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Compare the fit of two pediatric face masks in children.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children 4-5 yrs | Active Comparator | 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. |
|
| Children 6-9 yrs | Active Comparator | 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. |
|
| Children 10-12 yrs | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Respiration Rates | Change from Baseline | Baseline and 2 minutes |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edward Drower, MS | Medline Industries | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medline Industries, Inc | Mundelein | Illinois | 60060 | United States |
Statistical analysis projected ninety-nine (99) Subjects were needed to assess mask equivalence, however only 96 subjects were enrolled at the facility.
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| ID | Title | Description |
|---|---|---|
| FG000 | Medline Face Mask First | Medline Face Mask first, then KC Childs Mask |
| FG001 | KC Childs Mask First | KC Childs Mask first, then Medline Face Mask |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Partipants | All subjects were randomized to all interventions -- Medline Pediatric Face Mask and KC Childs |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | mmHg | Baseline and 2 minutes |
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|
1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Medline Pediatric Face Mask | Medline Face Mask | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ed Drower | Medline Industries, Inc. | 847-643-3874 | edrower@medline.com |
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| 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. |
|
| Immediate |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| EtCO2 | Mean | Standard Deviation | mmHg |
|
| Respiration Rate | Mean | Standard Deviation | breaths per minute |
|
| Participants |
|
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| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Immediate |
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|
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| Other Pre-specified | Change From Baseline in Respiration Rates | Change from Baseline | Respiration Rate | Posted | Mean | Standard Deviation | Breaths per minute | Baseline and 2 minutes |
|
|
|
| 96 |
| 0 |
| 96 |
| 0 |
| 96 |
| EG001 | KC Childs Face Mask | KC Face Mask | 0 | 96 | 0 | 96 | 0 | 96 |
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