Trial Outcomes & Findings for A Comparative Evaluation of the Performance and Fit of Pediatric Face Masks (NCT NCT02224612)

Last Updated: 2019-04-23

Results Overview

ETCO2 will be assessed by a capnographer when wearing each pediatric face mask. Results are the difference between masks in change from baseline.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

96 participants

Primary outcome timeframe

Baseline and 2 minutes

Results posted on

2019-04-23

Participant Flow

Statistical analysis projected ninety-nine (99) Subjects were needed to assess mask equivalence, however only 96 subjects were enrolled at the facility.

Participant milestones

Participant milestones
Measure	Medline Face Mask First Medline Face Mask first, then KC Childs Mask	KC Childs Mask First KC Childs Mask first, then Medline Face Mask
Overall Study STARTED	48	48
Overall Study COMPLETED	48	48
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Partipants n=96 Participants All subjects were randomized to all interventions -- Medline Pediatric Face Mask and KC Childs
Age, Customized 4-5 years	19 Participants n=5 Participants
Age, Customized 6-9 years	45 Participants n=5 Participants
Age, Customized 10-12 years	32 Participants n=5 Participants
Sex: Female, Male Female	50 Participants n=5 Participants
Sex: Female, Male Male	46 Participants n=5 Participants
Region of Enrollment United States	96 participants n=5 Participants
EtCO2 Medline Mask	40.7 mmHg STANDARD_DEVIATION 4.4 • n=5 Participants
EtCO2 KC Mask	40.8 mmHg STANDARD_DEVIATION 4.3 • n=5 Participants
Respiration Rate Medline Mask	19.3 breaths per minute STANDARD_DEVIATION 3.4 • n=5 Participants
Respiration Rate KC Mask	19.0 breaths per minute STANDARD_DEVIATION 3.3 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Medline Pediatric Face Mask n=96 Participants All participants Medline Pediatric Face Mask	KC Childs Mask n=96 Participants All subjects KC Childs Mask
Change From Baseline in Carbon Dioxide Levels	-0.07 mmHg Standard Deviation 3.56	-0.79 mmHg Standard Deviation 0.65

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Medline Pediatric Face Mask n=96 Participants All participants Medline Pediatric Face Mask	KC Childs Mask All subjects KC Childs Mask
Physical Fit of Pediatric Face Masks. Medline Mask	.80 units on a scale Standard Deviation .79	—
Physical Fit of Pediatric Face Masks. KC Mask	.31 units on a scale Standard Deviation .59	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 2 minutes

Population: Respiration Rate

Change from Baseline

Outcome measures

Outcome measures
Measure	Medline Pediatric Face Mask n=96 Participants All participants Medline Pediatric Face Mask	KC Childs Mask All subjects KC Childs Mask
Change From Baseline in Respiration Rates Medline Mask	-1.14 Breaths per minute Standard Deviation .41	—
Change From Baseline in Respiration Rates KC Mask	-1.0 Breaths per minute Standard Deviation 2.8	—

Adverse Events

Medline Pediatric Face Mask

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

KC Childs Face Mask

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ed Drower

Medline Industries, Inc.

Phone: 847-643-3874

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place