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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-01-31

Brief Summary

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Compare the fit of two pediatric face masks in children.

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Children 4-5 yrs

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.

Group Type ACTIVE_COMPARATOR

Medline Pediatric Face Masks

Intervention Type DEVICE

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.

KC Childs Mask

Intervention Type DEVICE

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.

Children 6-9 yrs

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.

Group Type ACTIVE_COMPARATOR

Medline Pediatric Face Masks

Intervention Type DEVICE

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.

KC Childs Mask

Intervention Type DEVICE

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.

Children 10-12 yrs

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.

Group Type ACTIVE_COMPARATOR

Medline Pediatric Face Masks

Intervention Type DEVICE

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.

KC Childs Mask

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE