A Comparative Evaluation of the Performance and Fit of Pediatric Face Masks
- Conditions
- Healthy
- Registration Number
- NCT02224612
- Lead Sponsor
- Medline Industries
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 96
- 4 to 12 years of age
- conscious
- able to wear a mask
- no previous allergic reactions to face masks
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Change From Baseline in Carbon Dioxide Levels 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 Outcome Measures
Name Time Method Physical Fit of Pediatric Face Masks. Immediate 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.
The 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.
Trial Locations
- Locations (1)
Medline Industries, Inc
🇺🇸Mundelein, Illinois, United States
Medline Industries, Inc🇺🇸Mundelein, Illinois, United States