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OpenTrials
Completed

NCT Number: NCT02224612

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

Compare the fit of two pediatric face masks in children.

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Key information

Conditions

Healthy

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medline Industries, Inc

Mundelein, Illinois, 60060, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 4 to 12 years of age
  • conscious

Exclusion criteria

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

Treatment and study plan

Medline Pediatric Face Masks

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

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.

Primary outcomes

  1. Change From Baseline in Carbon Dioxide Levels

    Time frame: 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 outcomes

  1. Physical Fit of Pediatric Face Masks.

    Time frame: 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.

Other outcomes

  1. Change From Baseline in Respiration Rates

    Time frame: Baseline and 2 minutes

    Change from Baseline

Sponsors and collaborators

Lead sponsor

Medline Industries

Industry

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Aug 25, 2014
Registry last updated
Apr 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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