Ignite Creation Date:
2025-12-24 @ 4:09 PM
Ignite Modification Date:
2026-01-29 @ 10:27 AM
Study NCT ID:
NCT03046966
Status:
COMPLETED
Last Update Posted:
2021-07-07
First Post:
2017-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Manikin To Patient Intubation: Does It Translate?
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Jarumpel@uams.edu', 'phone': '501-364-2980', 'title': 'Jennifer Rumpel, MD', 'organization': 'University of Arkansas for Medical Sciences'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'NICU rotation (1 month)', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention Control: No Training', 'description': 'Does not receive hands-on intubation training in the Simulation Lab.\n\nIntervention: Control No Training: • Does not receive simulation training with PI. Only standard training.', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 0, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Intervention: Receives Training', 'description': 'Receives hands-on intubation training in the Simulation Lab.\n\nIntervention: Receives Training: • Complete a Hands-on Intubation in the Simulation Lab with PI instructing:\n\n* Using state of the art technology, a Storz C-MAC video laryngoscope\n* Identifying anatomical landmarks\n* Practice on the manikin until intubation occurs within 15 seconds', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 0, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Successful Intubation Encounters on Live Neonates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}, {'units': 'Intubation Encounters', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Control: No Training Residents received standard training consisting of intern orientation.'}, {'id': 'OG001', 'title': 'Intervention Group', 'description': 'Intervention Group: Received individualized with a neonatologist at the beginning of the NICU rotation utilizing video laryngoscope and a neonatal mannequin. These residents also received standard training at intern orientation.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.02', 'spread': '0.167', 'groupId': 'OG000'}, {'value': '1.18', 'spread': '0.183', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month- neonatal intensive care unit (NICU) rotation', 'description': 'Residents reported the number of successful intubation encounters they performed during their one month long NICU rotation. A successful intubation encounter is an intubation procedure where the resident successfully placed the the endotracheal tube (ETT) through the vocal cords into the trachea. Placement was confirmed with xray, chest auscultation, improvement in heart rate, and CO2 detectors.', 'unitOfMeasure': 'Successful Intubation Encounters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Intubation Encounters', 'denomUnitsSelected': 'Intubation Encounters'}, {'type': 'SECONDARY', 'title': 'Successful Intubations on the First Attempt', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Control: No Training Residents received standard training consisting of intern orientation.'}, {'id': 'OG001', 'title': 'Intervention Group', 'description': 'Intervention Group: Received individualized with a neonatologist at the beginning of the NICU rotation utilizing video laryngoscope and a neonatal mannequin. These residents also received standard training at intern orientation.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.578', 'spread': '0.133', 'groupId': 'OG000'}, {'value': '0.840', 'spread': '0.161', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month- NICU rotation', 'description': "Each resident reported the number of successful intubation encounters requiring one attempt on live infants during their NICU rotation. An intubation attempt occurs any time the laryngoscope enters the neonate's mouth. There can be multiple intubation attempts in one intubation encounter. However this outcome focuses on intubation encounters where the neonate was intubated on the first attempt by the resident.", 'unitOfMeasure': 'Successful First Attempt Intubations', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Six residents in the Control group did not report the number of successful intubation encounters completed with only one attempt.'}, {'type': 'SECONDARY', 'title': 'Total Number of Intubation Encounters Performed by Each Resident During Their NICU Rotation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Control: No Training Residents received standard training consisting of intern orientation.'}, {'id': 'OG001', 'title': 'Intervention Group', 'description': 'Intervention Group: Received individualized with a neonatologist at the beginning of the NICU rotation utilizing video laryngoscope and a neonatal mannequin. These residents also received standard training at intern orientation.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.82', 'spread': '0.189', 'groupId': 'OG000'}, {'value': '2.33', 'spread': '0.214', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month- NICU rotation', 'description': 'The mean number of intubation encounters performed by each resident during their NICU rotation was compared between the Control and Intervention groups.', 'unitOfMeasure': 'Intubation Encounters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Time to Intubate the Mannequin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Control: No Training Residents received standard training consisting of intern orientation.'}, {'id': 'OG001', 'title': 'Intervention Group', 'description': 'Intervention Group: Received individualized with a neonatologist at the beginning of the NICU rotation utilizing video laryngoscope and a neonatal mannequin. These residents also received standard training at intern orientation.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.6', 'spread': '9.61', 'groupId': 'OG000'}, {'value': '37.6', 'spread': '8.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month- NICU rotation', 'description': 'All study residents intubated the mannequin before and after their NICU rotation. The total time of the mannequin intubation encounter was recorded. The difference in the time from end of the NICU rotation and the baseline time (beginning of the NICU rotation) was calculated.', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention Control: No Training', 'description': 'Does not receive hands-on intubation training in the Simulation Lab.\n\nIntervention: Control No Training: • Does not receive simulation training with PI. Only standard training.'}, {'id': 'FG001', 'title': 'Intervention: Receives Training', 'description': 'Receives hands-on intubation training in the Simulation Lab.\n\nIntervention: Receives Training: • Complete a Hands-on Intubation in the Simulation Lab with PI instructing:\n\n* Using state of the art technology, a Storz C-MAC video laryngoscope\n* Identifying anatomical landmarks\n* Practice on the manikin until intubation occurs within 15 seconds'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '102 residents were approached for enrollment. 102 residents were consented and randomized to intervention or control based on month of NICU rotation.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control Group', 'description': 'Control: No Training Residents received standard training consisting of intern orientation.'