Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-02-03 @ 4:45 AM
Study NCT ID:
NCT03194503
Status:
COMPLETED
Last Update Posted:
2021-04-09
First Post:
2017-05-04
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Tracheal Intubation Coaching in NICUs
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-06-02', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'NISHISAKI@email.chop.edu', 'phone': '267-426-0665', 'title': 'Dr. Akira Nishisaki', 'organization': "The Children's Hospital of Philadelphia"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected for 18 months from January 1, 2018 to June 30, 2019.', 'description': 'Study procedures are not greater than minimal risk, SAE are not expected. If unanticipated problems related to the research involving risks to subjects or others happened during the course of the study (including SAEs) they would be reported to the IRB. in accordance with CHOP IRB SOP 408: Unanticipated Problems Involving Risks to Subjects. AEs that are not serious but that are notable and could involve risks to subjects will be summarized in narrative or other format and submitted to the IRB.', 'eventGroups': [{'id': 'EG000', 'title': 'Pre-Intervention', 'description': 'Intubations before VL coaching using train-the-trainer mechanism was implemented..', 'otherNumAtRisk': 458, 'deathsNumAtRisk': 458, 'otherNumAffected': 0, 'seriousNumAtRisk': 458, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Post-Intervention', 'description': 'Intubations after VL coaching using train-the-trainer mechanism was implemented.', 'otherNumAtRisk': 1054, 'deathsNumAtRisk': 1054, 'otherNumAffected': 0, 'seriousNumAtRisk': 1054, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Tracheal Intubation Associated Events (TIAEs) in the NICU Over 2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '458', 'groupId': 'OG000'}, {'value': '1054', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-Intervention', 'description': 'Intubations before VL coaching using train-the-trainer mechanism was implemented.'}, {'id': 'OG001', 'title': 'Post-Intervention', 'description': 'Intubations after VL coaching using train-the-trainer mechanism was implemented.'}], 'classes': [{'title': 'Any TIAEs', 'categories': [{'measurements': [{'value': '138', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}]}, {'title': 'Severe TIAEs', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'Severe Desaturation (>20%)', 'categories': [{'measurements': [{'value': '244', 'groupId': 'OG000'}, {'value': '491', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.015', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.65', 'ciLowerLimit': '0.47', 'ciUpperLimit': '0.92', 'groupDescription': 'This statistical analysis applies to all three rows in the post-intervention column. ITT analysis: Multivariable analysis for Any TIAEs, Severe TIAEs, and Severe desaturation(\\>20%)', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 years', 'description': 'Reduction in the occurrence of adverse tracheal intubation associated events among all tracheal intubations in neonatal ICUs over 2 years after neonatology attendings receive video coaching skill training.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary outcome is comparing the number of participants with intubations before the intervention implementation phase (n=458) and the number of participants with intubations in the post intervention implementation phase (n=1,054), total n=1,512 for outcome 1.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Severe Oxygen Desaturation (>20% Decline in SpO2) Among Those With VL Coaching and Without VL Coaching', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '984', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'VL Coaching', 'description': 'Intubations where the intubator (trainee) was coached by an attending to use Video Laryngoscopy.'}, {'id': 'OG001', 'title': 'No VL Coaching (Including DL&VL)', 'description': 'Intubations where the intubator was not coached to use Video Laryngoscopy or direct laryngoscopy was used.'}], 'classes': [{'title': 'Any TIAEs', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}]}, {'title': 'Severe TIAEs', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}, {'title': 'Severe Desaturation (>20%)', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '438', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.250', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.77', 'ciLowerLimit': '0.50', 'ciUpperLimit': '1.20', 'groupDescription': 'This statistical analysis applies to all three rows and is a per-protocol analysis: Multivariable analysis for Any TIAEs, Severe TIAEs, and Severe desaturation(\\>20%)', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '18 months', 'description': 'Intubations with VL coaching vs. no VL coaching (incl: DL\\&VL) can reduce severe oxygen desaturation:\n\nOxygen desaturation defined as highest -lowest SpO2 during the intubation is \\>20% (absolute value). Intervention timing was randomized based on the site size.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants in this outcome measure include those intubated with VL coaching (n=155) and those intubated without VL coaching (n=984), total n=1,139 for outcome measure 2.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pre-Intervention', 'description': 'Intubations before VL coaching using train-the-trainer mechanism was implemented.'}, {'id': 'FG001', 'title': 'Post- Intervention', 'description': 'Intubations after VL coaching using train-the-trainer mechanism was implemented.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '458'}, {'groupId': 'FG001', 'numSubjects': '1054'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '458'}, {'groupId': 'FG001', 'numSubjects': '1054'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '458', 'groupId': 'BG000'}, {'value': '1054', 'groupId': 'BG001'}, {'value': '1512', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pre-Intervention', 'description': 'Intubations before VL coaching using train-the-trainer mechanism was implemented.'}, {'id': 'BG001', 'title': 'Post-Intervention', 'description': 'Intubations after VL coaching using train-the-trainer mechanism was implemented.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '458', 'groupId': 'BG000'}, {'value': '1054', 'groupId': 'BG001'}, {'value': '1512', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '196', 'groupId': 'BG000'}, {'value': '452', 'groupId': 'BG001'}, {'value': '648', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '262', 'groupId': 'BG000'}, {'value': '602', 'groupId': 'BG001'}, {'value': '864', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '161', 'groupId': 'BG001'}, {'value': '231', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '329', 'groupId': 'BG000'}, {'value': '759', 'groupId': 'BG001'}, {'value': '1088', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '90', '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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-06-26', 'size': 539974, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-05-11T12:09', 'hasProtocol': True}, {'date': '2018-01-30', 'size': 184189, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-03-15T12:47', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1512}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-16', 'studyFirstSubmitDate': '2017-05-04', 'resultsFirstSubmitDate': '2020-05-11', 'studyFirstSubmitQcDate': '2017-06-19', 'lastUpdatePostDateStruct': {'date': '2021-04-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-06-25', 'studyFirstPostDateStruct': {'date': '2017-06-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Tracheal Intubation Associated Events (TIAEs) in the NICU Over 2 Years', 'timeFrame': '2 years', 'description': 'Reduction in the occurrence of adverse tracheal intubation associated events among all tracheal intubations in neonatal ICUs over 2 years after neonatology attendings receive video coaching skill training.