Healthy
Conditions
Keywords
Pediatric Face Masks, children
Brief 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.
Interventions
DEVICEMedline 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.
DEVICEKC 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.
Sponsors
Medline Industries
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
Yes
Inclusion criteria
* 4 to 12 years of age * conscious
Exclusion criteria
* able to wear a mask * no previous allergic reactions to face masks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Carbon Dioxide Levels | 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
| Measure | Time frame | Description |
|---|---|---|
| Physical Fit of Pediatric Face Masks. | 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
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Respiration Rates | Baseline and 2 minutes | Change from Baseline |
Countries
United States
Participant flow
Pre-assignment details
Statistical analysis projected ninety-nine (99) Subjects were needed to assess mask equivalence, however only 96 subjects were enrolled at the facility.
Participants by arm
| Arm | Count |
|---|---|
| All Study Partipants All subjects were randomized to all interventions -- Medline Pediatric Face Mask and KC Childs | 96 |
| Total | 96 |
Baseline characteristics
| Characteristic | All Study Partipants |
|---|---|
| Age, Customized 10-12 years | 32 Participants |
| Age, Customized 4-5 years | 19 Participants |
| Age, Customized 6-9 years | 45 Participants |
| EtCO2 KC Mask | 40.8 mmHg STANDARD_DEVIATION 4.3 |
| EtCO2 Medline Mask | 40.7 mmHg STANDARD_DEVIATION 4.4 |
| Region of Enrollment United States | 96 participants |
| Respiration Rate KC Mask | 19.0 breaths per minute STANDARD_DEVIATION 3.3 |
| Respiration Rate Medline Mask | 19.3 breaths per minute STANDARD_DEVIATION 3.4 |
| Sex: Female, Male Female | 50 Participants |
| Sex: Female, Male Male | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 96 | 0 / 96 |
| other Total, other adverse events | 0 / 96 | 0 / 96 |
| serious Total, serious adverse events | 0 / 96 | 0 / 96 |
Outcome results
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.
Time frame: Baseline and 2 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medline Pediatric Face Mask | Change From Baseline in Carbon Dioxide Levels | -0.07 mmHg | Standard Deviation 3.56 |
| KC Childs Mask | Change From Baseline in Carbon Dioxide Levels | -0.79 mmHg | Standard Deviation 0.65 |
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.
Time frame: Immediate
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Medline Pediatric Face Mask | Physical Fit of Pediatric Face Masks. | Medline Mask | .80 units on a scale | Standard Deviation 0.79 |
| Medline Pediatric Face Mask | Physical Fit of Pediatric Face Masks. | KC Mask | .31 units on a scale | Standard Deviation 0.59 |
Other Pre-specified
Change From Baseline in Respiration Rates
Change from Baseline
Time frame: Baseline and 2 minutes
Population: Respiration Rate
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Medline Pediatric Face Mask | Change From Baseline in Respiration Rates | Medline Mask | -1.14 Breaths per minute | Standard Deviation 0.41 |
| Medline Pediatric Face Mask | Change From Baseline in Respiration Rates | KC Mask | -1.0 Breaths per minute | Standard Deviation 2.8 |