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

M

Medline Industries

Status and phase

Completed

Phase 4

Conditions

Healthy

Treatments

Device: Medline Pediatric Face Masks

Device: KC Childs Mask

Study type

Interventional

Funder types

Industry

Identifiers

NCT02224612

R13-044

Details and patient eligibility

About

Compare the fit of two pediatric face masks in children.

Full 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.

Enrollment

96 patients

Sex

All

Ages

4 to 12 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

4 to 12 years of age
conscious

Exclusion criteria

able to wear a mask
no previous allergic reactions to face masks

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

96 participants in 3 patient groups

Children 4-5 yrs

Active Comparator group

Description:

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.

Treatment:

Device: Medline Pediatric Face Masks

Device: KC Childs Mask

Children 6-9 yrs

Active Comparator group

Description:

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.

Treatment:

Device: Medline Pediatric Face Masks

Device: KC Childs Mask

Children 10-12 yrs

Active Comparator group

Description:

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.

Treatment:

Device: Medline Pediatric Face Masks

Device: KC Childs Mask

Trial contacts and locations

1

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