Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2026-01-21 @ 12:08 PM
Study NCT ID:
NCT02224612
Status:
COMPLETED
Last Update Posted:
2019-04-23
First Post:
2014-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Comparative Evaluation of the Performance and Fit of Pediatric Face Masks
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'edrower@medline.com', 'phone': '847-643-3874', 'title': 'Ed Drower', 'organization': 'Medline Industries, Inc.'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 day', 'eventGroups': [{'id': 'EG000', 'title': 'Medline Pediatric Face Mask', 'description': 'Medline Face Mask', 'otherNumAtRisk': 96, 'deathsNumAtRisk': 96, 'otherNumAffected': 0, 'seriousNumAtRisk': 96, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'KC Childs Face Mask', 'description': 'KC Face Mask', 'otherNumAtRisk': 96, 'deathsNumAtRisk': 96, 'otherNumAffected': 0, 'seriousNumAtRisk': 96, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Carbon Dioxide Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Medline Pediatric Face Mask', 'description': 'All participants Medline Pediatric Face Mask'}, {'id': 'OG001', 'title': 'KC Childs Mask', 'description': 'All subjects KC Childs Mask'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.07', 'spread': '3.56', 'groupId': 'OG000'}, {'value': '-0.79', 'spread': '0.65', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 2 minutes', 'description': 'ETCO2 will be assessed by a capnographer when wearing each pediatric face mask. Results are the difference between masks in change from baseline.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Physical Fit of Pediatric Face Masks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Particpants', 'description': 'Medline Pediatric Face Mask KC Childs Face Mask'}], 'classes': [{'title': 'Medline Mask', 'categories': [{'measurements': [{'value': '.80', 'spread': '.79', 'groupId': 'OG000'}]}]}, {'title': 'KC Mask', 'categories': [{'measurements': [{'value': '.31', 'spread': '.59', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediate', 'description': 'Physical fit will be determined by a reviewer after the mask is put on. The fit will be based on a several fit parameters to compare the difference in the score between the two masks.\n\nThe total fit score was calculated by summing the nose to chine coverage score (0 = No, 1=Yes) and gap score (0=No apparent gap, flush to face on one or both sides, 1=Slight gap, not flush to face but can see cheeks only, 2=Moderate gap, can see mouth. , 3=Large gap, mask loose fitting all around face (chin, sides, nose, etc.) to arrive a total score with 0 indicating best fit and 4 indicating worst fit.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Respiration Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Medline Pediatric Face Mask KC Childs Face Mask'}], 'classes': [{'title': 'Medline Mask', 'categories': [{'measurements': [{'value': '-1.14', 'spread': '.41', 'groupId': 'OG000'}]}]}, {'title': 'KC Mask', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '2.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 2 minutes', 'description': 'Change from Baseline', 'unitOfMeasure': 'Breaths per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Respiration Rate'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Medline Face Mask First', 'description': 'Medline Face Mask first, then KC Childs Mask'}, {'id': 'FG001', 'title': 'KC Childs Mask First', 'description': 'KC Childs Mask first, then Medline Face Mask'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '48'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '48'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Statistical analysis projected ninety-nine (99) Subjects were needed to assess mask equivalence, however only 96 subjects were enrolled at the facility.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Partipants', 'description': 'All subjects were randomized to all interventions -- Medline Pediatric Face Mask and KC Childs'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '4-5 years', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}, {'title': '6-9 years', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}]}]}, {'title': '10-12 years', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '50', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '46', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '96', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'EtCO2', 'classes': [{'title': 'Medline Mask', 'categories': [{'measurements': [{'value': '40.7', 'spread': '4.4', 'groupId': 'BG000'}]}]}, {'title': 'KC Mask', 'categories': [{'measurements': [{'value': '40.8', 'spread': '4.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Respiration Rate', 'classes': [{'title': 'Medline Mask', 'categories': [{'measurements': [{'value': '19.3', 'spread': '3.4', 'groupId': 'BG000'}]}]}, {'title': 'KC Mask', 'categories': [{'measurements': [{'value': '19.0', 'spread': '3.