Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2026-02-26 @ 5:59 AM
Study NCT ID:
NCT01789034
Status:
UNKNOWN
Last Update Posted:
2013-02-12
First Post:
2013-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Difficult Intubation With Glidescope Video Laryngoscope
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2013-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-02-11', 'studyFirstSubmitDate': '2013-02-08', 'studyFirstSubmitQcDate': '2013-02-08', 'lastUpdatePostDateStruct': {'date': '2013-02-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of difficult intubation using Adnet score modified', 'timeFrame': '3 years', 'description': 'Difficult intubation in the current study is measured using Adnet score including the number of laryngoscopies'}], 'secondaryOutcomes': [{'measure': 'incidence of difficult intubations in novices vs experts and complication in the overall cohort', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Difficult Intubation', 'Complications']}, 'descriptionModule': {'briefSummary': 'A prospective observational study on predictors available and on variables of difficult intubation adopting Gliscope video laryngoscope routinely.\n\nPrimary hypothesis of the current study is that the rate of difficult intubation with Glidescope is low and multiple predictors interact favorably in anticipating difficulties.', 'detailedDescription': 'All possible factors involved in difficult intubations were included in this prospective analysis.\n\nMain predictors were considered: time to Cormack Lane using Glidescope intubation, Cormack Lane score, experience of the operator (staff or resident), number of bag mask ventilation, number of intubation attempts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing neurosurgical procedures eligible for intubation in a tertiary neurosurgical centre', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* any patient up to ASA4 eligible for intubation for neurosurgical procedures\n* any anesthesiologist in charge for GA\n\nExclusion Criteria:\n\n* children\n* patient not suitable for clinical evaluation of predictors for difficult intubation (ie. Parkinson's disease)"}, 'identificationModule': {'nctId': 'NCT01789034', 'briefTitle': 'Difficult Intubation With Glidescope Video Laryngoscope', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta'}, 'officialTitle': 'Incidence and Predictors of Difficult Intubation Adopting an Institutional Algorithm Glidescope Based: a Cohort Study', 'orgStudyIdInfo': {'id': 'Besta-2012-01'}}, 'contactsLocationsModule': {'locations': [{'zip': '20136', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Paolo Cortellazzi, MD', 'role': 'CONTACT', 'email': 'doclampmd@gmail.com', 'phone': '+39022394', 'phoneExt': '2420'}], 'facility': 'Istituto Neurologico Besta', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}], 'centralContacts': [{'name': 'Paolo Cortellazzi, MD', 'role': 'CONTACT', 'email': 'paolo.cortellazzi@istituto-besta.it', 'phone': '+3902239', 'phoneExt': '2420'}, {'name': 'Paolo Cortellazzi, MD', 'role': 'CONTACT', 'email': 'paolo.cortellazzi@istituto-besta.it', 'phone': '+29022394', 'phoneExt': '2420'}], 'overallOfficials': [{'name': 'Paolo Cortellazzi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istituto Nazionale Neurologico Carlo Besta'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Neuroanesthesia Department', 'investigatorFullName': 'Massimo Lamperti', 'investigatorAffiliation': 'Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta'}}}}