Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-03-13 @ 3:21 PM
Study NCT ID:
NCT06349005
Status:
COMPLETED
Last Update Posted:
2025-05-29
First Post:
2024-02-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laryngoscopy and Coronary Artery Bypass Graft Surgery
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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-01-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-28', 'studyFirstSubmitDate': '2024-02-26', 'studyFirstSubmitQcDate': '2024-03-31', 'lastUpdatePostDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemodynamic response', 'timeFrame': 'Change from baseline Systolic or Diastolic or mean Blood Pressure at 10 minutes', 'description': 'Change from baseline invasive blood pressure'}, {'measure': 'Hemodynamic response', 'timeFrame': 'Change from baseline heart rate at 10 minutes', 'description': 'Change from baseline heart rate'}], 'secondaryOutcomes': [{'measure': 'Intubation time', 'timeFrame': '180 seconds', 'description': 'The duration from when the laryngoscope passes through the teeth until it is withdrawn back to the teeth will be measured.'}, {'measure': 'Visualization of the glottis', 'timeFrame': '180 seconds', 'description': 'According to Cormack Lehane classification four grades (1-4). The higher the grade, the higher the likelihood of difficult intubation.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Videolaryngoscopy']}, 'descriptionModule': {'briefSummary': 'In this prospective, randomized, controlled trial, the purpose is to compare Macintosh laryngoscope, EzVision® video laryngoscope, McGrath® video laryngoscope and Storz® video laryngoscope in terms of hemodynamic response associated with intubation in adult patients undergoing Coronary Artery Bypass Surgery (CABG).', 'detailedDescription': 'During endotracheal intubation, laryngoscopy can significantly affect hemodynamic responses, including tachycardia and elevated blood pressure, which may be particularly detrimental to individuals with cardiovascular conditions. Various studies have explored the hemodynamic reactions associated with laryngeal stimulation through different intubation devices. Researchers hypothesize that endotracheal intubation using video laryngoscopy will elicit a reduced hemodynamic response compared to traditional (Macintosh) laryngoscopy. In this prospective and randomized clinical study, the purpose is to compare the Macintosh laryngoscope, EzVision® video laryngoscope, McGrath® video laryngoscope and Storz® video laryngoscope concerning haemodynamic response associated with intubation in adult patients undergoing Coronary Artery Bypass Surgery (CABG).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age range between 18 and 75 years.\n* Scheduled for elective coronary artery bypass surgery.\n* Classified under American Society of Anesthesiologists (ASA) physical status II-III.\n* Patients with no history of difficult intubation or associated risk factors.\n\nExclusion Criteria:\n\n* Emergency case\n* Predicted difficult airways\n* Body mass index \\> 35 kilograms per meter squared\n* Baseline hemodynamic instability'}, 'identificationModule': {'nctId': 'NCT06349005', 'acronym': 'VL', 'briefTitle': 'Laryngoscopy and Coronary Artery Bypass Graft Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Konya Meram State Hospital'}, 'officialTitle': 'Hemodynamic Response to Various Laryngoscopes During Tracheal Intubation in CABG Patients', 'orgStudyIdInfo': {'id': '111'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group Storz VL', 'description': 'Patients will undergo intubation with the Storz Videolaryngoscope®, during which their hemodynamic responses will be documented.', 'interventionNames': ['Other: Tracheal intubation using Storz VL']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group MacGrath VL', 'description': 'Patients will undergo intubation with the McGrath Videolaryngoscope®, during which their hemodynamic responses will be documented.', 'interventionNames': ['Other: Tracheal intubation using MacGrath VL']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group EzVision VL', 'description': 'Patients will undergo intubation with the EzVision Videolaryngoscope®, during which their hemodynamic responses will be documented.', 'interventionNames': ['Other: Tracheal intubation using EzVision VL']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group Traditional', 'description': 'Patients will undergo intubation with the traditional (Macintosh) laryngoscopy, during which their hemodynamic responses will be documented.', 'interventionNames': ['Other: Tracheal intubation using Macintosh laryngoscopy']}], 'interventions': [{'name': 'Tracheal intubation using Storz VL', 'type': 'OTHER', 'description': 'Video-assisted intubation technique using Storz VL', 'armGroupLabels': ['Group Storz VL']}, {'name': 'Tracheal intubation using Macintosh laryngoscopy', 'type': 'OTHER', 'description': 'Traditional intubation technique using Macintosh laryngoscopy', 'armGroupLabels': ['Group Traditional']}, {'name': 'Tracheal intubation using MacGrath VL', 'type': 'OTHER', 'description': 'Video-assisted intubation technique using MacGrath VL', 'armGroupLabels': ['Group MacGrath VL']}, {'name': 'Tracheal intubation using EzVision VL', 'type': 'OTHER', 'description': 'Video-assisted intubation technique using EzVision VL', 'armGroupLabels': ['Group EzVision VL']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Konya', 'country': 'Turkey (Türkiye)', 'facility': 'Konya City Hospital', 'geoPoint': {'lat': 37.87135, 'lon': 32.48464}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Konya Meram State Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr', 'investigatorFullName': 'Betul Kozanhan', 'investigatorAffiliation': 'Konya Meram State Hospital'}}}}