Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-27 @ 10:57 PM
Study NCT ID:
NCT01032460
Status:
COMPLETED
Last Update Posted:
2010-11-09
First Post:
2009-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Two Novel Indirect Laryngoscopes to the Macintosh Laryngoscope in Patients With Cervical Spine Immobilization.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-08', 'studyFirstSubmitDate': '2009-12-14', 'studyFirstSubmitQcDate': '2009-12-14', 'lastUpdatePostDateStruct': {'date': '2010-11-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of successful placement of Tube in the Trachea a. Failed intubation defined as requiring greater than 60s or which resulted in Oesophageal Intubation. b. Successful intubation confirmed by an investigator.', 'timeFrame': 'immediately'}], 'secondaryOutcomes': [{'measure': 'Duration of Intubation attempt (successful Attempts only) a. Absolute time taken to perform successful tracheal intubation b. Number of successful intubations completed within 30 seconds.', 'timeFrame': 'immediatley'}, {'measure': 'Tracheal Intubation attempts. a. Overall number of attempts at Intubation. b. Number of successful intubations on first attempt', 'timeFrame': 'immediately'}, {'measure': 'Laryngeal View Obtained a. Cormac and Lehane Grading of Best Laryngeal View b. POGO score', 'timeFrame': 'immediately'}, {'measure': 'Intubation Difficulty Scale score', 'timeFrame': 'immediately'}, {'measure': 'Need for and number of optimisation Manoeuvres to aid tracheal intubation', 'timeFrame': 'immediately'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['airway', 'airway device', 'cervical spine immobilisation'], 'conditions': ['Immobilization']}, 'descriptionModule': {'briefSummary': 'It is essential that anaesthetists successfully perform orotracheal intubation in scenarios in which intubation is potentially more difficult, such as where the neck is immobilized.\n\nThe Airtraq® Laryngoscope and the CMAC are new intubating devices. They are designed to provide a view of the glottis without alignment of the oral, pharyngeal and tracheal axes.\n\nThese devices may be especially effective in situations where intubation of the trachea is potentially difficult.\n\nThe efficacy of these devices in comparison to the traditional Macintosh laryngoscope in situations where the cervical spine is immobilized is not known.\n\nThe investigators aim to compare the performances of the Airtraq® Laryngoscope and the CMAC to that of the Macintosh laryngoscope, the gold standard device, in patients in which the cervical spine has been immobilized by means of a Manual in-line stabilization of the spine.\n\nHypothesis: The primary hypothesis is that, in the hands of experienced anaesthetists, time to intubation would be shorter using the indirect laryngoscopes, than using the Macintosh laryngoscope in simulated difficult laryngoscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA 1 - 3\n* Aged 18 - 85 years\n* Written informed Consent\n* No relevant drug allergies\n* Mallampatti 1 - 2.\n\nExclusion Criteria:\n\n* Patients unable to cooperate with airway assessment (2)\n* Patients with predicted difficult intubation\n\n * Mallampatti III or IV\n * Thyromental distance \\< 6cm\n * Mouth opening \\< 3.5 cm\n * Cervical spine disease\n * Anteriorly protruding incisors\n * Poor Dentition (2)\n * Tumours, polyps or foreign bodies in the upper airway (2)\n * Patients with documented difficult airways (2).\n * Patients with history of or risk factors for gastric regurgitation (i.e. require rapid sequence induction of anaesthesia)'}, 'identificationModule': {'nctId': 'NCT01032460', 'briefTitle': 'Comparison of Two Novel Indirect Laryngoscopes to the Macintosh Laryngoscope in Patients With Cervical Spine Immobilization.', 'organization': {'class': 'OTHER', 'fullName': 'University College Hospital Galway'}, 'orgStudyIdInfo': {'id': 'CMAC-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'macintosh', 'interventionNames': ['Device: intubate with the macintosh laryngoscope']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'C-MAC', 'interventionNames': ['Device: intubate with the C-MAC laryngoscope']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Airtraq', 'interventionNames': ['Device: intubate with the Airtraq device']}], 'interventions': [{'name': 'intubate with the macintosh laryngoscope', 'type': 'DEVICE', 'description': 'intubate with the macintosh laryngoscope', 'armGroupLabels': ['macintosh']}, {'name': 'intubate with the C-MAC laryngoscope', 'type': 'DEVICE', 'description': 'intubate with the C-MAC laryngoscope', 'armGroupLabels': ['C-MAC']}, {'name': 'intubate with the Airtraq device', 'type': 'DEVICE', 'description': 'intubate with the Airtraq device', 'armGroupLabels': ['Airtraq']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Galway', 'state': 'Galway', 'country': 'Ireland', 'facility': 'Galway University Hospital', 'geoPoint': {'lat': 53.27245, 'lon': -9.05095}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College Hospital Galway', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'John G Laffey', 'oldOrganization': 'National University of Ireland, Galway'}}}}