Ignite Creation Date:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2026-02-04 @ 1:04 PM
Study NCT ID:
NCT04183959
Status:
COMPLETED
Last Update Posted:
2020-07-30
First Post:
2019-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intubating Video Stylet Versus Fiberoptic Intubating Bronchoscope.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D055100', 'term': 'Optical Fibers'}], 'ancestors': [{'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-07-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-28', 'studyFirstSubmitDate': '2019-11-29', 'studyFirstSubmitQcDate': '2019-12-02', 'lastUpdatePostDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intubation time', 'timeFrame': 'up to 1 hour', 'description': '(defined as the time when the device is introduced into the mouth till it is removed after the confirmation of correct placement of ETT by the appearance of an optimal waveform on the capnograph'}], 'secondaryOutcomes': [{'measure': 'Intubation success rate', 'timeFrame': 'up to 1 hour', 'description': 'Intubation success rate'}, {'measure': 'Number of intubation attempts', 'timeFrame': 'up to 1 hour', 'description': 'Number of intubation attempts'}, {'measure': 'Hemodynamic stability', 'timeFrame': 'up to 1 hour', 'description': 'assessed based on MAP and HR, which will be measured at the following time intervals: before induction of anesthesia at baseline (BA), after induction of anesthesia but before tracheal intubation (T1), and immediately after successful intubation (T2)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intubating Video Stylet']}, 'descriptionModule': {'briefSummary': 'the video stylet (VS), it is considered one of the newer devices in this category. It is a portable device with liquid crystal-display module screen for visualization of vocal cords. It is considered an alternative to the flexible fiberoptic endoscope especially in the developing countries where the device cost is the main limiting factor. It has many benefits such as being light weight, easy to clean, durable, chargeable, less expensive and reusable. However newer video stylet devices have not been formally evaluated for tracheal intubation in case of laterally positioned patients.', 'detailedDescription': "Following approval from Ethics and Research Committee of Theodor Bilharz Research Institute, the study protocol will be explained to the patients after taking their consent.\n\nUpon arrival to the operating room, a 20 G cannula will be sited intravenously and infusion of Ringer's solution will be started. Intravenous midazolam in a dose of 0.05 mg/ Kg will be given. Then, a five-lead electrocardiogram (GE-Datex Ohmeda 5 lead ECG cable), a pulse oximeter (GE- Datex Ohmeda adult finger spO2 sensor) and a non-invasive blood pressure monitor (GE-Datex Ohmeda NIBP cuff, adult double tube with bag) will be attached to the patient."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient age 18- 60 years.\n* Both sexes\n* American Society of Anesthesiologists(ASA) physical status classes I and II.\n* Non-obese patients ( BMI \\<35)\n\nExclusion Criteria:\n\n* Difficult intubation; mallampati 3 or 4, Dental abnormalities, Cervical spine pathology that limits neck mobility , obese patients ( BMI ≥ 35) .\n* Cardiovascular disease, hypertensive patients, Pregnant and nursing women, High risk of pulmonary aspiration.\n* Patients at risk of bleeding either impaired bleeding profile or receiving anticoagulants'}, 'identificationModule': {'nctId': 'NCT04183959', 'briefTitle': 'Intubating Video Stylet Versus Fiberoptic Intubating Bronchoscope.', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Intubating Video Stylet Versus Fiberoptic Intubating Bronchoscope. A Randomised Comparative Study for Intubation in Lateral Position.', 'orgStudyIdInfo': {'id': 'MD-53-2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group- video stylet intubation (VS)', 'description': 'trachea will be intubated using laryngoscopic assisted video stylet device in lateral position', 'interventionNames': ['Device: video stylet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group- fiberoptic intubation (FO)', 'description': ': intubation will be done using fiberoptic device by the same anesthesiologist in lateral position', 'interventionNames': ['Device: fiberoptic']}], 'interventions': [{'name': 'video stylet', 'type': 'DEVICE', 'description': 'trachea will be intubated using laryngoscopic assisted video stylet device in lateral position', 'armGroupLabels': ['Group- video stylet intubation (VS)']}, {'name': 'fiberoptic', 'type': 'DEVICE', 'description': 'intubation will be done using fiberoptic device by the same anesthesiologist in lateral position', 'armGroupLabels': ['Group- fiberoptic intubation (FO)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11451', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of Medicine, Cairo University.', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Nesrine Elrefai, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor of Anaesthesia, surgical ICU &Pain management'}, {'name': 'Sohaila Omar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor of Anaesthesia and surgical ICU'}, {'name': 'Mohamed Hussien, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lecturer of Anaesthesia and surgical ICU'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Still working'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Theodor Bilharz Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Anesthesia, Pain management and Surgical ICU', 'investigatorFullName': 'Amr Samir Wahdan', 'investigatorAffiliation': 'Cairo University'}}}}