Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-03-06 @ 10:14 AM
Study NCT ID:
NCT03071367
Status:
COMPLETED
Last Update Posted:
2017-03-07
First Post:
2017-03-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison of Clinical Simulation and Classical Learning for Airway Management in Medical Students
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2014-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-06', 'studyFirstSubmitDate': '2017-03-01', 'studyFirstSubmitQcDate': '2017-03-03', 'lastUpdatePostDateStruct': {'date': '2017-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-02-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Airway management score', 'timeFrame': '28 days'}], 'secondaryOutcomes': [{'measure': 'Successful intubation rate', 'timeFrame': '28 days'}, {'measure': 'Incidence of complications', 'timeFrame': '28 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Airway Management', 'Medical students', 'Intratracheal intubation', 'Educational Technology'], 'conditions': ['Educational Activities']}, 'descriptionModule': {'briefSummary': 'Multiple studies have shown clinical simulation benefits over classical learning method. Research on simulation of airway management has focused on endotracheal intubation training, while research on ventilation via facemask is scant. The investigators compared both learning methods regarding the acquirement of basic skills for airway management by medical students. Students in the clinical simulation group received a 3-hour training on airway management on the first day of their 28-day anesthesia rotation, while classical learning did not. On the last day of rotation, participants were evaluated based on a validated instrument of scores. Primary outcome was airway management scores. Secondary outcomes were rate of success of intubation and incidence of complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Last year medical students at Universidad de los Andes\n* Over 18 year old\n\nExclusion Criteria:\n\n* Previous elective anesthesia rotation\n* Motor deficit affecting the upper limbs'}, 'identificationModule': {'nctId': 'NCT03071367', 'briefTitle': 'A Comparison of Clinical Simulation and Classical Learning for Airway Management in Medical Students', 'organization': {'class': 'OTHER', 'fullName': 'Fundación Santa Fe de Bogota'}, 'officialTitle': 'Title: A Comparison of Clinical Simulation and Classical Learning for Airway Management in Medical Students: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CCEI-1357-2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clinical Simulation', 'interventionNames': ['Other: Clinical Simulation']}, {'type': 'NO_INTERVENTION', 'label': 'Classical Learning'}], 'interventions': [{'name': 'Clinical Simulation', 'type': 'OTHER', 'armGroupLabels': ['Clinical Simulation']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación Santa Fe de Bogota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anesthesiologist', 'investigatorFullName': 'Leopoldo Ferrer', 'investigatorAffiliation': 'Fundación Santa Fe de Bogota'}}}}