Ignite Creation Date:
2025-12-24 @ 4:03 PM
Ignite Modification Date:
2026-02-22 @ 4:26 AM
Study NCT ID:
NCT05059366
Status:
COMPLETED
Last Update Posted:
2022-07-18
First Post:
2021-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Manual Ventilation Efficacy With MVG Device
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-07-11', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'asabartinelli@med.miami.edu', 'phone': '305 585 8380', 'title': 'Alecia Sabartinelli Stein, MD', 'organization': 'University of Miami'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 day', 'description': 'The study is a cross-over design. All participants received both the MVG and 2VE intervention.', 'eventGroups': [{'id': 'EG000', 'title': 'Manual Ventilation Grip Device (MVG)', 'description': 'Manual Ventilation Grip Device is an add-on device placed on a standard valve mask to assist ventilation.', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 0, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard Technique (2VE)', 'description': 'The standard 2VE technique for ventilation', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 0, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Tidal Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experts Group', 'description': 'Anesthesiology residents and attendings with at least 2 or more years of clinical experience conducting both the Manual ventilation grip device (MVG) and the standard 2VE technique.'}, {'id': 'OG001', 'title': 'Novices Group', 'description': 'Current medical students or residents with no prior experience in hand mask ventilation techniques conducting both the Manual ventilation grip device (MVG) and the standard 2VE technique.'}], 'classes': [{'title': 'MVG technique', 'categories': [{'measurements': [{'value': '502.030', 'spread': '11.372', 'groupId': 'OG000'}, {'value': '492.508', 'spread': '10.220', 'groupId': 'OG001'}]}]}, {'title': '2VE technique', 'categories': [{'measurements': [{'value': '478.889', 'spread': '12.462', 'groupId': 'OG000'}, {'value': '481.533', 'spread': '11.200', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'As measured using the ventilator machine in milliliters', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '3 participants in the experts group were excluded due to unresolvable set-up obstacles'}, {'type': 'SECONDARY', 'title': 'Fatigue as Measured by NASA-TLX Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experts Group', 'description': 'Anesthesiology residents and attendings with at least 2 or more years of clinical experience conducting both the Manual ventilation grip device (MVG) and the standard 2VE technique.'}, {'id': 'OG001', 'title': 'Novices Group', 'description': 'Current medical students or residents with no prior experience in hand mask ventilation techniques conducting both the Manual ventilation grip device (MVG) and the standard 2VE technique.'}], 'classes': [{'title': 'MVG technique', 'categories': [{'measurements': [{'value': '33.92', 'spread': '5.23', 'groupId': 'OG000'}, {'value': '53.69', 'spread': '6.74', 'groupId': 'OG001'}]}]}, {'title': '2VE technique', 'categories': [{'measurements': [{'value': '42.54', 'spread': '5.24', 'groupId': 'OG000'}, {'value': '63.69', 'spread': '6.28', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'NASA Task Load Index (TLX) questionnaire has a total overall workload score ranging from 0 and 126 with the higher score indicating greater demand.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '3 participants in the experts group were excluded due to unresolvable set-up obstacles'}, {'type': 'SECONDARY', 'title': 'Fatigue as Measured by SOFI Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experts Group', 'description': 'Anesthesiology residents and attendings with at least 2 or more years of clinical experience conducting both the Manual ventilation grip device (MVG) and the standard 2VE technique.'}, {'id': 'OG001', 'title': 'Novices Group', 'description': 'Current medical students or residents with no prior experience in hand mask ventilation techniques conducting both the Manual ventilation grip device (MVG) and the standard 2VE technique.'}], 'classes': [{'title': 'MVG technique', 'categories': [{'measurements': [{'value': '13.08', 'spread': '3.32', 'groupId': 'OG000'}, {'value': '17.13', 'spread': '2.97', 'groupId': 'OG001'}]}]}, {'title': '2VE technique', 'categories': [{'measurements': [{'value': '16.38', 'spread': '3.13', 'groupId': 'OG000'}, {'value': '23.28', 'spread': '2.74', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'Swedish Occupational Fatigue Inventory (SOFI) questionnaire has a total score ranging from 0 to 120 with the higher score indicating greater fatigue', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '3 participants in the experts group were excluded due to unresolvable set-up obstacles'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Expert Participants Randomized to MVG Followed by 2VE', 'description': 'Expert participants (Anesthesiology residents and attendings with at least 2 or more years of clinical experience) randomized to perform the ventilation on a manikin using the Manual ventilation grip device (MVG) first followed by the standard 2VE technique alone.'}, {'id': 'FG001', 'title': 'Expert Participants Randomized to 2VE Followed by MVG', 'description': 'Expert participants (Anesthesiology residents and attendings with at least 2 or more years of clinical experience) randomized to perform the ventilation on a manikin using the standard technique (2VE) alone first followed by Manual ventilation grip device (MVG).'}, {'id': 'FG002', 'title': 'Novice Participants Randomized to MVG Followed by 2VE', 'description': 'Novice participants (Current medical students or residents with no prior experience in hand mask ventilation techniques) first followed by the standard technique (2VE) alone'}, {'id': 'FG003', 'title': 'Novice Participants Randomized to 2VE Followed by MVG', 'description': 'Novice participants (Current medical students or residents with no prior experience in hand mask ventilation techniques) randomized to perform the ventilation on a manikin using the standard technique (2VE) alone first followed by Manual ventilation grip device (MVG)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Experts Group', 'description': 'Anesthesiology residents and attendings with at least 2 or more years of clinical experience conducting both the Manual ventilation grip device (MVG) and the standard 2VE technique.'