Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-02-24 @ 5:02 PM
Study NCT ID:
NCT02805569
Status:
COMPLETED
Last Update Posted:
2018-04-03
First Post:
2016-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Intubation Conditions of the Articulating Stylet and Intubating Stylet Guided Videolaryngoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-01', 'studyFirstSubmitDate': '2016-06-13', 'studyFirstSubmitQcDate': '2016-06-15', 'lastUpdatePostDateStruct': {'date': '2018-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intibation time', 'timeFrame': 'Through intubation completion, an avarage of 5 minutes', 'description': 'Total intubation time (second)'}], 'secondaryOutcomes': [{'measure': 'tracheal intubation attempts', 'timeFrame': 'Through intubation completion, an avarage of 5 minutes', 'description': 'number of intubation attempts'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['videolaryngoscope', 'intubation stylet', 'articulating stylet', 'difficult airway'], 'conditions': ['Difficult Intubation']}, 'referencesModule': {'references': [{'pmid': '9416711', 'type': 'RESULT', 'citation': 'Adnet F, Borron SW, Racine SX, Clemessy JL, Fournier JL, Plaisance P, Lapandry C. The intubation difficulty scale (IDS): proposal and evaluation of a new score characterizing the complexity of endotracheal intubation. Anesthesiology. 1997 Dec;87(6):1290-7. doi: 10.1097/00000542-199712000-00005.'}, {'pmid': '26133898', 'type': 'RESULT', 'citation': 'Suppan L, Tramer MR, Niquille M, Grosgurin O, Marti C. Alternative intubation techniques vs Macintosh laryngoscopy in patients with cervical spine immobilization: systematic review and meta-analysis of randomized controlled trials. Br J Anaesth. 2016 Jan;116(1):27-36. doi: 10.1093/bja/aev205. Epub 2015 Jun 30.'}]}, 'descriptionModule': {'briefSummary': 'Indirect videolaryngoscopes provide an improved view of the glottis. Unfortunately enhanced video blade angulation leads to difficulty in passage of the endotracheal tube (ETT) towards the larynx around the steep blade angulation despite adequate visualization of the glottis. Pre-shaping the ETT with the rigit malleable stylet is recommended. The investigators hypothesized that using articulating stylet (AS) would enhance first attempt intubation, shorten the intubation time, reduce the possibility of the soft tissue trauma compared to conventional intubation stylet (IS) in patients with difficult airway .', 'detailedDescription': 'Patients with known airway difficulty (anticipated difficult airway (ADA) score \\>6) will be included to the study.\n\nAll patients will receive general anesthesia for a variety of elective surgical procedure. Tracheal intubation will be performed by senior anesthesiologist. Patients will be intubated using AS-videolaryngoscope (n= 24) or IS-videolaryngoscope (n=24) randomly. Patients demographic details (age 18-65 yr, body mass index, ASA phisical status), ADA scores, Cormack-Lehane scores, intubation difficulty scores, intubation attempts, intubation time, hemodynamic variables, sore throat, anesthesiologists satisfaction will be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA 1-2 physical status (Anticipated difficult airway) ADA scores \\>6 Elective surgery\n\nExclusion Criteria:\n\n* ASA 3-4 physical status Immobilizedcervical spine'}, 'identificationModule': {'nctId': 'NCT02805569', 'briefTitle': 'Comparison of Intubation Conditions of the Articulating Stylet and Intubating Stylet Guided Videolaryngoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Diskapi Teaching and Research Hospital'}, 'officialTitle': 'Comparison of Intubation Conditions of the Articulating Stylet and Intubating Stylet Guided Videolaryngoscopy in Patients With Difficult Airway', 'orgStudyIdInfo': {'id': '27/28'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', 'description': 'articulating stylet', 'interventionNames': ['Device: articulating stylet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group C', 'description': 'conventional stylet', 'interventionNames': ['Device: conventional stylet']}], 'interventions': [{'name': 'articulating stylet', 'type': 'DEVICE', 'description': 'patient who intubated with articulating stylet', 'armGroupLabels': ['Group A']}, {'name': 'conventional stylet', 'type': 'DEVICE', 'description': 'patient who intubated with conventional stylet', 'armGroupLabels': ['group C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06110', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital Ankara, Turkey', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Derya Özkan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital Ankara, Turkey'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Diskapi Teaching and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated profesor', 'investigatorFullName': 'derya özkan', 'investigatorAffiliation': 'Diskapi Teaching and Research Hospital'}}}}