Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2026-01-25 @ 11:19 AM
Study NCT ID:
NCT02884869
Status:
UNKNOWN
Last Update Posted:
2016-08-31
First Post:
2016-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Direct Laryngoscopy With Blind Intubation Via Intubating Laryngeal Mask Airway
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': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-08-30', 'studyFirstSubmitDate': '2016-08-16', 'studyFirstSubmitQcDate': '2016-08-30', 'lastUpdatePostDateStruct': {'date': '2016-08-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time of blind intubation measure in second', 'timeFrame': '30 seconds', 'description': 'Time of blind intubation in seconds'}], 'secondaryOutcomes': [{'measure': 'Easy to perform intubation measure in numeric scale', 'timeFrame': '30 seconds', 'description': 'Easy of intubation in numerical scale from 1 to 10'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Blind intubation,', 'Laryngeal Mask Airway'], 'conditions': ['Adverse Anesthesia Outcome']}, 'descriptionModule': {'briefSummary': 'Control the airways by endotracheal intubation is an important part of treatment for a trauma casualty. The use of the Laryngeal Mask Airway for fast control of the airway is known for many years. The aim of this study is to examine the effectiveness of the Intubating Laryngeal Mask Airway to achieve a definitive airway by unskilled practitioners.\n\nThe hypothesis is that definitive airway obtaining with Intubating Laryngeal Mask Airway will be more success and faster compared to the standard way of direct laryngoscope.', 'detailedDescription': 'Control the airways and respiration are an important part of treatment for a trauma casualty. Tracheal intubation an action that allows the insertion of a tube through the vocal cords and fixation by the balloon inflation is a definitive airway. The use of the Laryngeal Mask Airway for fast control of the airway is known for many years. The Laryngeal Mask Airway and others similar devices are known as Supraglottic Airway Devices and are inserted blind in the oropharynx and allow a fast oxygenation and ventilation of the patients.The aim of this study is to examine the effectiveness of the Laryngeal Mask Airway to achieve a definitive airway by unskilled practitioners in anesthetized patients with the head in neutral position (trauma model)\n\nThe hypothesis is that definitive airway obtaining with Intubating Laryngeal Mask Airway will be more success and faster compared to the standard way of direct laryngoscope. If the hypothesis is proven, this research will be very important implications for the management of the airway describing pre-hospital and in particular military scenarios.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society Anesthesiology class I and II\n\nExclusion Criteria:\n\n* Difficult airway\n* Cervical pathology\n* Full stomach'}, 'identificationModule': {'nctId': 'NCT02884869', 'briefTitle': 'Comparison of Direct Laryngoscopy With Blind Intubation Via Intubating Laryngeal Mask Airway', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bnai Zion Medical Center'}, 'officialTitle': 'Establishing a Definitive Airway: Comparison of Direct Laryngoscopy With Blind Intubation Via Intubating Laryngeal Mask Airway', 'orgStudyIdInfo': {'id': 'BnaiZionMC-16-LG-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intubating laryngeal Mask', 'description': 'Intubating laryngeal Mask', 'interventionNames': ['Device: Intubating Laryngeal Mask']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Direct laryngoscopy', 'description': 'Intubating laryngeal Mask', 'interventionNames': ['Device: Intubating Laryngeal Mask']}], 'interventions': [{'name': 'Intubating Laryngeal Mask', 'type': 'DEVICE', 'description': 'Direct laryngoscopy', 'armGroupLabels': ['Direct laryngoscopy', 'Intubating laryngeal Mask']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Luis A Gaitini, M.D.', 'role': 'CONTACT', 'email': 'luis.gaitini@b-zion.org.il', 'phone': '# 972 4 8359346'}, {'name': 'Mostafa Somri, M.D.', 'role': 'CONTACT', 'email': 'mostafa.somri@b-zion.org.il', 'phone': '# 972 4 8359346'}], 'overallOfficials': [{'name': 'Luis A Gaitini, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bnai Zion Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bnai Zion Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'LUIS.GAITINI', 'investigatorAffiliation': 'Bnai Zion Medical Center'}}}}