}, {'id': 'BG001', 'title': 'Novices Group', 'description': 'Current medical students or residents with no prior experience in hand mask ventilation techniques conducting both the Manual ventilation grip device (MVG) and the standard 2VE technique.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}], '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': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', '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': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-04-21', 'size': 407382, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-06-10T14:21', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'The study is a repeated-measures cross over design.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2021-08-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-15', 'studyFirstSubmitDate': '2021-09-03', 'resultsFirstSubmitDate': '2022-06-14', 'studyFirstSubmitQcDate': '2021-09-19', 'lastUpdatePostDateStruct': {'date': '2022-07-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-07-15', 'studyFirstPostDateStruct': {'date': '2021-09-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tidal Volume', 'timeFrame': 'Day 1', 'description': 'As measured using the ventilator machine in milliliters'}], 'secondaryOutcomes': [{'measure': 'Fatigue as Measured by NASA-TLX Questionnaire', 'timeFrame': 'Day 1', 'description': 'NASA Task Load Index (TLX) questionnaire has a total overall workload score ranging from 0 and 126 with the higher score indicating greater demand.'}, {'measure': 'Fatigue as Measured by SOFI Questionnaire', 'timeFrame': 'Day 1', 'description': 'Swedish Occupational Fatigue Inventory (SOFI) questionnaire has a total score ranging from 0 to 120 with the higher score indicating greater fatigue'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Manual Ventilation Grip Device'], 'conditions': ['Ventilator Lung']}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to investigate the efficacy of the newly designed ventilation grip device (MVG device).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Current medical students, Post Graduate Year 1 (PGY1) residents or residents from other specialties with no prior experience in hand mask ventilation techniques or anesthesiology residents and attendings with at least 2 or more years of clinical experience\n\nExclusion Criteria:\n\n1. Refusal to participate in the study.\n2. Medical students with prior experience in hand mask ventilation techniques (i.e. experiences in previous careers such as nursing or Emergency Medical Technician (EMT) professions)\n3. Any physical inability to adequately perform ventilation'}, 'identificationModule': {'nctId': 'NCT05059366', 'briefTitle': 'Manual Ventilation Efficacy With MVG Device', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Improvement of Manual Ventilation Efficacy With Ventilation Grip Device: A Manikin Study', 'orgStudyIdInfo': {'id': '20200039'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Expert participants randomized to MVG followed by 2VE', 'description': 'Expert participants (Anesthesiology residents and attendings with at least 2 or more years of clinical experience) randomized to perform the ventilation on a manikin using the Manual ventilation grip device (MVG) first followed by the standard 2VE technique alone.', 'interventionNames': ['Device: Manual Ventilation Grip Device', 'Other: 2VE']}, {'type': 'EXPERIMENTAL', 'label': 'Expert participants randomized to 2VE followed by MVG', 'description': 'Expert participants (Anesthesiology residents and attendings with at least 2 or more years of clinical experience) randomized to perform the ventilation on a manikin using the standard technique (2VE) alone first followed by Manual ventilation grip device (MVG).', 'interventionNames': ['Device: Manual Ventilation Grip Device', 'Other: 2VE']}, {'type': 'EXPERIMENTAL', 'label': 'Novice participants randomized to MVG followed by 2VE', 'description': 'Novice participants (Current medical students or residents with no prior experience in hand mask ventilation techniques) first followed by the standard technique (2VE) alone', 'interventionNames': ['Device: Manual Ventilation Grip Device', 'Other: 2VE']}, {'type': 'EXPERIMENTAL', 'label': 'Novice participants randomized to 2VE followed by MVG', 'description': 'Novice participants (Current medical students or residents with no prior experience in hand mask ventilation techniques) randomized to perform the ventilation on a manikin using the standard technique (2VE) alone first followed by Manual ventilation grip device (MVG)', 'interventionNames': ['Device: Manual Ventilation Grip Device', 'Other: 2VE']}], 'interventions': [{'name': 'Manual Ventilation Grip Device', 'type': 'DEVICE', 'description': 'Manual Ventilation Grip Device is an add-on device placed on a standard valve mask to assist ventilation.', 'armGroupLabels': ['Expert participants randomized to 2VE followed by MVG', 'Expert participants randomized to MVG followed by 2VE', 'Novice participants randomized to 2VE followed by MVG', 'Novice participants randomized to MVG followed by 2VE']}, {'name': '2VE', 'type': 'OTHER', 'description': 'the standard 2VE technique for ventilation', 'armGroupLabels': ['Expert participants randomized to 2VE followed by MVG', 'Expert participants randomized to MVG followed by 2VE', 'Novice participants randomized to 2VE followed by MVG', 'Novice participants randomized to MVG followed by 2VE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Alecia Stein', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Clinical', 'investigatorFullName': 'Alecia Stein', 'investigatorAffiliation': 'University of Miami'}}}}