Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-27 @ 7:12 AM
Study NCT ID:
NCT06011967
Status:
COMPLETED
Last Update Posted:
2024-11-19
First Post:
2023-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intubation with Different Angled Intubation Tubes Using C-macr D Blade Videolaringoscope;
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010612', 'term': 'Pharyngitis'}, {'id': 'D006685', 'term': 'Hoarseness'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D014832', 'term': 'Voice Disorders'}, {'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'In this study we compared the ease of intubation, time needed for intubation, subglottic damage, postoperaitve sore throat, hoarseness and hemodynamic response to orotracheal intubation using three different angled intubation stylets with C-MAC R videolaryngoscope D- blade.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2022-06-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-14', 'studyFirstSubmitDate': '2023-08-11', 'studyFirstSubmitQcDate': '2023-08-21', 'lastUpdatePostDateStruct': {'date': '2024-11-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sore throat', 'timeFrame': '30 minutes, 4 hour, 12 hour, 24 hour', 'description': 'For evaluation of sore throat, the patients were asked whether they had any throat pain. The severity of sore throat was graded as follows: 1: no sore throat, 2: minimal, 3: moderate, 4: severe'}], 'secondaryOutcomes': [{'measure': 'Ease of intubation', 'timeFrame': '2 minutes', 'description': 'For evaluation of the ease of intubation modified intubation difficulty score was used.'}, {'measure': 'Subglottic damage', 'timeFrame': '2 hours', 'description': 'For evaluation of subglottic damage 4-point scaled subglottic damage score was used. grade 0, normal; grade 1, mucosal hyperaemia and oedema and/or slight submucosal haematoma; grade 2, moderately submucosal haematoma; grade 3, mucosal laceration and/or mucosal bleeding'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Videolaryngoscope,', 'Intubation', 'C-MAC R Videolaryngoscope,', 'D- Blade', 'Subglottic damage', 'Postoperative sore throat,', 'Hoarsness'], 'conditions': ['Intubation; Difficult or Failed', 'Sore-throat', 'Hoarseness']}, 'descriptionModule': {'briefSummary': 'In this study we compared post-operative sore throat, ease and time of intubation, hoarseness, subglottic damage and hemodynamic changes to orotracheal intubation using three different intubation stylets with C-MAC R videolaryngoscope D- blade.', 'detailedDescription': 'In this study we compared the ease of intubation, time needed for intubation, subglottic damage, postoperaitve sore throat, hoarseness and hemodynamic response to orotracheal intubation using three different intubation stylets with C-MAC R videolaryngoscope D- blade. After the approval of the Ethics Committee, patients were randomized into three groups with closed envelope technique. In Group A endotracheal tube (ETT) is shaped into an angel of 90 degrees, in Group B 80 degrees and in Group C 60 degrees with three different stylets. Laryngoscopy was performed using D-Blade in all 3 groups. Heart rate and blood pressure before and after intubation, time from the entrance of the laryngoscope into the mouth to the passage of the vocal cords, time from the appearance of the cords to intubation, Cormack-Lehane (C-L) classification were recorded. Subglottic damage was examined with fiberoptic bronchoscope. Patients were evaluated regarding postoperative sore throat and hoarsness at 30 minutes, 4, 12, 24 hours postoperatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA score I-II\n* Elective operations\n* Supine pozition\n* 18-65 years\n* No history of surgery in the last 6 months\n* No history of airway related surgery\n* No anticipated difficult airway\n\nExclusion Criteria:\n\n* Abdomen, thorax, head-neck surgeries\n* Smoker\n* Chronic alcohol abuse\n* Occupational inhaler agent exposure\n* Patients with malignancies\n* Patients with a history of radiotheraphy to head-neck region\n* Patients with congenital anomalies at head-neck region\n* Patients with diagnosed abnormalites of head -neck movements\n* Non-cooperatied patients\n* Non-oriented patients'}, 'identificationModule': {'nctId': 'NCT06011967', 'briefTitle': 'Intubation with Different Angled Intubation Tubes Using C-macr D Blade Videolaringoscope;', 'organization': {'class': 'OTHER', 'fullName': 'Yeditepe University'}, 'officialTitle': 'Intubation with Different Angled Intubation Tubes Using C-macr D Blade Videolaringoscope; Evaluation of the Effect on Post-operative Sore Throat, Ease and Time of Intubation, Hoarseness, Subglottic Damage and Hemodynamic Changes : a Prospective Randomized Study', 'orgStudyIdInfo': {'id': 'E-66175679-514.04.01-788907'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A : 90 degree', 'description': 'In this group patients were intubated using a 90 degree angled stylet with C-MAC D- Blade videolaryngoscope', 'interventionNames': ['Other: Intubation using C-MAC D blade videolariyngoscope']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B : 80 degree', 'description': 'In this group patients were intubated using a 80 degree angled stylet with C-MAC D- Blade videolaryngoscope', 'interventionNames': ['Other: Intubation using C-MAC D blade videolariyngoscope']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group C: 60 degree', 'description': 'In this group patients were intubated using a 60 degree angled stylet with C-MAC D- Blade videolaryngoscope', 'interventionNames': ['Other: Intubation using C-MAC D blade videolariyngoscope']}], 'interventions': [{'name': 'Intubation using C-MAC D blade videolariyngoscope', 'type': 'OTHER', 'description': 'all patients were intubated using the C-MAC D-Blade videolaryngoscope but for each group the intubation tubes were angled in different degrees. First group was intubated using the stylet of 60 degrees, second group was intubated using the stylet of 80 degrees and the third group was intubated using the stylet of 90 degrees.', 'armGroupLabels': ['Group A : 90 degree', 'Group B : 80 degree', 'Group C: 60 degree']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Yeditepe University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Alkım Gizem Yılmaz Selimoğlu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yeditepe University'}, {'name': 'Ferdi Menda, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'yYeditepe Universitu'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yeditepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}