A Comparative Evaluation of the Performance and Fit of Pediatric Face Masks
- Conditions
- Healthy
- Interventions
- Device: Medline Pediatric Face MasksDevice: KC Childs Mask
- 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
- Arm && Interventions
Group Intervention Description Children 4-5 yrs Medline Pediatric Face Masks Medline 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 KC Childs Mask Medline 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 KC Childs Mask Medline 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 4-5 yrs KC Childs Mask Medline 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 Medline Pediatric Face Masks Medline 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 Medline Pediatric Face Masks Medline 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.
- 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