Clinical trial NCT04454606: The New Silicone N99 Half-Piece Respirator
Official title: The New Silicone N99 Half-Piece Respirator:VJR-NMU N99:New and Effective Tool to Prevent COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID
Personal Protective Equipment
Keywords: respirators
n99
COVID-19
Lead sponsor: Bangkok Metropolitan Administration Medical College and Vajira Hospital
Sponsor class: OTHER_GOV
First posted: 2020-07-01
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: N99 respirators will be tested in a group of subjects with qualitative fit test.The filters will be tested for filtration test.The results will be considered as pass or fail
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Healthcare workers

Exclusion Criteria:

* Intolerance to exercise
* cannot taste bitter sensation

Primary outcomes:
measure: Fit test
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
measure: Filtration test
timeFrame: Day 1
Locations:
city: Bangkok
country: Thailand
facility: Bangkok Metroplitan Administration and Vajira Hospital
Study officials:
affiliation: Bangkok Metropolitan Administration and Vajira Hospital
name: Thananda Trakarnvanich, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
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):981. doi: 10.1038/s41591-020-0946-9.