A Comparative Evaluation of the Performance and Fit of Pediatric Face Masks

Study Overview
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Brief Summary
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Compare the fit of two pediatric face masks in children.

Detailed Description
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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.

Official Title
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A Comparative Evaluation of the Performance and Fit of Pediatric Face Masks

Conditions
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Healthy

Intervention / Treatment
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* Device: Medline Pediatric Face Masks
* Device: KC Childs Mask


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 4 to 12 years of age conscious Exclusion Criteria: able to wear a mask no previous allergic reactions to face masks

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Children 4-5 yrs<br>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. | Device: Medline Pediatric Face Masks<br>* 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.<br>Device: KC Childs Mask<br>* 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.<br>|
| Active Comparator: Children 6-9 yrs<br>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. | Device: Medline Pediatric Face Masks<br>* 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.<br>Device: KC Childs Mask<br>* 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.<br>|
| Active Comparator: Children 10-12 yrs<br>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. | Device: Medline Pediatric Face Masks<br>* 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.<br>Device: KC Childs Mask<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Fit of Pediatric Face Masks. | 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. | Immediate | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric Face Masks, children