Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2026-03-09 @ 1:46 AM
Study NCT ID:
NCT03657927
Status:
COMPLETED
Last Update Posted:
2019-01-07
First Post:
2018-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison of McGrath MAC Versus C-MAC Videolaryngoscopes in Morbidly Obese Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-06-27', 'size': 347899, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-10-24T08:36', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-04', 'studyFirstSubmitDate': '2018-08-07', 'studyFirstSubmitQcDate': '2018-09-03', 'lastUpdatePostDateStruct': {'date': '2019-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to intubation', 'timeFrame': 'From beginning of holding videolaryngoscope to seeing two meaningful end-tidal carbon dioxide levels up to 3 minutes', 'description': 'Time to intubation was defined as the time from when the anesthesiologist picked up the videolaryngoscope to when the anesthesiologist successfully placed the endotracheal tube through the vocal cords'}], 'secondaryOutcomes': [{'measure': 'Heart Rate', 'timeFrame': 'From beginning of Anesthesia induction to 5th minutes of intubation', 'description': 'Heart Rate'}, {'measure': 'Mean Arterial Pressure', 'timeFrame': 'From beginning of Anesthesia induction to 5th minutes of intubation', 'description': 'Mean Arterial Pressure'}, {'measure': 'Adverse Events', 'timeFrame': 'During the first 24 hour postoperatively', 'description': 'Bleeding in the mouth, edema in the mouth, burst of intubation tube cuff, external laryngeal press, presence of head position change, laryngospasm, hypoxia, hoarseness, throat ache'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Morbidly Obese', 'Difficult Airway Management', 'Videolaryngoscopy'], 'conditions': ['Difficult Intubation', 'Morbid Obesity', 'Videolaryngoscopy']}, 'referencesModule': {'references': [{'pmid': '24643921', 'type': 'BACKGROUND', 'citation': 'Gaszynski T. Clinical experience with the C-Mac videolaryngoscope in morbidly obese patients. Anaesthesiol Intensive Ther. 2014 Jan-Mar;46(1):14-6. doi: 10.5603/AIT.2014.0003.'}, {'pmid': '23121470', 'type': 'BACKGROUND', 'citation': 'Taylor AM, Peck M, Launcelott S, Hung OR, Law JA, MacQuarrie K, McKeen D, George RB, Ngan J. The McGrath(R) Series 5 videolaryngoscope vs the Macintosh laryngoscope: a randomised, controlled trial in patients with a simulated difficult airway. Anaesthesia. 2013 Feb;68(2):142-7. doi: 10.1111/anae.12075. Epub 2012 Nov 5.'}]}, 'descriptionModule': {'briefSummary': 'Along with the technological advances in medicine, videolaryngoscope is the most commonly preferred technique for intubation of expected difficult airway management such as morbidly obese patients. In this prospective controlled clinical study, the purpose is to compare C-MAC videolaryngoscope and McGrath MAC videolaryngoscope in respect to duration of intubation, haemodynamic response, and complications related intubation of morbidly obese patients undergoing bariatric surgery.', 'detailedDescription': 'It is very important for anesthesiologists to evaluate and make the airway safe in order to start and continue surgical operations. Endotracheal intubation has many important reasons such as ensuring airway control safely during surgical procedure, increasing the depth of anesthesia, need interventions for surgical or anesthetic complications, reduction of dead space, reduction of respiratory effort and prevention of aspiration risk.\n\nMask ventilation and tracheal intubation in morbidly obese patients can be difficult with the anatomical changes caused by obesity. Reduced functional residual capacity in morbidly obese patients makes it difficult to maintain peripheral oxygen saturation at normal limits. Videolaryngoscope, developed in recent years and beginning to take place in the algorithms, facilitate difficult airway management and hence intubation.\n\nThe use of videolaryngoscope in patients with difficult intubation such as morbid obesity, has been frequently reported in the literature. McGrath videolaryngoscope has a high-resolution video camera, a length-adjustable angle blade, and a light source at the tip of the blade. At the same time, the C-MAC videolaryngoscope is another advanced videolaryngoscope with a better quality video and camera system and improves the performance of videolaryngoscope with some technological changes.\n\nIn this prospective controlled clinical study, the purpose is to compare C-MAC videolaryngoscope and McGrath MAC videolaryngoscope in respect to duration of intubation, haemodynamic response, and adverse events associated with intubation of morbidly obese patients undergoing bariatric surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiology score III,\n* 18-65 years,\n* BMI\\> 40\n\nExclusion Criteria:\n\n* American Society of Anesthesiology IV,\n* Under 18 years,\n* Over 65 years,\n* Under BMI\\<40\n* Obstetric patients,\n* Uncontrolled cerebrovascular disease,\n* Patients who refused written informed consent forms'}, 'identificationModule': {'nctId': 'NCT03657927', 'acronym': 'mcgrath&cmac', 'briefTitle': 'A Comparison of McGrath MAC Versus C-MAC Videolaryngoscopes in Morbidly Obese Patients', 'organization': {'class': 'OTHER', 'fullName': 'Inonu University'}, 'officialTitle': 'A Comparison of McGrath® MAC Versus C-MAC® Videolaryngoscopes in Morbidly Obese Patients Undergoing Bariatric Surgery: A Randomized, Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'sedatakbas3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'C-MAC Videolaryngoscope', 'description': 'Morbidly obese patients intubated with C-MAC Videolaryngoscope', 'interventionNames': ['Device: C-MAC videolaryngoscope', 'Device: McGrath MAC videolaryngoscope']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'McGrath MAC Videolaryngoscope', 'description': 'Morbidly obese patients intubated with McGrath MAC Videolaryngoscope', 'interventionNames': ['Device: C-MAC videolaryngoscope', 'Device: McGrath MAC videolaryngoscope']}], 'interventions': [{'name': 'C-MAC videolaryngoscope', 'type': 'DEVICE', 'description': 'An intubating device that is used for endotracheal intubation. Endotracheal intubation was applied by anesthesiologist with C-MAC videolaryngoscope.', 'armGroupLabels': ['C-MAC Videolaryngoscope', 'McGrath MAC Videolaryngoscope']}, {'name': 'McGrath MAC videolaryngoscope', 'type': 'DEVICE', 'description': 'An intubating device that is used for endotracheal intubation. Endotracheal intubation was applied by anesthesiologist with McGrath MAC videolaryngoscope.', 'armGroupLabels': ['C-MAC Videolaryngoscope', 'McGrath MAC Videolaryngoscope']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44090', 'city': 'Malatya', 'state': 'Türkiye-Türkçe', 'country': 'Turkey (Türkiye)', 'facility': 'Sedat AKBAS', 'geoPoint': {'lat': 38.35018, 'lon': 38.31667}}], 'overallOfficials': [{'name': 'Sedat Akbas', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Inonu University Medical Faculty'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inonu University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asst. Prof. Dr. Sedat Akbas', 'investigatorFullName': 'Sedat AKBAS', 'investigatorAffiliation': 'Inonu University'}}}}