Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT07284251
Status:
COMPLETED
Last Update Posted:
2025-12-16
First Post:
2025-12-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
C-MAC Video Laryngoscope for Double-Lumen Intubation
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': ['INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 252}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-14', 'studyFirstSubmitDate': '2025-12-01', 'studyFirstSubmitQcDate': '2025-12-14', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intubation time', 'timeFrame': 'up to 10 minutes after intubation from recording', 'description': "DLT insertion time was defined as the period from when the intubation device passed the patient's lips until three complete end-tidal carbon dioxide cycles were displayed on the monitor"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Device Performance']}, 'descriptionModule': {'briefSummary': '. The study aimed to compare the C-MAC D-Blade (Group D) and the C-MAC Macintosh blade (Group M) with the conventional direct laryngoscopy macintosh blade (Group DL) in patients with predicted normal airways undergoing thoracic surgery requiring double lumen tube (DLT) placement.', 'detailedDescription': 'The double-lumen tracheal tube (DLT) is the standard device for achieving one-lung ventilation in thoracic surgery. Compared to a single-lumen endotracheal tube, the DLT is longer, stiffer, and has a larger external diameter, making its insertion more challenging. Recently, videolaryngoscopes have been increasingly used in thoracic surgery, particularly in patients with difficult airways, as they enhance visualization of laryngeal structures and facilitate lung separation.However, the role of the videolaryngoscope in DLT intubation remains unclear due to the larger size of the DLT and the discrepancy between the curves of the DLT and the videolaryngoscope blade, which can affect vocal cord visualization and, consequently, intubation success.\n\nVideolaryngoscopes can be classified as standard or hyperangulated based on blade angulation. The results of clinical studies on hyperangulated videolaryngoscopes for DLT placement have been inconsistent, particularly regarding intubation time. While some hyperangulated videolaryngoscopes have demonstrated superiority over the macintosh (Mac) blade laryngoscope in normal airway patients, others have not. These discrepancies may stem from the use of manikins in some studies, variations in clinician experience with videolaryngoscopes, or differences in intubation techniques.\n\nIn patients without predicted difficult airways undergoing thoracic surgery, direct laryngoscopy with a Mac blade remains the recommended technique for DLT placement. The C-MAC videolaryngoscope is designed based on the Mac blade and has been associated with improved laryngeal visualization and reduced need for additional maneuvers to facilitate intubation. The D-blade and Mac blade are adapted for use with the C-MAC system. The C-MAC Mac and D-blade may be a viable alternative to direct laryngoscopy with the Mac blade in routine practice.\n\nThis randomized controlled study aimed to compare the C-MAC D-Blade and the C-MAC Mac blade with the conventional direct laryngoscopy Mac blade in patients with predicted normal airways undergoing thoracic surgery requiring DLT placement. The primary outcome measure was intubation time. Additional parameters assessed included exposure time, the ease of intubation, number of laryngoscopy attempts, and maneuvers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with American Society of Anesthesiologists (ASA) I to III,\n* Patients requiring one-lung ventilation via DLT intubation\n\nExclusion Criteria:\n\n* Patients with a history of difficult endotracheal intubation or mask ventilation,\n* Patients with severe pulmonary ventilation dysfunction,\n* Patients with a risk of pulmonary aspiration patients'}, 'identificationModule': {'nctId': 'NCT07284251', 'briefTitle': 'C-MAC Video Laryngoscope for Double-Lumen Intubation', 'organization': {'class': 'OTHER', 'fullName': 'Inonu University'}, 'officialTitle': 'A Comparison of the D Blade and Mac Blade C-MAC Video Laryngoscope for Double-Lumen Endotracheal Intubation in Patients With Predicted Normal Airways', 'orgStudyIdInfo': {'id': 'INU-AR-FAE-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group D blade', 'description': 'DLT (with the stylet in place) was molded along the blade convexity, and sequential rotation was performed for insertion. After the bronchial lumen tip engaged the glottis, the stylet was removed, and the DLT was rotated 180° counterclockwise to facilitate passage of the bronchial cuff. The DLT was then rotated 90° clockwise to ensure it entered the left main bronchus', 'interventionNames': ['Device: C-MAC Macintosh blade Video Laryngoscope', 'Device: DİRECT Laryngoscopy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group M', 'description': 'once the bronchial cuff had passed through the vocal cords, the double-lumen tube was inserted using the conventional method', 'interventionNames': ['Device: DİRECT Laryngoscopy', 'Device: D blade CMac videolaryngoscopy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group DL (Direct laryngoscopy macintosch blade, conventional . placebo)', 'description': 'once the bronchial cuff had passed through the vocal cords, the double-lumen tube was inserted using the conventional method', 'interventionNames': ['Device: C-MAC Macintosh blade Video Laryngoscope', 'Device: D blade CMac videolaryngoscopy']}], 'interventions': [{'name': 'C-MAC Macintosh blade Video Laryngoscope', 'type': 'DEVICE', 'description': 'videolaryngoscopes have been increasingly used in thoracic surgery, particularly in patients with difficult airways, as they enhance visualization of laryngeal structures and facilitate lung separationThe D-blade and Mac blade are adapted for use with the C-MAC system.10 The C-MAC Mac and D-blade may be a viable alternative to direct laryngoscopy with the Mac blade in routine practice.', 'armGroupLabels': ['Group D blade', 'Group DL (Direct laryngoscopy macintosch blade, conventional . placebo)']}, {'name': 'DİRECT Laryngoscopy', 'type': 'DEVICE', 'description': 'In patients without predicted difficult airways undergoing thoracic surgery, direct laryngoscopy with a Mac blade remains the recommended technique for DLT placement', 'armGroupLabels': ['Group D blade', 'Group M']}, {'name': 'D blade CMac videolaryngoscopy', 'type': 'DEVICE', 'description': 'videolaryngoscopes have been increasingly used in thoracic surgery, particularly in patients with difficult airways, as they enhance visualization of laryngeal structures and facilitate lung separation', 'armGroupLabels': ['Group DL (Direct laryngoscopy macintosch blade, conventional . placebo)', 'Group M']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44280', 'city': 'Malatya', 'state': 'Battalgazi', 'country': 'Turkey (Türkiye)', 'facility': 'inonu University', 'geoPoint': {'lat': 38.35018, 'lon': 38.31667}}], 'overallOfficials': [{'name': 'Yeliz tunc ozer, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inonu University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inonu University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor Doctor', 'investigatorFullName': 'FERAY AKGUL ERDIL', 'investigatorAffiliation': 'Inonu University'}}}}