}, {'id': 'BG001', 'title': 'Intervention Group', 'description': 'Intervention Group: Received individualized with a neonatologist at the beginning of the NICU rotation utilizing video laryngoscope and a neonatal mannequin. These residents also received standard training at intern orientation.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Level of Training (year)', 'classes': [{'title': 'First year', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}]}, {'title': 'Second year', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'Third year', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'Fourth Year', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Comfort with Intubation', 'classes': [{'categories': [{'title': 'Not very comfortable', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'Somewhat comfortable', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Neutral', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Comfortable', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Very comfortable', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline Successful Intubation Rate', 'classes': [{'categories': [{'title': '0-25%', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': '25-50%', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': '50-75%', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': '75-100%', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Not Applicable', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-09-19', 'size': 291393, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-05-14T20:54', 'hasProtocol': True}, {'date': '2017-09-19', 'size': 99515, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-06-18T09:47', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-02', 'studyFirstSubmitDate': '2017-02-02', 'resultsFirstSubmitDate': '2021-05-17', 'studyFirstSubmitQcDate': '2017-02-06', 'lastUpdatePostDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-07-02', 'studyFirstPostDateStruct': {'date': '2017-02-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful Intubation Encounters on Live Neonates', 'timeFrame': '1 month- neonatal intensive care unit (NICU) rotation', 'description': 'Residents reported the number of successful intubation encounters they performed during their one month long NICU rotation. A successful intubation encounter is an intubation procedure where the resident successfully placed the the endotracheal tube (ETT) through the vocal cords into the trachea. Placement was confirmed with xray, chest auscultation, improvement in heart rate, and CO2 detectors.'}], 'secondaryOutcomes': [{'measure': 'Successful Intubations on the First Attempt', 'timeFrame': '1 month- NICU rotation', 'description': "Each resident reported the number of successful intubation encounters requiring one attempt on live infants during their NICU rotation. An intubation attempt occurs any time the laryngoscope enters the neonate's mouth. There can be multiple intubation attempts in one intubation encounter. However this outcome focuses on intubation encounters where the neonate was intubated on the first attempt by the resident."}, {'measure': 'Total Number of Intubation Encounters Performed by Each Resident During Their NICU Rotation', 'timeFrame': '1 month- NICU rotation', 'description': 'The mean number of intubation encounters performed by each resident during their NICU rotation was compared between the Control and Intervention groups.'}, {'measure': 'Change in Time to Intubate the Mannequin', 'timeFrame': '1 month- NICU rotation', 'description': 'All study residents intubated the mannequin before and after their NICU rotation. The total time of the mannequin intubation encounter was recorded. The difference in the time from end of the NICU rotation and the baseline time (beginning of the NICU rotation) was calculated.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intubation; Difficult or Failed']}, 'referencesModule': {'references': [{'pmid': '36369530', 'type': 'DERIVED', 'citation': "Rumpel J, O'Neal L, Kaukis N, Rogers S, Stack J, Hollenberg J, Hall RW. Manikin to patient intubation: does it translate? J Perinatol. 2023 Feb;43(2):233-235. doi: 10.1038/s41372-022-01553-9. Epub 2022 Nov 11. No abstract available."}]}, 'descriptionModule': {'briefSummary': 'This study evaluates a new approach to the instruction of pediatric residents in the skill of neonatal intubation. Half of the participants will receive focused simulation training and cognitive instruction while the other half will not. The collected data from both groups will be compared.', 'detailedDescription': 'Current findings suggest that the training of pediatric residents is not sufficient prior to "live" tracheal intubations in the critical care setting. The current one to two days of airway management training as a part of resuscitation training (such as Pediatric Advanced Life Support (PALS) or Neonatal Resuscitation Program (NRP) is not sufficient to provide safe intubation skills.\n\nThis study will develop and implement tracheal intubation training using concepts of deliberate practice modeled after Ericsson. The concepts include focused training on a specific task, immediate feedback, time for problem solving and evaluation, and opportunities for repeated performance using a manikin. This proposal is an attempt to develop such a training model. Video recordings of live intubations will be reviewed and evaluated. The data between the two groups will be compared to see if there is improved intubation skills of live patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female residents from 18-89 years of age who have been assigned to the Neonatal Intensive Care Unit (NICU) for a monthly rotation are eligible to participate. At the beginning of all NICU rotations, all pediatric residents will be invited to participate in this research.\n\nExclusion Criteria:\n\n* Any pediatric resident who does not wish to participate'}, 'identificationModule': {'nctId': 'NCT03046966', 'briefTitle': 'Manikin To Patient Intubation: Does It Translate?', 'organization': {'class': 'OTHER', 'fullName': 'University of Arkansas'}, 'officialTitle': 'Manikin To Patient Intubation: Does It Translate?', 'orgStudyIdInfo': {'id': '205053'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Intervention Control: No Training', 'description': 'Does not receive hands-on intubation training in the Simulation Lab.', 'interventionNames': ['Other: Intervention: Control No Training']}, {'type': 'OTHER', 'label': 'Intervention: Receives Training', 'description': 'Receives hands-on intubation training in the Simulation Lab.', 'interventionNames': ['Procedure: Intervention: Receives Training']}], 'interventions': [{'name': 'Intervention: Receives Training', 'type': 'PROCEDURE', 'description': '• Complete a Hands-on Intubation in the Simulation Lab with PI instructing:\n\n* Using state of the art technology, a Storz C-MAC video laryngoscope\n* Identifying anatomical landmarks\n* Practice on the manikin until intubation occurs within 15 seconds', 'armGroupLabels': ['Intervention: Receives Training']}, {'name': 'Intervention: Control No Training', 'type': 'OTHER', 'description': '• Does not receive simulation training with PI. Only standard training.', 'armGroupLabels': ['Intervention Control: No Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}], 'overallOfficials': [{'name': 'Richard W Hall, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arkansas'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arkansas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}