Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:50 PM
Study NCT ID:
NCT01347151
Status:
UNKNOWN
Last Update Posted:
2011-05-04
First Post:
2011-05-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Comparison of Cervical Spine Movement During Tracheal Intubation Using the Pentax or the Glidescope
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': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2011-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-05-03', 'studyFirstSubmitDate': '2011-05-02', 'studyFirstSubmitQcDate': '2011-05-03', 'lastUpdatePostDateStruct': {'date': '2011-05-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the angular displacement of the vertebrae', 'timeFrame': '30 seconds', 'description': 'during intubation'}], 'secondaryOutcomes': [{'measure': 'the hemodynamic changes after intubation.', 'timeFrame': '15 minutes', 'description': 'after intubation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Glide scope', 'Pentax', 'C spine movement'], 'conditions': ['C-spine Movement During Intubation']}, 'descriptionModule': {'briefSummary': 'Both Glide scope and Pentax laryngoscope are video laryngoscope that provide the better view with minimal cervical spine movement. This study wants to compare cervical spine movement during intubation when using these two devices. The C-spine motion will be recorded by using fluoroscopic video to measure the angular displacement of the vertebrae.', 'detailedDescription': 'The primary outcome is the angular displacement of the vertebrae and secondary outcome is the hemodynamic changes after intubation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I-III\n* Age 18-75 years old\n* Elective noncardiac surgery requiring general anesthesia with tracheal intubation\n\nExclusion Criteria:\n\n* Gastroesophageal reflux disease\n* Body mass index greater than 35 kg/m2\n* Possibility of pregnancy\n* Previous neck surgery\n* Unstable C-spine/ C-spine abnormality\n* Known difficult airway\n* Suspected difficult airway'}, 'identificationModule': {'nctId': 'NCT01347151', 'briefTitle': 'A Comparison of Cervical Spine Movement During Tracheal Intubation Using the Pentax or the Glidescope', 'organization': {'class': 'OTHER', 'fullName': 'Prince of Songkla University'}, 'orgStudyIdInfo': {'id': 'Glide VS Pentax'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Glide scope', 'interventionNames': ['Device: The glidescope video laryngoscopy']}, {'type': 'EXPERIMENTAL', 'label': 'Pentax airway scope', 'interventionNames': ['Device: The Pentax airwayscope']}], 'interventions': [{'name': 'The glidescope video laryngoscopy', 'type': 'DEVICE', 'armGroupLabels': ['Glide scope']}, {'name': 'The Pentax airwayscope', 'type': 'DEVICE', 'otherNames': ['The Pentax airwayscope (Pentax AWS; Pentax, Tokyo, Japan)'], 'armGroupLabels': ['Pentax airway scope']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90110', 'city': 'Hat Yai', 'state': 'Changwat Songkhla', 'country': 'Thailand', 'facility': 'Songklanagarind Hospital', 'geoPoint': {'lat': 7.00836, 'lon': 100.47668}}], 'overallOfficials': [{'name': 'Nalinee Kovitwanawong, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Depatment of Anesthesiology Faculty of Medicine Prince of Songkla University Thailand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prince of Songkla University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Assistant Professor Nalinee Kovitwanawong', 'oldOrganization': 'Department of anesthesiology Faculty of Medicine Prince of Songkla University Thailand'}}}}