Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2026-02-22 @ 6:44 PM
Study NCT ID:
NCT02588157
Status:
COMPLETED
Last Update Posted:
2016-07-20
First Post:
2015-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Cricoid Pressure on Macintosh, McGrath X-Blade and Glidescope Videolaryngoscopes in Rapid Sequence Induction Intubation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-19', 'studyFirstSubmitDate': '2015-10-26', 'studyFirstSubmitQcDate': '2015-10-26', 'lastUpdatePostDateStruct': {'date': '2016-07-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cormack lehane grade with cricoid pressure', 'timeFrame': '1 minutes'}, {'measure': 'intubation time', 'timeFrame': '2 minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Rapid sequence induction intubation', 'McGrath X-Blade', 'Glidescope', 'Macintosh'], 'conditions': ['Rapid Sequence Induction Intubation']}, 'descriptionModule': {'briefSummary': 'Non- Fasted patients need rapid sequence intubation. The investigators aimed to compare the intubation times of Macintosh , and McGrath X-Blade or Glidescope in these Ascenario.', 'detailedDescription': "The investigators fecidedir to enroll the ASA I-II 120 patients and divided them into three groups ( Macintosh / McGarth X-Blade / Glidescope). The investigators recorded the patients' airway data and demographic variables. All patients were premeditated with midazolam. Standard monitoring including electrocardiogram, non invasive blood pressure, pulse oximetry, heart rate were recorded before induction , after induction, after the device insertion and every 1 minutes after intubation. Cormac-Lehan grades with these video laryngoscope were recorded also. We recorded the optimization maneuvers ( like handling force, reinserting, cricoid pressure). Bloodstaining on the devices after removal were recorded as mucosal damage. Teeth, tongue, lip damage were also recorded. Sore throat, bronchospasm, wheezing were recored at recovery unit."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I-II\n* BMI\\< 30\n* 18-65 years of age\n\nExclusion Criteria:\n\n* known difficult airway\n* BMI \\> 30\n* \\< 18 years of age\n* \\> 65 years of age\n* known respiratory tract infection in 10 days\n* pregnant'}, 'identificationModule': {'nctId': 'NCT02588157', 'briefTitle': 'Effect of Cricoid Pressure on Macintosh, McGrath X-Blade and Glidescope Videolaryngoscopes in Rapid Sequence Induction Intubation', 'organization': {'class': 'OTHER', 'fullName': 'Kocaeli University'}, 'officialTitle': 'Videolaryngoscopes for Rapid Sequence Intubation', 'orgStudyIdInfo': {'id': 'KOÜ KAEK 2015/267'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'İnsertion time', 'description': 'handling the device till the glottic visualisation of Macintosh, McGrath MAC X-Blade and Glidescope', 'interventionNames': ['Device: Macintosh', 'Device: Glidescope', 'Device: McGrath MAC X-Blade']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'intubation time', 'description': 'handling the device till seeing the endotracheal tube entering from the vocal cords Macintosh, McGrath MAC X-Blade and Glidescope', 'interventionNames': ['Device: Macintosh', 'Device: Glidescope', 'Device: McGrath MAC X-Blade']}], 'interventions': [{'name': 'Macintosh', 'type': 'DEVICE', 'otherNames': ['direct laryngoscopy'], 'description': 'Direct laryngoscopy', 'armGroupLabels': ['intubation time', 'İnsertion time']}, {'name': 'Glidescope', 'type': 'DEVICE', 'otherNames': ['videolaryngoscope'], 'description': 'Glidescope videolaryngoscope', 'armGroupLabels': ['intubation time', 'İnsertion time']}, {'name': 'McGrath MAC X-Blade', 'type': 'DEVICE', 'otherNames': ['videolaryngoscope'], 'description': 'McGrath MAC X-Blade videolaryngoscope', 'armGroupLabels': ['intubation time', 'İnsertion time']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41900', 'city': 'Kocaeli', 'country': 'Turkey (Türkiye)', 'facility': 'Kocaeli University', 'geoPoint': {'lat': 39.62497, 'lon': 27.51145}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kocaeli University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Zehra Ipek ARSLAN', 'investigatorAffiliation': 'Kocaeli University'}}}}