The New Silicone N99 Half-Piece Respirator

NCT04454606 | Completed DMC

• 1 other identifier: 053/2563
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID; Personal Protective Equipment

Keywords

respirators; n99; COVID-19

Outcome Measures

Primary Outcomes (1)

• Fit test

  pass or fail

  Day 1

Other Outcomes (1)

• Filtration test

  Day 1

Study Arms (1)

Fit test

EXPERIMENTAL

All the subjects will be tested for fit test

Device: Fit test; Device: Filtration Test

Interventions

Fit test DEVICE

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.

Fit test

Filtration Test DEVICE

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

Fit test

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthcare workers

You may not qualify if:

• Intolerance to exercise
• cannot taste bitter sensation

Sponsors & Collaborators

• Bangkok Metropolitan Administration Medical College and Vajira Hospital: lead

Study Sites (1)

Bangkok Metroplitan Administration and Vajira Hospital

Bangkok, 10300, Thailand

Location

Related Publications (4)

• 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.

  PMID: 21094184 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 32461699 RESULT

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Thananda Trakarnvanich, M.D.

  Bangkok Metropolitan Administration and Vajira Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: July 1, 2020
• Study Start: May 1, 2020
• Primary Completion: May 15, 2020
• Study Completion: May 31, 2020
• Last Updated: July 1, 2020

Record last verified: 2020-06

Locations

TH (1)