Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-02-26 @ 12:37 AM
Study NCT ID:
NCT01974505
Status:
UNKNOWN
Last Update Posted:
2013-11-01
First Post:
2013-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Learning Curve of Optiscope by Anesthesia Providers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2014-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-10-28', 'studyFirstSubmitDate': '2013-10-28', 'studyFirstSubmitQcDate': '2013-10-28', 'lastUpdatePostDateStruct': {'date': '2013-11-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time to intubation', 'timeFrame': 'intubation period', 'description': 'Time to intubation (from optiscope insertion to the detection of end tidal CO2) will be recorded. If time to inubation is longer than 180 s or pulse oxymetry is lower than 94%, mask ventilation will be performed. If intubation is not successful within 3 trials, it will be performed using direct laryngoscope.'}]}, 'conditionsModule': {'conditions': ['Intubation, Intratracheal']}, 'descriptionModule': {'briefSummary': 'Optiscope (Clarus Medical, Minneapolis, MN, USA) is a semi-rigid fiberscope for endotracheal intubation. This study will investigate learning curve of Optiscope by anesthesia providers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient who is scheduled general anesthesia for elective surgery\n\nExclusion Criteria:\n\n* patient who is anticipated difficult airway\n* patient who is needed rapid sequence induction\n* Cervical injury'}, 'identificationModule': {'nctId': 'NCT01974505', 'briefTitle': 'Learning Curve of Optiscope by Anesthesia Providers', 'organization': {'class': 'OTHER', 'fullName': 'Jeju National University School of Medicine'}, 'officialTitle': 'Learning Curve of Optiscope by Anesthesia Providers', 'orgStudyIdInfo': {'id': 'JejuNationalUniversityHospital'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intubation using optiscope', 'description': 'The investigators are novice on optiscope. They will perform intubation using optiscope to patients scheduled elective surgery.', 'interventionNames': ['Device: intubation using optiscope']}], 'interventions': [{'name': 'intubation using optiscope', 'type': 'DEVICE', 'description': 'Optiscope (Clarus Medical, Minneapolis, MN, USA) is a semi-rigid fiberscope designed for endotracheal intubation. Anesthetic providers who are novice on optiscope will perform intubation using optiscope.', 'armGroupLabels': ['intubation using optiscope']}]}, 'contactsLocationsModule': {'locations': [{'zip': '690-767', 'city': 'Jeju City', 'state': 'Jeju Special Self-Governing Province', 'country': 'South Korea', 'contacts': [{'name': 'Jong Cook Park, professor', 'role': 'CONTACT', 'email': 'pjcook@cheju.ac.kr', 'phone': '82-64-717-2029'}, {'name': 'Hyun Jung Kim, assistant professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Jeju National University Hospital', 'geoPoint': {'lat': 33.50972, 'lon': 126.52194}}], 'centralContacts': [{'name': 'Hyun Jung Kim, MD, PhD', 'role': 'CONTACT', 'email': 'hjanesthesia@empas.com', 'phone': '82-64-717-2026'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jeju National University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Hyun Jung Kim', 'investigatorAffiliation': 'Jeju National University School of Medicine'}}}}