Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT04757558
Status:
UNKNOWN
Last Update Posted:
2021-02-17
First Post:
2021-02-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
C-MAC Video-stylet for Double- Lumen Tracheal Intubation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-13', 'studyFirstSubmitDate': '2021-02-13', 'studyFirstSubmitQcDate': '2021-02-13', 'lastUpdatePostDateStruct': {'date': '2021-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the time taken for intubation (TTI) by C-MAC-VS', 'timeFrame': '5 minutes', 'description': 'timing for intubation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Single Lung Ventilation', 'Thoracic Anesthesia']}, 'descriptionModule': {'briefSummary': 'C-MAC Video Stylet secures the airway. It is a completely new type of video endoscope, it combines the advantages of both rigid and flexible intubation endoscopes. Video allows everyone involved in the intubation to visualize the anatomy simultaneously which facilitates communication and teamwork.', 'detailedDescription': "It can be connected easily to the same C- MAC monitor and Pocket Monitor without requiring any additional light source and camera. Video allows everyone involved in the intubation to visualize the anatomy simultaneously which facilitates communication and teamwork. The device has no lumens so it's very easy to clean. Basically if you can get a tube between the cheek and teeth you can intubate the patient."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 18-60 years,\n* of both sex\n* of American Society of Anesthesiologists (ASA) physical Status II and III\n* undergoing elective intra-thoracic surgeries requiring double lumen intubation. BMI -\\< 35 kg/m2,\n* with Mallampati score of 1 or 2\n\nExclusion Criteria:\n\n* Mallampati score \\> =3;\n* inter-incisor distance \\< 3 cm;\n* thyromental distance \\< 6 cm;\n* neck extension \\< 80°from neck flexion;\n* cervical spine instability;\n* history of difficult endotracheal intubation\n* r difficult mask ventilation; - severe pulmonary ventilation dysfunction\n* risk of pulmonary aspiration.'}, 'identificationModule': {'nctId': 'NCT04757558', 'briefTitle': 'C-MAC Video-stylet for Double- Lumen Tracheal Intubation', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'C-MAC Video-stylet for Double- Lumen Tracheal Intubation: a Prospective Randomized Study', 'orgStudyIdInfo': {'id': '0304793'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'C-MAC-VS group', 'description': 'C-MAC-VS will be used to facilitate intubation', 'interventionNames': ['Device: C-MAC video-stylet']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control group', 'description': 'direct laryngoscopy using Macintosh laryngoscope will be done for DLT insertion.', 'interventionNames': ['Device: Macintosh laryngoscope']}], 'interventions': [{'name': 'C-MAC video-stylet', 'type': 'DEVICE', 'description': 'Patients will be randomly assigned two group 40 patients each, C-MAC-VS group (VS group) (Karl Storz GmbHand Co.KG, Germany), and control group (C group). This will be done using a closed envelope technique using a computer-generated block randomization method.', 'armGroupLabels': ['C-MAC-VS group']}, {'name': 'Macintosh laryngoscope', 'type': 'DEVICE', 'description': 'Patients will be randomly assigned two group 40 patients each, C-MAC-VS group (VS group) (Karl Storz GmbHand Co.KG, Germany), and control group (C group). This will be done using a closed envelope technique using a computer-generated block randomization method.', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '000000', 'city': 'Alexandria', 'country': 'Egypt', 'facility': 'rehab Abd Elaziz', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'overallOfficials': [{'name': 'rehab A. Abd Elaziz, Ass.Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alexandria University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assisstant Professor of Anesthesia', 'investigatorFullName': 'rehab zayed', 'investigatorAffiliation': 'Alexandria University'}}}}