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Severe Oxygen Desaturation (>20% Decline in SpO2) Among Those With VL Coaching and Without VL Coaching', 'timeFrame': '18 months', 'description': 'Intubations with VL coaching vs. no VL coaching (incl: DL\\&VL) can reduce severe oxygen desaturation:\n\nOxygen desaturation defined as highest -lowest SpO2 during the intubation is \\>20% (absolute value). Intervention timing was randomized based on the site size.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Intubation', 'Video Laryngoscope', 'Coaching/training'], 'conditions': ['Failed or Difficult Intubation, Sequela', 'Intubation;Difficult', 'Intubation Complication']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine the efficacy of video coaching training for neonatology attending providers on tracheal intubation procedural outcomes in neonatal ICUs.', 'detailedDescription': 'Tracheal intubation (TI) is the most common life-saving intervention for resuscitation and stabilization of critically ill neonates in Neonatal Intensive Care Units (NICUs).Recently, video laryngoscopy (VL) has become available in neonatal clinical practice to allows trainees and frontline providers to perform standard direct airway visualization (i.e., traditional laryngoscopy) while the supervisor can simultaneously view a real-time video displaying what the laryngoscopist is seeing. However, VL associated coaching during TI has not been rigorously evaluated.The purpose of the study is to determine the efficacy of video coaching training for neonatology attending providers on tracheal intubation procedural outcomes in neonatal ICUs. The primary objective of this study is to determine whether the video coaching skill training for neonatology attendings reduces the occurrence of adverse tracheal intubation associated events among all tracheal intubations in neonatal ICUs over 2 years before and after intervention. The secondary objectives are to 1) determine if video coaching training is feasible to all neonatology attending physicians using train the trainer approach with a remote simulation and 2) determine if the video coaching skill competency among neonatology attending physicians who completed the training using a remote simulation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. VL coach: Neonatology attending physician position at each neonatal ICU, or Senior trainees who are anticipated to graduate within next 6 months to become neonatology attending physicians.\n2. VL coach receivers: Trainees (medical students, residents, fellows except those graduating within next 6 months) and frontline providers (nurse practitioners, hospitalists, physician assistants, respiratory therapists, others who perform tracheal intubations under attending physicians' supervision)\n\nExclusion Criteria:\n\nNone"}, 'identificationModule': {'nctId': 'NCT03194503', 'briefTitle': 'Tracheal Intubation Coaching in NICUs', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Philadelphia"}, 'officialTitle': 'Improving Safety and Quality of Tracheal Intubations in Neonatal ICUs', 'orgStudyIdInfo': {'id': '16-013606'}, 'secondaryIdInfos': [{'id': '1R21HD089151-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R21HD089151-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Attendings', 'description': 'Study intervention is a VL coaching training for site neonatology attendings. Each site leader/key educator will be trained remotely by expert co-investigators. Site leaders and key educators will train their attendings. The quality of VL coaching skills will be verified by randomly auditing 20% of attending providers at each site for their skill assessment by remote simulation during the transition/post-intervention phase.', 'interventionNames': ['Device: VL Coaching training using C-MAC video laryngoscope']}, {'type': 'NO_INTERVENTION', 'label': 'Trainees', 'description': 'Trainees will be coached as usual by attendings during their supervised intubation events'}], 'interventions': [{'name': 'VL Coaching training using C-MAC video laryngoscope', 'type': 'DEVICE', 'description': "Each neonatology attending providers will receive a video laryngoscopy coaching training using a C-MAC video laryngoscope and an intubation training manikin available at each site by a site leader. During the training, site leader will act as a trainee confederate, and each neonatology attending provider will be trained to coach a trainee utilizing video images from C-MAC video laryngoscope and a cognitive aid with standardized language in a laminated card. This training part typically takes approximately 15-30 minutes including consenting process.\n\nEach site leader will be trained by PI or PI's designee using remote simulation. In this remote simulation, each site leader will coach an actor at the Children's Hospital of Philadelphia (CHOP) using a profile video image and C-MAC video laryngoscopy image through CHOP approved video conferencing software. A standardized language will be taught to each site leader with a cognitive aid (laminated card).", 'armGroupLabels': ['Attendings']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Diego Jacobs Medical Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Hospital', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': "Yale New Haven Children's Hospital", 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '03766', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth-Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '27610', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'WakeMed', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State Health Milton S. Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Seattle Children's Hospital", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': 'QC H3T 1C5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CHU Sainte-Justine', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '168753', 'city': 'Singapore', 'country': 'Singapore', 'facility': "KK Women's and Children's Hospital", 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Akira Nishisaki, MD, MSCE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Philadelphia"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Philadelphia", 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Washington', 'class': 'OTHER'}, {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}