The New Silicone N99 Half-Piece Respirator

NACompletedINTERVENTIONAL
Enrollment

43

Participants

Timeline

Start Date

May 1, 2020

Primary Completion Date

May 15, 2020

Study Completion Date

May 31, 2020

Conditions
COVIDPersonal Protective Equipment
Interventions
DEVICE

Fit test

"Bitrex Fit Test The Bitrex test uses a person's ability to test a bitter solution to determine whether a respirator fits properly\[11\]. Each subject was given a taste-threshold screening test prior to each fit test to ensure that he or she could taste. This process was done without subject wearing a respirator. After passing the sensitivity test, the subject will process to 7 steps of fit test as following~* Breathe normally~* Breathe deeply~* Head side to side~* Head up and down~* Bent over wrist, jogging~* Talking~* Breath normally Each step took 60 seconds and the Bitrex solution was refilled into the hood every 30 seconds with half dosage of the amount of the previously test. We asked the participant if he / she could taste the solution during each steps of the test . The test was considered a failure, otherwise, a pass."

DEVICE

Filtration Test

"Respirator Performance~The real time respirator performance test method was developed using MT-05U machine (SIBATA model, Saitama, Japan), which measure particle concentrations of diameter 0.03 - 0.06 µm using and particle generator laser beam scattering particle counter that measure particles outside and inside the mask. The ratio between these two values reflected % leak as following:~* leak=((Paticle inside the filter))/((Paticle inside the filter)) x 100 And calculate % filter performance = 100 - % leak We tested at the airflow rate of 40L/min which is 3-4 times higher than normal physiology, assuming that there should be no leakage through the filter. We tested 2 types of filter is CareStar and SafeStar that was incorporated with the silicone mask. CareStar is limited for 24 hour usage and SafeStar is for 72 hour duration.~Study protocol"

Trial Locations (1)

10300

Bangkok Metroplitan Administration and Vajira Hospital, Bangkok

All Listed Sponsors
lead

Bangkok Metropolitan Administration Medical College and Vajira Hospital

OTHER_GOV

NCT04454606 - The New Silicone N99 Half-Piece Respirator | Biotech Hunter | Biotech Hunter