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'breaths per minute', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-02', 'studyFirstSubmitDate': '2014-01-08', 'resultsFirstSubmitDate': '2017-08-29', 'studyFirstSubmitQcDate': '2014-08-21', 'lastUpdatePostDateStruct': {'date': '2019-04-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-02', 'studyFirstPostDateStruct': {'date': '2014-08-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change From Baseline in Respiration Rates', 'timeFrame': 'Baseline and 2 minutes', 'description': 'Change from Baseline'}], 'primaryOutcomes': [{'measure': 'Change From Baseline in Carbon Dioxide Levels', 'timeFrame': 'Baseline and 2 minutes', 'description': 'ETCO2 will be assessed by a capnographer when wearing each pediatric face mask. Results are the difference between masks in change from baseline.'}], 'secondaryOutcomes': [{'measure': 'Physical Fit of Pediatric Face Masks.', 'timeFrame': 'Immediate', 'description': 'Physical fit will be determined by a reviewer after the mask is put on. The fit will be based on a several fit parameters to compare the difference in the score between the two masks.\n\nThe total fit score was calculated by summing the nose to chine coverage score (0 = No, 1=Yes) and gap score (0=No apparent gap, flush to face on one or both sides, 1=Slight gap, not flush to face but can see cheeks only, 2=Moderate gap, can see mouth. , 3=Large gap, mask loose fitting all around face (chin, sides, nose, etc.) to arrive a total score with 0 indicating best fit and 4 indicating worst fit.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pediatric Face Masks', 'children'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Compare the fit of two pediatric face masks in children.', 'detailedDescription': 'This is a prospective, randomized, open-label comparative observational study to be conducted in up to two (2) facilities with the healthy and non-healthy Subjects (4-12 years of age). The usage of face masks is common practice within hospitals, and masks may be evaluated outside of clinical facilities as well.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 4 to 12 years of age\n* conscious\n\nExclusion Criteria:\n\n* able to wear a mask\n* no previous allergic reactions to face masks'}, 'identificationModule': {'nctId': 'NCT02224612', 'briefTitle': 'A Comparative Evaluation of the Performance and Fit of Pediatric Face Masks', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medline Industries'}, 'officialTitle': 'A Comparative Evaluation of the Performance and Fit of Pediatric Face Masks', 'orgStudyIdInfo': {'id': 'R13-044'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Children 4-5 yrs', 'description': 'Medline Pediatric Face Mask KC Childs Face Mask\n\nComparison of Medline Pediatric Face Masks and KC Childs Mask which are both single use disposable masks. Each mask (two in total) were worn for 2-3 minutes for EtCO2 and respiration assessments and physical fit assessment.', 'interventionNames': ['Device: Medline Pediatric Face Masks', 'Device: KC Childs Mask']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Children 6-9 yrs', 'description': 'Medline Pediatric Face Mask KC Childs Face Mask\n\nComparison of Medline Pediatric Face Masks and KC Childs Mask which are both single use disposable masks. Each mask (two in total) were worn for 2-3 minutes for EtCO2 and respiration assessments and physical fit assessment.', 'interventionNames': ['Device: Medline Pediatric Face Masks', 'Device: KC Childs Mask']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Children 10-12 yrs', 'description': 'Medline Pediatric Face Mask KC Childs Face Mask\n\nComparison of Medline Pediatric Face Masks and KC Childs Mask which are both single use disposable masks. Each mask (two in total) were worn for 2-3 minutes for EtCO2 and respiration assessments and physical fit assessment.', 'interventionNames': ['Device: Medline Pediatric Face Masks', 'Device: KC Childs Mask']}], 'interventions': [{'name': 'Medline Pediatric Face Masks', 'type': 'DEVICE', 'description': 'Medline Face Masks, which are single use disposable masks were evaluated on children. The mask was worn for 2-3 minutes for EtCO2 and respiration assessments and physical fit assessment.', 'armGroupLabels': ['Children 10-12 yrs', 'Children 4-5 yrs', 'Children 6-9 yrs']}, {'name': 'KC Childs Mask', 'type': 'DEVICE', 'description': 'KC Childs Mask, which are single use disposable masks were evaluated on children. The mask was worn for 2-3 minutes for EtCO2 and respiration assessments and physical fit assessment.', 'armGroupLabels': ['Children 10-12 yrs', 'Children 4-5 yrs', 'Children 6-9 yrs']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60060', 'city': 'Mundelein', 'state': 'Illinois', 'country': 'United States', 'facility': 'Medline Industries, Inc', 'geoPoint': {'lat': 42.26308, 'lon': -88.00397}}], 'overallOfficials': [{'name': 'Edward Drower, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medline Industries, Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medline Industries', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}