NCT02224612

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Medline Industries · Industry
• Sex: All
• Age: 4 Years – 12 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DEVICE	Medline Pediatric Face Masks	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.
DEVICE	KC Childs Mask	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.

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2014-08-25
• Last updated: 2019-04-23
• Results posted: 2019-04-23

Locations

1 site across 1 country: United States