A Comparative Evaluation of the Performance and Fit of Pediatric Face Masks
1 other identifier
interventional
96
1 country
1
Brief Summary
Compare the fit of two pediatric face masks in children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 healthy
Started Jan 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 8, 2014
CompletedFirst Posted
Study publicly available on registry
August 25, 2014
CompletedResults Posted
Study results publicly available
April 23, 2019
CompletedApril 23, 2019
August 1, 2017
Same day
January 8, 2014
August 29, 2017
April 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Carbon Dioxide Levels
ETCO2 will be assessed by a capnographer when wearing each pediatric face mask. Results are the difference between masks in change from baseline.
Baseline and 2 minutes
Secondary Outcomes (1)
Physical Fit of Pediatric Face Masks.
Immediate
Other Outcomes (1)
Change From Baseline in Respiration Rates
Baseline and 2 minutes
Study Arms (3)
Children 4-5 yrs
ACTIVE COMPARATORMedline Pediatric Face Mask KC Childs Face Mask Comparison 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.
Children 6-9 yrs
ACTIVE COMPARATORMedline Pediatric Face Mask KC Childs Face Mask Comparison 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.
Children 10-12 yrs
ACTIVE COMPARATORMedline Pediatric Face Mask KC Childs Face Mask Comparison 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- to 12 years of age
- conscious
You may not qualify if:
- able to wear a mask
- no previous allergic reactions to face masks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medline Industries, Inc
Mundelein, Illinois, 60060, United States
Results Point of Contact
- Title
- Ed Drower
- Organization
- Medline Industries, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Edward Drower, MS
Medline Industries, Inc
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2014
First Posted
August 25, 2014
Study Start
January 1, 2014
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
April 23, 2019
Results First Posted
April 23, 2019
Record last verified: 2017-08