgery\n* intubated prior to operation\n* Patient with anesthetic risk factors include Mallampati 3 or 4 and multiple intubation attempts'}, 'identificationModule': {'nctId': 'NCT03764904', 'briefTitle': 'Airway Ultrasound as a Predictor for Postextubation Stridor in Anterior Cervical Spine Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Airway Ultrasound as a Predictor for Postextubation Stridor in Cervical Spine Surgery [Anterior Approach]: Prospective Observational Study', 'orgStudyIdInfo': {'id': 'FMASU R 68 /2018'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Airway Ultrasound', 'type': 'RADIATION', 'description': 'Laryngeal US will be performed with a 12 megahertz (MHz) linear probe attached to the ultrasound device. With the probe placed transversely on the midline of the anterior neck over the cricothyroid membrane.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11591', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain Shams University hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Anesthesia', 'investigatorFullName': 'Marwa Ahmed Khairy Elbeialy', 'investigatorAffiliation': 'Ain Shams University'}}}}