NCT02224612CompletedPhase 4
A Comparative Evaluation of the Performance and Fit of Pediatric Face Masks
Medline Industries2 sites in 1 country96 target enrollmentStarted: January 1, 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 96
- Locations
- 2
- Primary Endpoint
- Change From Baseline in Carbon Dioxide Levels
Study Overview
Brief Summary
Compare the fit of two pediatric face masks in children.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 4 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •4 to 12 years of age
- •conscious
Exclusion Criteria
- •able to wear a mask
- •no previous allergic reactions to face masks
Outcomes
Primary Outcomes
Change From Baseline in Carbon Dioxide Levels
Time Frame: Baseline and 2 minutes
ETCO2 will be assessed by a capnographer when wearing each pediatric face mask. Results are the difference between masks in change from baseline.
Secondary Outcomes
- Physical Fit of Pediatric Face Masks.(Immediate)
Investigators
Study Sites (2)
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