Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-24 @ 4:37 PM
Study NCT ID:
NCT03999866
Status:
COMPLETED
Last Update Posted:
2019-10-23
First Post:
2019-06-25
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Preoperative Assessment of Difficult Laryngoscopy Using Different Videolaryngoscopes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'We used these 4 video laryngoscopes ( c-mac, d-blade, macgrath mac x-blade and airtraq) on the same patient.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-21', 'studyFirstSubmitDate': '2019-06-25', 'studyFirstSubmitQcDate': '2019-06-26', 'lastUpdatePostDateStruct': {'date': '2019-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'satisfaction of the instructor: visual analogy scale', 'timeFrame': '2 minutes', 'description': 'visual analogy scale of the satisfaction'}], 'secondaryOutcomes': [{'measure': 'satisfaction of the patient: visual analogy scale', 'timeFrame': '2 minutes', 'description': 'visual analogy scale of the satisfaction'}, {'measure': 'duration view', 'timeFrame': '10 seconds', 'description': 'time frame from the device enter the oral cavity till the vocal cords visualized'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['airtraq', 'c-mac', 'd-blade', 'mcgarth mac x-blade', 'prediction', 'difficult airway'], 'conditions': ['Assessment', 'Difficult Airway Intubation', 'Preoperative']}, 'descriptionModule': {'briefSummary': 'preoperative assessment of difficult airways are the subject of debate. Now, measuring the thyromental distance or evaluating the mallampati score, mandible protrusion or body mass index still not 100% specifically say anything. We compare 4 different video laryngoscopes for preoperative assessment of difficult laryngoscopy.', 'detailedDescription': 'preoperative assessment of difficult airways are the subject of debate. Now, measuring the thyromental distance or evaluating the mallampati score, mandible protrusion or body mass index still not 100% specifically say anything. all patients were pre oxygenated with 100% oxygen with nasal canulla during the whole procedure. We administered 0.07 mgr/kg remifentanil for minimum 3 minutes and continue this infusion during the procedure. The patients airway topicalized by 10% lidocaine spray. We enroll 20 patients undergoing elective surgery.\n\nWe compare 4 different video laryngoscopes for preoperative assessment of difficult laryngoscopy in the same patient. We evaluate the patient and the instructors satisfaction with the visual analogy scale and the visualization time. Demographic vary,ables and the airway characteristics of patients. We assess the cormack lehane view of these videolaryngoscopes with or without cricoid pressure. and the occurrence of gag reflex as well.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:- \\> 18 years or \\<60 years of age,\n\n* body mass index \\< 30\n* no difficult airway history or predictor,\n* no respiratory tract infections for ten days,\n\nExclusion Criteria: BMI \\> 35, \\< 18 or \\> 60 years of age, expected difficult airway, pregnant\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03999866', 'briefTitle': 'Preoperative Assessment of Difficult Laryngoscopy Using Different Videolaryngoscopes', 'organization': {'class': 'OTHER', 'fullName': 'Kocaeli University'}, 'officialTitle': 'Awake Airway Assessment With Video Laryngoscopes', 'orgStudyIdInfo': {'id': 'KİA 2019/18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'satisfaction of instructor', 'description': 'visual analogy scale of the satisfaction of the instructor was recorded', 'interventionNames': ['Device: airtraq', 'Device: mcgrath mac x-blade', 'Device: storz c-mac', 'Device: storz d-blade']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'satisfaction of the patient', 'description': 'visual analogy scale of the satisfaction of the patient was recorded', 'interventionNames': ['Device: airtraq', 'Device: mcgrath mac x-blade', 'Device: storz c-mac', 'Device: storz d-blade']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'duration of view', 'description': 'duration of the visualization the vocal cords was recorded', 'interventionNames': ['Device: airtraq', 'Device: mcgrath mac x-blade', 'Device: storz c-mac', 'Device: storz d-blade']}], 'interventions': [{'name': 'airtraq', 'type': 'DEVICE', 'otherNames': ['videolaryngoscope'], 'description': 'airtraq videolaryngoscope', 'armGroupLabels': ['duration of view', 'satisfaction of instructor', 'satisfaction of the patient']}, {'name': 'mcgrath mac x-blade', 'type': 'DEVICE', 'otherNames': ['videolaryngoscope'], 'description': 'mcgarth mac videolaryngoscope', 'armGroupLabels': ['duration of view', 'satisfaction of instructor', 'satisfaction of the patient']}, {'name': 'storz c-mac', 'type': 'DEVICE', 'otherNames': ['videolaryngoscope'], 'description': 'storz c-mac videolaryngoscope', 'armGroupLabels': ['duration of view', 'satisfaction of instructor', 'satisfaction of the patient']}, {'name': 'storz d-blade', 'type': 'DEVICE', 'otherNames': ['videolaryngoscope'], 'description': 'storz d-blade video laryngoscope', 'armGroupLabels': ['duration of view', 'satisfaction of instructor', 'satisfaction of the patient']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41900', 'city': 'Kocaeli', 'country': 'Turkey (Türkiye)', 'facility': 'Kocaeli University School of Medicine', 'geoPoint': {'lat': 39.62497, 'lon': 27.51145}}], 'overallOfficials': [{'name': 'Zehra I Arslan', 'role': 'STUDY_CHAIR', 'affiliation': 'Associate Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kocaeli University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Zehra Ipek ARSLAN', 'investigatorAffiliation': 'Kocaeli University'}}}}