The New Silicone N99 Half-Piece Respirator

COVID Clinical Trial

Official title:

The New Silicone N99 Half-Piece Respirator:VJR-NMU N99:New and Effective Tool to Prevent COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04454606
• Other study ID #: 053/2563
• Status: Completed
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: May 31, 2020

Study information

• Verified date: June 2020
• Source: Bangkok Metropolitan Administration Medical College and Vajira Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Filter facepiece respirator (FFR) is a critical equipment to prevent the transmission of respiratory tract infection disease especially the dreadful corona virus 2(SARs-CoV-2).The N95 mask is the prototype of high efficiency protective device and can effectively protect airborne pathogens of less than 0.3 μm by more than 95%. It is tightly fit and had high filtration capacity. The widespread pandemic of COVID-19 leads to greater requirement of FFR. A rising in demand would greatly exceed current productive capabilities and stockpiles and would almost certainly result in a robust shortage.

In order to solve these problems, our team had invented a new type of half-piece respirator made from silicone and assembled with hepa or elastostatic filter . A variety of methods have been used to evaluate this new device, including qualitative fit test with Bitrex® test kit and filtration test.

Description:

As required by Occupational Safety and Health Administration OSHA)[7], the halfpiece respirators need to pass the fittestto identify those individuals who do not achieve the good fit necessary for adequate protection. The performance of this respirator was also determined by measuring percent leakage under constant airflow[8]. The purposes of this study was to evaluate the fitting characteristicof our newly invented silicone N99 respirator and the performance against 30 µm particles using NaCL aerosols. The study was conducted to achieve two specific research objectives

1. To investigate the fit characteristic of the novel silicone mask and whether the strap adjustment can help reduce the face-seal leakage

2. To determine the level of performance by measure the inward leakage of the generated aerosolswith the new filter and used filter for up to 24 hours.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: May 31, 2020
• Est. primary completion date: May 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Healthcare workers

Exclusion Criteria:

• Intolerance to exercise

• cannot taste bitter sensation

Related Conditions & MeSH terms

• COVID
• Personal Protective Equipment

Intervention

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.
• 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

Locations

Country	Name	City	State
Thailand	Bangkok Metroplitan Administration and Vajira Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Bangkok Metropolitan Administration Medical College and Vajira Hospital

Country where clinical trial is conducted

Thailand, 

References & Publications (4)

5.Occupational Safety and health Administration(OSHA): 29 CFR parts 1910 and 1926 Respiratory Protection: Final Rule. Federal Register 63(5): 1278-1279. Washington, D.C: U.S. Government Printing Office, Office of the Federal Register, January 8,1998.

Coffey C, Zhuang Z, Campbell D. Evaluation of the BitrixTM qualitative fit test method using N95 filtering-facepiece respirators. J Int Soc Respir Prot 1998: 16 : 48-55.

Gralton J, Tovey E, McLaws ML, Rawlinson WD. The role of particle size in aerosolised pathogen transmission: a review. J Infect. 2011 Jan;62(1):1-13. doi: 10.1016/j.jinf.2010.11.010. Epub 2010 Nov 19. Review. — View Citation

Leung NHL, Chu DKW, Shiu EYC, Chan KH, McDevitt JJ, Hau BJP, Yen HL, Li Y, Ip DKM, Peiris JSM, Seto WH, Leung GM, Milton DK, Cowling BJ. Author Correction: Respiratory virus shedding in exhaled breath and efficacy of face masks. Nat Med. 2020 Jun;26(6):98 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Filtration test	percent leakage less than1 percent	Day 1
Primary	Fit test	pass or fail	Day 1